Friday, July 29, 2016

Patient Centricity and Improving the Clinical Trial Process


The Partnerships in Clinical Trials team were able to sit down with Jack Whelan for an exclusive interview. Jack will be joining the speaking faculty at the conference in October and is a very active research advocate determined to help improve the clinical trial process. Jack himself has participated in seven clinical trials, and is an eight year survivor of a rare incurable blood cancer. The unique patient perspective that Jack is able provide is one you won't soon forget. It is time for some fresh new thinking about clinical trials.

Continue Reading...





Tuesday, July 26, 2016

Effective Vendor Oversight: A Fundamental Element of Drug Development


By Frances Grote, Practice Lead, Clinical Sourcing Advisory, ISG

Of all the potential drugs being developed today, it’s likely no more than five percent will make it to market. On top of this high failure rate, complex protocols and stringent regulatory requirements--while necessary to ensure safety and efficacy—have greatly increased the burden of process, documentation and data collection. With an industry-wide spend of nearly $50 billion a year on outsourced services, almost all BioPharma companies depend on vendors to conduct some of their most complex and sensitive development activities. The operational and clinical expertise of those vendors is crucial to success.

Clearly, both sponsors and vendors care deeply about getting the maximum value from these relationships. But value is not the same thing as cost. Financial analyses can only give you one part of the picture. Sponsors also need to take a hard look at what they’re investing in vendor oversight.

For starters, many sponsors struggle with helping their internal staff make the transition from study management roles to performing vendor oversight. The ability to oversee outsourced activities in a way that delivers optimal performance while minimizing risk requires an entirely different set of strategies and skills than running a clinical trial. And once a sponsor internal team has the right training, they’re still going to need the metrics and leading indicators to proactively identify risk and reliably predict timelines and costs. Without these tools there is no way of knowing if the value being achieved meets the objectives that drove the decision to outsource in the first place.






Monday, July 25, 2016

WATCH: Partnerships in Clinical Trials Highlights


Partnerships in Clinical Trials is the world's foremost event series for clinical development leaders and practitioners. This event draws 1100+ leaders from pharma, biotech & medical device companies, CROs, and third-party services providers in to network, learn, strategize and advance next practices in clinical trials across the globe.

Last year's event was a fantastic, with unique solution-oriented sessions designed to showcase real insights to foster real changes – unfiltered, unedited and unscripted. Plus, it was all under one roof – sessions, keynotes, roundtable discussions and exhibitors showcasing the latest and greatest clinical advancements.

A very big thank you to everyone who attended and participated. Did you make it into the highlight video? Try and spot yourself! And don't miss out on PCT 2016, October 5-7 in Boston, MA. Click here for more information about this year's event!




Friday, July 22, 2016

Ultra Rare Diseases and the Collaboration Between CROs & Pharma


At the last Partnerships in Clinical Trials in Boston, MA, we sat down with Mike Collins, VP of Global Clinical Operations at Alexion Pharmaceuticals for an interview. At last year's event, Mike presented a session "CRO and Pharma Collaboration to Meet the Need of Patients with Ultra Rare Diseases". Stemming from the topic addressed in his presentation, during this exclusive interview we asked Mike about ultra rare diseases, the treatment options, development of drugs, the research around these diseases and much more.

Every rare disease study is unique. Working with patients in rare diseases poses new and different challenges to both clinical trial sponsors and their CRO partners to ensure successful trial execution starting with the most critical factor – understanding the needs of the patient. Hear from Mike as he sheds light on how a sponsor and CRO can align efforts to successfully execute a global rare disease study.




Wednesday, July 20, 2016

Maximizing Sponsor/Provider Relationships for Longer-Term Success


Joining the Partnerships in Clinical Trials speaking faculty this October is Jason K. Casarella, SVP, Business Development & Marketing at Advanced Clinical. Jason was kind enough to sit down with the PCT team and address some of the major trends and the biggest challenges that are impacting the industry today, as well as how you can maximize sponsor/provider relationships for long term success.   




Monday, July 18, 2016

The Future of Clinical Trial Recruitment is Already Here



You would think from some of the discussions at this year’s DIA Annual Meeting in Philadelphia that the digital promise to clinical research – offering among other things, deeper patient insights, faster recruitment, greater retention and cheaper, quicker, more successful trials - was all a bit fanciful; an idea that would take decades to roll out.


Speakers at a number of different events (mainly from sponsor companies) noted the ethical, organisational and process hurdles to be overcome, including the need for much greater standardisation of data handling systems that study sites were required to use, for real progress to be made.

I was more encouraged, though, by other speakers and exhibitors at DIA who have seen the potential for innovative study design and operation, and are either implementing it themselves already or commissioning it from partners; from patient-friendly, online study materials, to web-based advertising, and relationship-building with patient advocacy groups – particularly those with an online presence. 





Friday, July 15, 2016

The Greatest Challenges Facing Clinical Research Development Today


Expert Opinion:
What is the greatest issue or challenge facing clinical research development today and how do you think it should be addressed?

"The single greatest challenge in the industry today is that the field has thought of itself as being commoditized" -Atul Butte, Director of the Institute for Computational Health Sciences, UCSF

The Partnerships in Clinical Trials team were able to sit down with many industry experts to get their professional opinion in regards to the greatest challenges facing clinical research development today. We were joined by;
  • Atul Butte, Director of the Institute for Computational Health Sciences, UCSF
  • Cathy Dawson, Director of Medical Scientific Affairs Group, Aesculap
  • Isan Chen, Chief Medical Officer, Mirati Therapeutics 
  • Jayne Gershkowitz, VP of Patient & Professional Advocacy, Amiscus
  • Mike Collins, VP or Global Clinical Operations, Alexion Pharmaceuticals
  • Gary Thompson, Senior Director of Data Sciences, Eli Lilly & Co. 




