Wednesday, April 26, 2017

Oxford Debate: Pharma using CROs vs not outsourcing clinical trials

Do pharma & biotech companies need CROs or is it better not to outsource clinical trials at all? In recent years, partnerships and outsourcing have grown rapidly in popularity, promising cheaper, faster, more successful trials. However, there are still plenty of challenges to be overcome and for some, these challenges are so numerous that they outweigh the benefits of such collaborations.

At Partnerships in Clinical Trials Europe 2016 four leading drug development professionals debated this vital question with an audience vote before and after. Watch the arguments above (or watch it here) and find out if they managed to sway an audience firmly behind the benefits of outsourcing.

Partnerships and Collaborations: Forming Alliances That Last is one of four streams at T3: Trials, Tech and Transformation on May 11-12 in Orlando, Florida. Use the exclusive code T3BLOG17 to save $200 on the cost of a pass. Find out more here.

Friday, April 21, 2017

Ask the Experts: Are strategic partnerships in clinical trials living up to what they promised?

There was great hope in the clinical outsourcing world around strategic partnerships, but are they living up to their promise? We exclusively spoke to five leading clinical trial professionals about their views on how well collaborations are working and where they can still improve.
'How well they work really depends on how committed the individual partners are and what they see as the benefits, as well as how hard they really work collaboratively, to share information.' Susan Windham-Bannister, President and CEO of Biomedical Growth Strategies 
'If a company changes its strategic partner three times in five years, you start questioning whether that is a strategic partnership.' Nikola Strumberger, Clinical Operations Director at OptimaPharm 
'Strategic partnerships are a great idea with a way to go.' William Tannenbaum, Co-Head of Technology Transactions Practice at Arent Fox
Watch the full exclusive interviews above or here.

Partnerships and Collaborations: Forming Alliances That Last is one of four streams at T3: Trials, Tech and Transformation on May 11-12 in Orlando, Florida. Use the exclusive code T3BLOG17 to save $200 on the cost of a pass. Find out more here.

Tuesday, April 18, 2017

How Artificial Intelligence is revolutionising patient compliance

As a Senior Director of Clinical Science, William Jacobson is responsible for driving strategy for global clinical development at Takeda. At T3: Trials, Tech and Transformation Jacobson is speaking on the intriguing topic of how Artificial Intelligence can be used to improve subject compliance. We caught up with him on the tricky issue of compliance and how technology is helping meet the challenges.

What are the current issues with subject compliance during clinical trials?

WJ: ‘Compliance with investigational product use in a clinical trial is essential if one is to determine the true safety and efficacy profile of that product, whether in comparison to placebo or an active comparator. Typical means of compliance, historically, have been self-report and pill count. However, these have repeatedly been demonstrated to be unreliable, frequently overestimating the degree of compliance - pill counts for example routinely indicate levels of adherence above 95% across therapeutic areas.

Over the years a number of methodologies have been developed to increase our accuracy in determining compliance, as well as the level of compliance in clinical trials. In general though, they have not been particularly successful, with compliance often not determined until the end of the trial, at which point it is far too late to intervene in a positive manner.

Tuesday, April 11, 2017

Using collaboration and partnerships to accelerate clinical trial advancement

by Sarah Iqbal

Advancements in medical research have been critically important for the improvement of healthcare. They have helped progress in prevention, care, and treatment of people living with diseases. This progress could not have been made without the participation of not only physicians and patients, but patient advocates and support organizations as well.

However, running a clinical trial study is an arduous and complicated task.

Many issues still plague the clinical research industry such as low patient participation in clinical trials, patient diversity, patient burdens and consent forms. An increasingly important challenge is being created as organizations conducting trials use multiple disconnected methods to manage them. The data generated from these methods is stored in a proliferation of disparate data silos that have limited collaboration, making it difficult to do cross-query. In turn, this can lead to the creation of disconnected reports, which cannot provide a comprehensive view of the trials. Although organizations are data-rich, the current scenario of dispersed data silos causes immature information consumption. So, it becomes difficult to monitor clinical trials and proactively address quality issues.

Wednesday, April 5, 2017

REPORT: Technological Innovation in Clinical Trials 2017

Following a survey in partnership with SCORR Marketing of our global database of clinical trial professionals, we can now reveal the results. This report reveals unique insights into the awareness, perceptions and implementation of technological innovations in the drug development industry.

Based on 261 responses representing pharma, CROs and service providers split across North America, Europe and Asia, the exclusive report focuses on big data, cloud technology for EMRs, mHealth and patient-centricity.

The fascinating results provide a ‘state of the industry’ look at where these technologies are and where they are going, allowing professionals in the health sciences industry to better anticipate changes in their workplace.

Friday, March 31, 2017

'We really have to take out the complexity that has been over-engineered into clinical trials' - Rob DiCicco, VP at GSK

We spoke to Rob DiCicco, Vice President of Clinical Innovation & Digital Platforms at GSK, on the hottest topics in clinical trials and how he sees them changing in the next year.

Speaking exclusively at Partnerships in Clinical Trials Europe 2016, DiCicco explores:
  • - Patient-centricity: 'We need an end-to-end strategy for patient engagement... If we ask to monitor them 24/7 over the course of a clinical trial and ask them to share all kinds of data, then we owe it to them to get them their trial results in a timely fashion.'
  • - Technology: 'The application of Big Data analytics ought to inform the development of clinical trial protocols... and help to drive decision making to streamline trials.'
  • - Challenges: 'We really have to take out the complexity that has been over-engineered into clinical trials.'
  • - Changes in 2017: 'I think you'll see technology companies try to evolve things that look like Electronic Health Record connectors.'
Watch the full interview above or here.