Monday, July 11, 2016

How Collaboration Between Stakeholders Will Transform Clinical Research


By April Schultz, Content Marketing Writer, Forte Research Systems

In the clinical research industry, communication between stakeholders is notoriously strained. Industry players such as sites, sponsors, CROs and patients often struggle to maintain adequate and effective communication, leading to strained relationships and ineffective clinical trial processes. Clinical research professionals have become increasingly aware of these roadblocks and are working to change the way the industry communicates. Transparency is now a buzzword heard at every industry event, including Vice President, Joe Biden’s recent Cancer Moonshot Summit.

While the need for greater transparency is apparent, some are unconvinced that the industry can change fast enough to achieve necessary levels of communication. To achieve transparency and gain greater efficiencies in clinical research, all stakeholders need to be on board and collaboration needs to be a key focus for the entire industry. Below are some key talking points that address this need for industry-wide cooperation.




Tuesday, June 21, 2016

Patient-led design is finally coming of age

What patients think does matter. The pharmaceutical industry has made great strides in accepting that. They have even gone as far as understanding how patient views can be taken into account in drug development.

Delegates at the recent industry event in London heard that what doctors think is NOT the same as what patients think. Five years ago, this conference would not have happened. The industry was sure that what doctors think was interchangeable with what patients think: “Why would we want to speak to patients?” was the common refrain.

It’s hard to think of another industry where the views of the user have so recently been ignored. It is partly because the pharmaceutical industry employs a lot of doctors, and doctors have typically held the patrician view that doctor knows best. It’s also because drug development is complicated: designing, planning and implementing complex clinical trials in multiple countries means it can take 10 years to get a drug to market. You have to be sure that doctors want it and that regulators are likely to accept the results when the dossier of evidence is submitted. So it is understandable that drug developers have been averse to adding another variable into the mix by asking the users – that’s the patients – what they want.

It is early days but there are signs of change in pharma land. Like most change, a cultural change has to come first. Helping to drive that change is the quietly-spoken but not to be under-estimated Iris Loew-Friedrich, Chief Medical Officer of UCB. When faced with internal objections from legal or compliance that they can’t produce a straightforward, patient-friendly, informed consent form, she simply says: “I won’t take no for an answer. Show me the path and find a way!” A 20-page, dense legal dossier simply won’t do.

Novartis is taking a top-down approach in tackling what it sees as an industry at breaking point due to inefficiencies. The dream of Novartis CMO and Global Head of Drug Development, Vasant Narasimhan is an entirely paperless study. Overcoming internal resistance to change is key: “Usually you get six to twelve months of complaining. Then people move on to something new to complain about.”

• Amgen is trying more tests at home or with a GP rather than at a trial site

• Pfizer is involving the patient’s GP during the referral process, paying for their time in consulting a patient’s medical records to check if suitable for a particular trial

• Merck has improved trial design thanks to patient advisory boards; the company is also advising patients of trial progress along the way eg how many enrolled so far

• Lilly, a leader in the area of trial education, expects to have lay summaries of trial results by Q1 2017; it also runs CoLabs where a trial simulation is held to see if it works in the real world ahead of a protocol being approved.


There was general consensus at the conference that the industry is very good at being negative about the next two years and terrible at envisaging the next 10 years. 2016 could see a step change.


About the author:

Julie Walters, Raremark, the Founder, is a contributing writer for the Partnerships in Clinical Trials conference who has over 20 years of experience in the digital healthcare sector, including time spent as a news reporter and news editor at Sky News, Reuters TV and Good Morning.




Monday, June 13, 2016

Building a Foundation for Partnerships with Patient Communities

By April Schultz, Content Marketing Writer, Forte Research Systems

In a recent article published on the Forte Clinical Research Blog I define and highlight the importance of community engagement in clinical research. The article describes the need for sites and sponsors to communicate and engage with patient communities and advocacy groups. Such engagement empowers patients to become stakeholders in the industry and forms collaborative partnerships built on mutual respect and trust. These partnerships also aid the industry’s efforts to make trial design and conduct more patient-centric by allowing patients to have more input on the clinical research process. It seems many research organizations see the value in engaging patient communities, but are either unsure how to begin a partnership or are using ineffective community engagement methods. To successfully involve patient communities in the clinical research process, it’s important to develop a solid foundation for your community engagement initiatives. This means determining how your organization will communicate with patient communities and defining their role in the clinical research process.



A Foundation for Community Engagement


While the foundation for your partnership may differ based on the needs of each patient community, you can form the groundwork of your engagement initiative using these five steps as a guide:


1. Set clear goals


Your community engagement efforts should meet the needs of the patients involved. To do this, it’s important to define goals for the partnership and provide a solid guide to achieving those goals. Communication is key to determining what is appropriate and beneficial for both parties. During the initial stages of your partnership, actively discuss the needs and wants of both parties and begin to outline feasible goals for everyone involved. Throughout the course of the partnership, regularly assess these goals and the steps that have been taken to achieve them.


2. Establish expectations for communication and involvement


Partnerships often work best when guidelines for communication and participation are established upfront between all parties. Clearly establish how your partnership with the patient community will function, who will be the main sources of communication and what resources are needed for an effective partnership.


3. Gain a better understanding of the community


Take the time to learn about the attitudes and practices of the patient community you partner with. Make an effort to understand the group’s culture, how they prefer to communicate and other practices or attributes that make the community unique. Knowledge of these characteristics can help foster a stronger and more personalized relationship between you and the patient community and may encourage more responsiveness from the group.


4. Promote transparency


In community engagement, transparency is a two-way street. Patient communities should be encouraged to provide candid, open contributions during discussion and community engagement events. In return, it’s important you keep the patient community updated on clinical trial progress. While regulations certainly limit transparency for some trial information, it’s still possible to provide information on trial outcomes, relevant enrolling studies and other updates on the disease area.


5. Uphold a long-term commitment


To gain the most benefit from partnerships with patient communities, and to build a trusting and open relationship, it’s essential that both parties maintain a long-term commitment to the initiative. Overtime, communication between both parties will continuously improve clinical research as a whole and support patient-centric clinical trials.



Catering to the Individual


As stated above, these principles can and should be flexible based on the needs and qualities of each patient community or advocacy group you partner with. Maintaining a quality partnership and making your clinical trials more patient-centric means adapting your engagement methods to the needs of the individual patient community.

This flexibility is essential to both strengthen your relationship with the patients involved and to help you meet the unique challenges of every patient community. For each community or advocacy group, the type and frequency of communication could differ and the need for sponsor/CRO provided training could vary. For small or new patient communities, administrative staff may be minimal and thus communication via email or digital means may be strained. For global patient communities, it’s important to be wary of the country restrictions on communications with patients and physicians, particularly online and social media content.

When establishing the groundwork for your community engagement efforts, be sure to take into account the unique needs of the group you’re working with and attempt to build a partnership that proves mutually beneficial and convenient.



References:

• https://www.hanc.info/cp/resources/Documents/Recommendations%202014%20FINAL%206-5-14%20rc.pdf
http://www.clinicalleader.com/doc/engaging-with-patient-advocates-to-improve-clinical-trials-0001?atc~c=771+s%3d773+r%3d001+l%3da&immediate=true



About the author:

April Schultz is the Content Marketing Writer at Forte Research Systems, a developer of clinical research software. In this role, she is responsible for the creation and direction of Forte’s educational materials such as blog articles, eBooks and webinars. She manages Forte’s content calendar, oversees content posted to the Forte Clinical Research Blog and works with presenters to host Forte’s monthly educational webinar series.




Building a Foundation for Partnerships with Patient Communities

By April Schultz, Content Marketing Writer, Forte Research Systems

In a recent article published on the Forte Clinical Research Blog I define and highlight the importance of community engagement in clinical research. The article describes the need for sites and sponsors to communicate and engage with patient communities and advocacy groups. Such engagement empowers patients to become stakeholders in the industry and forms collaborative partnerships built on mutual respect and trust. These partnerships also aid the industry’s efforts to make trial design and conduct more patient-centric by allowing patients to have more input on the clinical research process. It seems many research organizations see the value in engaging patient communities, but are either unsure how to begin a partnership or are using ineffective community engagement methods. To successfully involve patient communities in the clinical research process, it’s important to develop a solid foundation for your community engagement initiatives. This means determining how your organization will communicate with patient communities and defining their role in the clinical research process.



A Foundation for Community Engagement


While the foundation for your partnership may differ based on the needs of each patient community, you can form the groundwork of your engagement initiative using these five steps as a guide:


1. Set clear goals


Your community engagement efforts should meet the needs of the patients involved. To do this, it’s important to define goals for the partnership and provide a solid guide to achieving those goals. Communication is key to determining what is appropriate and beneficial for both parties. During the initial stages of your partnership, actively discuss the needs and wants of both parties and begin to outline feasible goals for everyone involved. Throughout the course of the partnership, regularly assess these goals and the steps that have been taken to achieve them.


2. Establish expectations for communication and involvement


Partnerships often work best when guidelines for communication and participation are established upfront between all parties. Clearly establish how your partnership with the patient community will function, who will be the main sources of communication and what resources are needed for an effective partnership.


3. Gain a better understanding of the community


Take the time to learn about the attitudes and practices of the patient community you partner with. Make an effort to understand the group’s culture, how they prefer to communicate and other practices or attributes that make the community unique. Knowledge of these characteristics can help foster a stronger and more personalized relationship between you and the patient community and may encourage more responsiveness from the group.


4. Promote transparency


In community engagement, transparency is a two-way street. Patient communities should be encouraged to provide candid, open contributions during discussion and community engagement events. In return, it’s important you keep the patient community updated on clinical trial progress. While regulations certainly limit transparency for some trial information, it’s still possible to provide information on trial outcomes, relevant enrolling studies and other updates on the disease area.


5. Uphold a long-term commitment


To gain the most benefit from partnerships with patient communities, and to build a trusting and open relationship, it’s essential that both parties maintain a long-term commitment to the initiative. Overtime, communication between both parties will continuously improve clinical research as a whole and support patient-centric clinical trials.



Catering to the Individual


As stated above, these principles can and should be flexible based on the needs and qualities of each patient community or advocacy group you partner with. Maintaining a quality partnership and making your clinical trials more patient-centric means adapting your engagement methods to the needs of the individual patient community.

This flexibility is essential to both strengthen your relationship with the patients involved and to help you meet the unique challenges of every patient community. For each community or advocacy group, the type and frequency of communication could differ and the need for sponsor/CRO provided training could vary. For small or new patient communities, administrative staff may be minimal and thus communication via email or digital means may be strained. For global patient communities, it’s important to be wary of the country restrictions on communications with patients and physicians, particularly online and social media content.

When establishing the groundwork for your community engagement efforts, be sure to take into account the unique needs of the group you’re working with and attempt to build a partnership that proves mutually beneficial and convenient.



References:

• https://www.hanc.info/cp/resources/Documents/Recommendations%202014%20FINAL%206-5-14%20rc.pdf
http://www.clinicalleader.com/doc/engaging-with-patient-advocates-to-improve-clinical-trials-0001?atc~c=771+s%3d773+r%3d001+l%3da&immediate=true



About the author:

April Schultz is the Content Marketing Writer at Forte Research Systems, a developer of clinical research software. In this role, she is responsible for the creation and direction of Forte’s educational materials such as blog articles, eBooks and webinars. She manages Forte’s content calendar, oversees content posted to the Forte Clinical Research Blog and works with presenters to host Forte’s monthly educational webinar series.




Wednesday, June 8, 2016

The Low Tech Approach to Recruitment (and Selling Your Car)

In my last post, social media was questioned for its potential efficacy in aiding recruitment efforts. Though I remain skeptical about the utility of outlets such as Twitter to drive significant improvements to research participation, earlier this week I found myself in an academic medical center with the same raised eyebrow… but this time around social media’s not so long lost cousin: the tear-off sheet.

Imagine the setting – a modern, bright and busy hospital lobby where I am pushing the button for the elevator. Right above the panel button? A tear-off sheet for a study at the hospital around diet. Every time I see a tear off sheet these days, I am either at the library or… the hospital. And what do I think of? The early 1980’s, waiting for food at our town's deli, reading the bulletin board to pass the time – music lessons, babysitting, items for sale.

But I digress… so after arriving up at the dermatology clinic for my son’s appointment on this particular day, we head into the exam room, door closes and… tear-off sheet: Do You Have Psoriasis? And since this sheet had a picture of psoriasis on it, my son was intrigued. What is this, how do you say it, who has this, does it hurt and so forth. Meanwhile, all I could think was… why is there a tear-off sheet, in a doctor’s exam room, where besides a medical professional there is also a computer running a multi-million dollar electronic records system?

Perhaps if my visit was for newly diagnosed psoriasis, I would have asked about the study after staring at the sheet for 20 minutes while I waited for my appointment. Or perhaps the doctor would have torn off the one-by-two inch piece of paper with a phone number on it and told me to call. Even thinking optimistically, it still struck me as so odd to be recruiting for a trial via paper, on a condition that is highly common in a dermatology clinic.

The “tear-off” approach to clinical trial recruiting seems so… transactional… when studies like this continue to show that patient attitudes towards clinical research tend to be at best uninformed (and at worst, fearful). It seems to me the best way to enhance recruitment is through the physician that already has the relationship with the patient – yet I admit that physicians are already pressed for time and balancing other patient demands. I can’t wait to hear what the experts at this fall’s conference have to say about the balance of self-identification for research versus physician engagement – and how technology, low and/or high, fits within.


About the author: Jennifer Crowley is a contributing writer for the Partnerships in Clinical Trials conference. When she is not working as a healthcare marketing and PR professional, Jennifer Crowley is mom to an eight year old son with cancer. His illness has largely driven her interests in patient advocacy, pediatric cancer research and personalized medicine. It's great to learn because knowledge is power!





Wednesday, April 20, 2016

Mobile Health: Exciting Technology for the Right Clinical Trial

By, April Schultz, Content Marketing Writer, Forte Research Systems

Partnerships in Clinical trialsThe clinical research industry is booming with new digital technologies and now, more than ever, the industry has the tools to make trials more patient-centric. In particular, the emergence of wearable and mobile health technologies have the potential to greatly advance patient-centricity in clinical trials through real-time data collection and participant engagement.

However, in order to maintain a truly patient-centric trial design, it’s important to make objective decisions about the use of mobile technology, with a study’s participant population in mind. As exciting as mobile health is, some technologies may impede the patient-centricity of a trial, making participation more difficult for some individuals.


How mobile health technology could revolutionize patient-centricity in clinical trials.


One of the most exciting capabilities of mobile health technology is the real-time data collection feature of some wearable devices and mobile apps. These features make data collection of everyday activities, such as exercise and sleep habits, more continuous and likely more accurate. Mobile apps allow participants to complete surveys in real-time, reducing recall bias. Patients can also self-track health-related items like blood pressure, diet, and more using commercial wearables or FDA-approved medical devices.

These mobile health capabilities could ultimately lead to a decrease in clinic visits or follow-up phone calls for participants, making it easier and more cost effective for people to participate in a clinical trial. It could also increase the scope of a trial by allowing individuals to participate from a greater distance, as travel requirements are reduced. This can lead to a more representative population by making it easier for people from rural areas to be involved in a study.

Participant engagement could also increase through the use of these technologies, as it’s now easier to communicate information and transmit surveys and other trial-related activities. If a participant has a trial-related question, it’s possible for her to check the mobile app and have the answer at her fingertips when needed, either through communication with study staff or in mobile documentation. A survey or activity could be transmitted and completed in real-time using the mobile health app, requiring little effort on the part of the participant. The participant can be continuously engaged with the study and provided the necessary information, making trial participation convenient and potentially more enjoyable.


Why mobile health should not be used for every clinical trial.


As described above, mobile health has a lot of potential in the clinical research space and could make the clinical trial experience much more patient-centric. However, these technologies may not be appropriate tools for every trial. It’s essential to be sure you're using tools that enhance the patient experience and ensure data integrity. For some patient populations, mobile health could prove detrimental. When determining whether mobile health is appropriate for your clinical trial, evaluate and characterize your participant population and their relationship with digital technology. Also take into account the feasibility of a mobile health study and assess whether you have the necessary resources to provide the best participant experience. Answer these key questions when considering mobile health for your study:


What is the age range of my participant population?


While younger generations are very adept with technology, seniors may struggle to use mobile health applications or devices. Using mobile health for an older demographic may require research staff to provide extra training. Such trial design could also inconvenience an older patient population as it may require them to perform atypical tasks and significantly alter the way they function throughout the day.


Do the majority of my participants have smartphones?


The demographics of your participant population, including age, financial status, location, as well as a variety of other factors, could influence whether they have access to a smartphone. If some of your participants don’t have smartphones, will you provide them the necessary technology? This could prove logistically difficult and limit the amount of eligible study participants in your target population.

Will my study use apps that participants already use? (e.g. Fitbit, MapMyRun, MyFitnessPal, other diary applications)

If your study requires you to create a new app, it could be difficult to find the resources and expertise to properly develop this technology. It may also require extra effort to encourage study participants to use the new application. Employing an application that is already widely used could reduce the amount of change required in a participant’s daily behavior, making the trial more convenient.


Is real-time data truly necessary for the benefit of my study?


The potential of mobile health and real-time data is exciting and it’s tempting to take advantage of the technology regardless of whether your study will truly benefit from its use. Critically evaluate whether the costs of using mobile health (such as those listed above) are worth the benefits of real-time data. If the benefits fall short, it may be best to opt-out of mobile health and design a trial better suited to the needs of your study and participants.

While mobile health technology could revolutionize how the clinical research industry conducts clinical trials, patient-centricity relies on the industry’s focus on building a positive participant experience. Regardless of whether mobile health is incorporated into study design, it’s essential to design each trial with the participant’s best interests in mind.



Bio:
April Schultz, a contributing writer for the Partnerships in Clinical Trials conference
April Schultz is the Content Marketing Writer at Forte Research Systems, a developer of clinical research software. In this role, she is responsible for the creation and direction of Forte’s educational materials such as blog articles, eBooks and webinars. She manages Forte’s content calendar, oversees content posted to the Forte Clinical Research Blog (http://forteresearch.com/news/) and works with presenters to host Forte’s monthly educational webinar series.





Wednesday, April 6, 2016

Clinical Trials and Patient Recruitment: To Tweet or not to Tweet

Patient recruitment for clinical trials on social mediaLast December, this study showing that participation in oncology trials is basically abysmal made national headlines and helped create an interesting news juxtaposition – on one hand, a cancer moonshot is in the works, on the other, less than one in five patients today participates in vital, available research.

Enter Twitter, stage right. In an effort to identify possible novel approaches to improve recruitment results for not just cancer trials but all types of medical research, social media started to garner interest on the heels of those headlines. I personally found this suggestion both interesting and puzzling.

I am a Twitter user – and mother to an 8-year-old son with cancer who is currently enrolled in his third clinical trial (he’s doing great, btw). Prior to reading the Medscape piece, I would have never thought twice about Twitter as a source of vital medical information. For me, Twitter is a way to quickly catch up on current events happening locally, politically and around the pediatric cancer community.

So what is my opinion on Twitter as a trial recruitment source? Meh. First of all, consider who uses Twitter – according to Pew Research Center about 23% of all adult internet users, and a fifth of the entire adult population, uses Twitter. In the US, there are about 65 million Twitter users; usage is highest among urban residents, adults under 50 and people in upper-income brackets. Impressive certainly since the network is only ten years old, but how does its core demographic map to the types of patients that could benefit from a clinical trial?

I am not a scientist nor mathematician so I cannot answer my own question beyond the obvious – a lot of opportunity to reach patients, but what does that really mean because the medium is not the message. There is how to get the right trial opportunity in front of the right patient… and then how to spur action.

The context to social media usage as one experiences medical challenges is extremely nuanced. I belong to a community of cancer moms that will embrace social media for access to support via other families and communal knowledge, and will as quickly put it down when reality – that of others including full heads of hair and easily reached milestones – is emotionally too much.

So clearly I believe social media has a place in disseminating useful information but for Twitter or any social media channel to help with clinical trial recruitment, there is much work to be done. Where to start? How about by re-branding the term which far too many associate with “experimental medicine” or worse yet, “beyond help.” After all, what would you rather sign up for, a trial or an opportunity? If someone were to describe your personality as “clinical,” would that please you? When I tell people that my son is on a clinical trial, I often get a sad face – and yet I wholly credit our decision for his amazing progress.

All this to simply say, it’s fabulous that there is open dialogue about how to expand access to new treatment options for patients that could benefit by way of improved outcomes, less invasive therapies and more manageable side effects. Social media has a role, but it’s no silver bullet, particularly the sound byte laden Twitter. In fact, using Twitter as a lever in trial recruitment sounds like an interesting research study in and of itself to identify the most engaging sources and responsive populations. Hmmm now how to start recruiting?


About the author: When she is not working as a healthcare marketing and PR professional, Jennifer Crowley is mom to an eight year old son with cancer. His illness has largely driven her interests in patient advocacy, pediatric cancer research and personalized medicine. It's great to learn because knowledge is power!





Clinical Trials and Patient Recruitment: To Tweet or not to Tweet

Patient recruitment for clinical trials on social mediaLast December, this study showing that participation in oncology trials is basically abysmal made national headlines and helped create an interesting news juxtaposition – on one hand, a cancer moonshot is in the works, on the other, less than one in five patients today participates in vital, available research.

Enter Twitter, stage right. In an effort to identify possible novel approaches to improve recruitment results for not just cancer trials but all types of medical research, social media started to garner interest on the heels of those headlines. I personally found this suggestion both interesting and puzzling.

I am a Twitter user – and mother to an 8-year-old son with cancer who is currently enrolled in his third clinical trial (he’s doing great, btw). Prior to reading the Medscape piece, I would have never thought twice about Twitter as a source of vital medical information. For me, Twitter is a way to quickly catch up on current events happening locally, politically and around the pediatric cancer community.

So what is my opinion on Twitter as a trial recruitment source? Meh. First of all, consider who uses Twitter – according to Pew Research Center about 23% of all adult internet users, and a fifth of the entire adult population, uses Twitter. In the US, there are about 65 million Twitter users; usage is highest among urban residents, adults under 50 and people in upper-income brackets. Impressive certainly since the network is only ten years old, but how does its core demographic map to the types of patients that could benefit from a clinical trial?

I am not a scientist nor mathematician so I cannot answer my own question beyond the obvious – a lot of opportunity to reach patients, but what does that really mean because the medium is not the message. There is how to get the right trial opportunity in front of the right patient… and then how to spur action.

The context to social media usage as one experiences medical challenges is extremely nuanced. I belong to a community of cancer moms that will embrace social media for access to support via other families and communal knowledge, and will as quickly put it down when reality – that of others including full heads of hair and easily reached milestones – is emotionally too much.

So clearly I believe social media has a place in disseminating useful information but for Twitter or any social media channel to help with clinical trial recruitment, there is much work to be done. Where to start? How about by re-branding the term which far too many associate with “experimental medicine” or worse yet, “beyond help.” After all, what would you rather sign up for, a trial or an opportunity? If someone were to describe your personality as “clinical,” would that please you? When I tell people that my son is on a clinical trial, I often get a sad face – and yet I wholly credit our decision for his amazing progress.

All this to simply say, it’s fabulous that there is open dialogue about how to expand access to new treatment options for patients that could benefit by way of improved outcomes, less invasive therapies and more manageable side effects. Social media has a role, but it’s no silver bullet, particularly the sound byte laden Twitter. In fact, using Twitter as a lever in trial recruitment sounds like an interesting research study in and of itself to identify the most engaging sources and responsive populations. Hmmm now how to start recruiting?


About the author: When she is not working as a healthcare marketing and PR professional, Jennifer Crowley is mom to an eight year old son with cancer. His illness has largely driven her interests in patient advocacy, pediatric cancer research and personalized medicine. It's great to learn because knowledge is power!





Clinical Trials and Patient Recruitment: To Tweet or not to Tweet

Patient recruitment for clinical trials on social mediaLast December, this study showing that participation in oncology trials is basically abysmal made national headlines and helped create an interesting news juxtaposition – on one hand, a cancer moonshot is in the works, on the other, less than one in five patients today participates in vital, available research.

Enter Twitter, stage right. In an effort to identify possible novel approaches to improve recruitment results for not just cancer trials but all types of medical research, social media started to garner interest on the heels of those headlines. I personally found this suggestion both interesting and puzzling.

I am a Twitter user – and mother to an 8-year-old son with cancer who is currently enrolled in his third clinical trial (he’s doing great, btw). Prior to reading the Medscape piece, I would have never thought twice about Twitter as a source of vital medical information. For me, Twitter is a way to quickly catch up on current events happening locally, politically and around the pediatric cancer community.

So what is my opinion on Twitter as a trial recruitment source? Meh. First of all, consider who uses Twitter – according to Pew Research Center about 23% of all adult internet users, and a fifth of the entire adult population, uses Twitter. In the US, there are about 65 million Twitter users; usage is highest among urban residents, adults under 50 and people in upper-income brackets. Impressive certainly since the network is only ten years old, but how does its core demographic map to the types of patients that could benefit from a clinical trial?

I am not a scientist nor mathematician so I cannot answer my own question beyond the obvious – a lot of opportunity to reach patients, but what does that really mean because the medium is not the message. There is how to get the right trial opportunity in front of the right patient… and then how to spur action.

The context to social media usage as one experiences medical challenges is extremely nuanced. I belong to a community of cancer moms that will embrace social media for access to support via other families and communal knowledge, and will as quickly put it down when reality – that of others including full heads of hair and easily reached milestones – is emotionally too much.

So clearly I believe social media has a place in disseminating useful information but for Twitter or any social media channel to help with clinical trial recruitment, there is much work to be done. Where to start? How about by re-branding the term which far too many associate with “experimental medicine” or worse yet, “beyond help.” After all, what would you rather sign up for, a trial or an opportunity? If someone were to describe your personality as “clinical,” would that please you? When I tell people that my son is on a clinical trial, I often get a sad face – and yet I wholly credit our decision for his amazing progress.

All this to simply say, it’s fabulous that there is open dialogue about how to expand access to new treatment options for patients that could benefit by way of improved outcomes, less invasive therapies and more manageable side effects. Social media has a role, but it’s no silver bullet, particularly the sound byte laden Twitter. In fact, using Twitter as a lever in trial recruitment sounds like an interesting research study in and of itself to identify the most engaging sources and responsive populations. Hmmm now how to start recruiting?


About the author: When she is not working as a healthcare marketing and PR professional, Jennifer Crowley is mom to an eight year old son with cancer. His illness has largely driven her interests in patient advocacy, pediatric cancer research and personalized medicine. It's great to learn because knowledge is power!





Monday, February 22, 2016

Earn a FREE Pass to Partnerships in Clinical Trials 2016 - Become a Guest Blogger! | Boston, MA

Logo for the IIR's (Informa) Partnerships in Clinical Trials 2016



Partnerships in Clinical Trials 2016
October 5-7, 2016
Boston Convention and Exhibition Center
415 Summer St.
Boston, MA 02210 

Earn a complimentary all-access pass to Partnerships in Clinical Trials 2016 by serving as a Guest Blogger at the event. As a Guest Blogger, you’ll have access to the event’s comprehensive agenda attracting the leaders in clinical trials from around the world, right in Boston, MA in October.

We are looking for an industry expert with interest in the following topics:


• Data Standardization & Strategic Applications for Analytics; 
• Data Transparency;
• Patient Engagement & Recruitment;
• New Engagement Models in Patient/Site Interactions;
• Operational Implication of Risk Sharing Collaborations;
• Efficiencies in Strategic Partnerships;
• Partnering with Payers in Clinical Development 
• Innovative Outsourcing Strategies and Models- Small Biotech's/Small- Mid Sized

• Risk-Based Approaches in Clinical Development 
• Successful Interactions with Regulatory Agencies & Expedited Drug 
• Implementing Disruptive Technologies for Clinical Development  
• Clinical Operations in Global Trials 
• Site Selection in Global Trials
• Patient Recruitment in Global Trials

....and who would like to learn innovative strategies to navigate the transforming clinical landscape.

The premise is to provide PCT 2016 related blog posts (300-500 words), whitepapers, and overall light coverage of the event.


What you get is:


• You'll get a free all-pass to the annual Partnerships in Clinical Trials conference (valued at $2,995);
• Access to an extensive learning activities;
• Exclusive access to a networking community in the industry of your interest!


Apply today by sending your name, title, company, short biography and links to your blog or writing samples, along with a few sentences about why we should choose you to the Guest Blogger for PCT 2016 to Ksenia Newton at knewton@iirusa.com. We will review your submission and contact the chosen Guest Bloggers directly with more details.

We hope to have you join us in Boston!

*Guest Bloggers are responsible for their own travel and lodging. 

Subscribe to our blog or follow us on Twitter:  @PartnershipCROs and #PCTUS16 






Friday, November 27, 2015

Partnerships or Operating Models to Empower Delivery?

Chris Rull, Vice President, Service Provider Management Merck 

Over the past 5+ years, there has been a huge evolution in the strategic partnerships used to bring new therapies through clinical trials. I’ve witnessed this evolution from both sides of the partnership – working both within CROs and most recently within Merck..

One of the key challenges that sponsor companies face is in identifying the partnership characteristics the sponsor organisation needs most and being able to truly define their core and non-core competencies as desired.. Accomplishing this requires internal investment and analysis of organisational strengths and weaknesses. Through this process,  existing core competencies need to be identified along with opportunities to invest in maintaining and growing those competencies.

One of the most under-rated areas of partnership launch is Change Management, despite all the discussion around it.  Both parties need to be willing to invest, change and evolve with the partnership and make use of the expertise and experience that each bring. This of course requires the ability to really digest the cultural DNA and impact the organizational behaviours

Expectation alignment is also crucial - if internal strategy and external provision are not aligned, then no matter how strong the two partners are, challenges will arise.

And this draws back to the real goal of a true clinical development partnership – to bring new therapies to market and return efficiency to all parties. To do this, you have to achieve close alignment. All parties and players have to understand core strategy and the operating model in order to build a successful partnership.

Also essential is creating an environment within the partnership that empowers the functions accountable for the work. And you need a governance structure that is accountable and empowering and does not replace the functions that you are trying to optimize in the new structure.

In my opinion, one of the biggest red herrings is that many sponsors create or introduce strategic partnership as a result of external pressures that are misaligned to the above.  In these instances, regulatory reaction stands in the way of successful partnerships. Most of the regulations that relate to partnerships are self-imposed. Yet, if we spend the time with the regulations, they actually provide a great deal of flexibility to deliver your vision and purpose in a strategic partnership. 

In order to overcome these challenges, we have recently reorganized to deliver better service provider management. As head of this new function, my role is to provide clarity over who owns a relationship and ensure the relationship is managed effectively.


I’ve been a big believer in forums such as PCT-Europe for a long time; they are critically important as they bring people together from across the industry to discuss the issues in a very open and honest manner.




Friday, November 20, 2015

Data, transparency and the new EU regulatory environment

Thursday at the Partnerships in Clinical Trials meeting 2015 saw a panel of experts discussing questions posed by delegates on all manner of topics, such as the concept of "patient centricity" and industry's preparedness for the change, and a very interesting session on the implications of the EU Clinical Trials Regulation.

As I mentioned before, "patient centricity" is at the heart of this year's conference, and it certainly caught a lot of people's attention on Thursday morning. Panellists talked about technology, mobile devices, and new ways of capturing data, and suggested that we have only just begun to scratch the surface here. They painted a future where Google, Apple and the like will be the enablers of such technological advances, with patients monitoring their vital signs at home and conversing with their physicians by video and teleconference, rather than having to visit the clinic. After all, some patients may live a long way from the clinic and find it hard to come in as often as they would like.

But while being a homebird may suit some patients taking part in clinical trials, others will miss the chance to take some time out, the "human touch" of meeting their doctor face to face, the feeling of actually talking to someone properly rather than through an e-medium of some sort.  Probably the end result will be some combination of the two in differing proportions, with technology being seen as an adjunct - if a major one – to the current ways of doing things.

In any case, the patient will take a greater role in clinical trials, whether he or she likes it or not. Patients know best what is going on with themselves, declared Prof Brendan Buckley, CMO at ICON in Ireland. Patients, he said, would act as "data providers, with ownership of the process." "The idea of the patient as sub-investigator will be an important factor in the coming years, allowing us to better handle the very significant increase in data flow that we will have."

But he sounded a note of caution about moving too fast, suggesting that proper partnerships and joined up thinking were a prerequisite for true patient centricity, and this isn't happening now. For example, one CRO gets the data, another one gets the labs, and so on, and this makes it difficult to coordinate the various activities in order to achieve the sought-for patient centricity. What is needed is more partnership between CROs and pharma firms, so that the patient is prioritised. If outsourcing is done piecemeal it will be impossible to pursue this agenda, Buckley noted.

"Don’t get carried away with idealism," he cautioned. "There is a fundamental problem about how outsourcing happens – if the CRO gets the whole deal, and the full service process, there is some chance of advancing that agenda, but mostly outsourcing is technical and goes trial by trial."
It was noted that it's important to ensure that the protocol is well thought out, which apparently does not happen as often as it should. Some sponsors, it was suggested, put far too much into their protocols, and CROs need to make sure they are lean and uncomplicated.

And of course, again, don't forget the patient – or the regulator. The regulator's role is key here: companies are used to working to what regulators require in their guidelines. But in future, the regulators will increasingly want to know this: did you talk to the patients, did you ask them what they really need? And it's not only the regulators that have this in mind - the payers do too. If you have strong patient input, it will make your payer negotiations easier.

Which all goes to show that a joined-up approach to patient involvement, with continuous consultation, collaboration and co-ordination among all the key players, is the  way forward.

One of the afternoon sessions managed to throw some light on the less well-known aspects of the new EU Regulation that will take the European clinical trials scene by storm in a couple of years' time.

The session featured a very interesting presentation by Marine Dehlinger-Kremer of CRO SynteractHCR in Germany, who explained the many far-reaching changes that the Regulation will bring, not least the clinical trials portal and database, a single application to conduct a trial, and a great deal more transparency of trial data. As you may know, the application of the Regulation's provisions has been postponed from a notional mid-2016 to nearer the end of 2017, mainly because of the complexity of testing out the portal and database and undoubtedly a myriad other technical niceties.

Dehlinger-Kremer delved into some of the more technical and procedural changes brought posed by the Regulation, such as greater flexibility of monitoring (light or heavy depending on the nature and aim of trial), and the requirement for the sponsor to evaluate to the extent and nature of monitoring – which she said opens the way to risk based monitoring (RBM).

She also pointed out that failure to abide by the new transparency requirements would incur substantial penalties, although we don’t know yet what kind of sanctions the member states will be able to impose in case of non-compliance.

This was fertile hunting ground for Lawyer Peter Bogaert of Covington and Burling in Brussels, who keeps a very close eye on EU regulatory developments and has been known to represent the odd pharmaceutical company before the Court of Justice of the European Union.

He said that there would be a number of challenges with the implementation of the Regulation. For example, the new concept of a "low intervention trial", which he suggested could inadvertently lead to more off-label use.

A low-intervention trial according to the new legislation is a low-risk trial using an approved drug, for example, and with some administrative simplification with regard to informed consent, monitoring, damages, accountability, and so on. The criteria for such a trial are that you use the drug either in accordance with its approved labelling, or based on published scientific evidence on its safety and efficacy.

But if you apply for low-intervention status, the member state may have to confirm that there is indeed such scientific evidence or some existing treatment protocols that support this use. In this way, it becomes formalised, "which in some way is ratifying off-label use", Bogaert declared.

So, given that some member states are looking at greater off-label use, for example for economic reasons (as is happening in France and Italy with Roche's Avastin in wet AMD), "this will bring another dynamic because you could end up with more off label uses that are considered to be supported by scientific evidence," Bogaert noted. This is a completely separate question from clinical trials, but it could have wide ramifications, he added.

Something that is very germane to clinical trials is the amount of transparency the Regulation will bring to trial data, via the requirement for all studies to be registered and their results reported on the publicly accessible database.

The arguments about the benefits or otherwise of such openness have been well rehearsed. One is the assertion that miscreants might misappropriate the data for their own nefarious ends. The topic surfaced again at the discussion on Thursday, with suggestions that some companies in Latin America had used data released by the EMA to gain approval of their own drugs. Just how this would work is not clear (do you just cross out the originator product's name and insert your own?), but I'm willing to be convinced by some concrete examples.

Another argument leveled against the wider release of trial data is that it could defeat the wider objective of the new Regulation, which is to make the EU more attractive as a site to run clinical trials. Will fear of their data being released wholesale to all and sundry (it won't, or at least there will be safeguards in place to protect truly commercially confidential information) lead companies to flee Europe in droves? That remains to be seen.

What is more likely is that there will be knock-on transparency effects elsewhere. Noting that the EU is the first to ask for this level of transparency, Chiesi Farmaceutici's Antonio Ferrari thought the US and even the emerging markets might soon follow suit. "The US has started with its Sunshine Act, and its next steps will be transparency European style", he declared. Watch this space.

There was at least agreement that the new portal and database could do pharma firms a lot of good, given that it allows a single trial application for the whole of the EU and is also the conduit for inspection reports and trial results; moreover it will have a very nice dedicated workspace where the  member states and applicants can exchange information. 

Bogaert said the Regulation was, generally speaking, an efficient tool for ensuring the EU legislation on clinical trials was as strong as it could be, and that it would address many of the shortcomings of the clinical trials Directive it is replacing.

For those who are interested in the constantly changing EU clinical trial landscape, the hard work of getting the portal and database system up and running is now under way, and user acceptance testing is expected to begin in February 2016. Once that is done the system must be audited to ensure it is fit for purpose, a process that is expected to start around November and last until March 2017. Once the system has been given the all clear, the verdict will be published in the Official Journal, possibly in mid-year, and the whole thing will kick off six months later – ie, around the end of 2017.


It may be two years away, but that's not a long time where a project of this kind is concerned and you'll need to take time to ensure your IT systems and your thinking are up to speed. The advice to pharma companies and CROs? Start getting to know the system now. Many of your competitors already have.