Technology and patient-centricity are key topics at T3: Trials, Tech and Transformation on May 11-12 in Orlando, Florida. Register today and use the exclusive code T3BLOG17 to save $200 on a two-day pass. Find out more here.

Wednesday, March 29, 2017

T3: Trials, Tech and Transformation - Do you qualify for a free pass?

We would like to invite you to attend T3: Trials, Tech and Transformation on May 11-12, 2017 in Orlando, FL.

Knect365 is hosting a limited amount of complimentary registrations for an exclusive group of professionals. To provide an executive-level discussion and enable you to network with your peers, we strictly limit these passes to senior leaders from pharmaceutical, biotechnology and medical device companies. If you think you may qualify for a complimentary pass, please complete this form and we will be in touch soon.

This launch event will provide a two-day, 4-track agenda focused on the most pressing issues that you and your organization are facing.
  • - The Next Wave of Clinical Innovation
  • - Partnerships and Collaborations: Forming Alliances That Last
  • - Patients as Partners: How to Ensure You Are Putting the Patient First
  • - Partnering with Niche CROs, Biotechs and SMEs
Visit the website for the full agenda.

Speakers including Jeff Sherman, Executive Vice President, R&D and Chief Medical Officer at Horizon Pharma, Niven Narain, President, Co-founder and CEO at BERG Health, Maneesh Shrivastav, Director of Market Development and Clinical Trial Partnership at Medtronic Diabetes, and others will discuss a range of topics:
  • - New Partnerships, New Innovations, New Processes: What Can We Learn from the Past 12 Months?
  • - The Future of Clinical Trials: Rethinking the R&D Clinical Process
  • - Advances of Mobile Health and Clinical Technology (i.e., Wearables, Clouds, etc.) and What That Means for the Clinical Trials Sector?
  • - The Adoption and Implementation of an Artificial Intelligence Technology to Track and Improve Subject Compliance During Clinical Trials
  • - ICH E6 Addendum: Risk-based Monitoring: What Will This Mean for Clinical Trials?
  • - Learn from Rare and Orphan Diseases: Moving Away from Traditional Drug Development and Putting the Patient First
  • - Patient Centricity: Practical Tips for Involving the Public in Research Design and Delivery

Tuesday, March 28, 2017

How Big Data is shaping the smart hospitals of the future

ClinTech Month

As CEO of Farrer Park Hospital in Singapore, Dr. Timothy Low sees the complex as a no less than a 'fresh solution to healthcare'. Made up of a 5* hotel, a multi-specialty hospital and a specialist medical center, technology is used to connect every aspect of the patients' stay, right down to the patients' digital food menu linking to their EHRs.

In this exclusive interview from Biotech Week Boston 2016, he explores the future of smart hospitals and the use of Big Data in clinical trials.

This post is part of ClinTech Month - explore more here.

The Next Wave of Clinical Innovation is one of four streams at T3: Trials, Tech and Transformation on May 11-12 in Orlando, Florida. Register today and use the exclusive code T3BLOG17 to save $200 on a two-day pass. Find out more here.

Tuesday, March 21, 2017

'We need to do better job of defining patient-centricity' - Virgil Simons, founder The Prostate Net

For Virgil Simons, the patient is central to everything in drug development, which is hardly surprising for the founder and president of The Prostate Net and Prostate Net Europa - a 'non-profit patient education and advocacy organization dedicated to prostate cancer victims and their caregivers'.

Speaking at Partnerships in Clinical Trials Europe 2016, he explains that at the most basic level, the industry as a whole needs to do a 'better job of defining patient-centricity'. Through his work, Simons attempts to get the pharma industry to 'understand the role of patient-centricity from initial drug development, to clinical trial recruitment initiation, to downstream care. The problem is we talk a lot about it, but we don't really know how to do it.'

Friday, March 17, 2017

What does disruptive innovation mean to the clinical trials industry?

We asked many clinical trials professionals from pharma, CROs, academia, and non-profits about what disruptive innovation means to the clinical trials industry.

Hear these exclusive insights by watching the video below.

To learn more about what disruptive innovation holds for the clinical trials industry, join us at T3: Trials, Tech and Transformation in Orlando, FL this May. Save $200 with the VIP code T3BLOG17 | Click here to learn more.

Tuesday, March 14, 2017

What do clinical stakeholders need to think about when wanting to ‘do digital’?

ClinTech Month

The opportunities for organisations and stakeholders using digital technology such as mHealth in the clinical setting are growing rapidly. Products such as Apple ResearchKit, Health Kit and Google Fit, and Microsoft’s HealthVault are all providing wider access to valuable consumer health data gathered from a variety of sources, including wearables and hardware sensors.

This article explores what technologies exist to enable mobile applications to interact with cloud servers and how these technologies can be deployed.

Friday, March 10, 2017

The Primary Issues of Data Ownership

Big data has been one of the hottest buzzwords across all industries over the last few years and that doesn't seem to be changing anytime soon. Generally speaking, big data refers to large data sets that are to be analyzed to reveal patterns, trends, and associations that relate human behavior/interactions.

Pharma and biotech companies are not the first to this space and there is a lot that can be learned from other industries and those who have gone before, especially in regulated industries. William Tannenbaum, Co-Head of Technology Transactions Practice at Arent Fox LLP sat down with us to explore many of the major issues surrounding data ownership, best practices, privacy, and how the pharma/biotech industry can learn from other companies who have already been through this data revolution.

Watch the full interview with William Tannenbaum above to hear his perspective on these key issues and how they relate to our industry;
  • What can companies in pharma/biotech learn from companies in other industries regarding data practices?
  • Regarding data practices, what differentiates best practices from best-of-breed?
  • What are the primary issues around data ownership that companies need to consider? How should companies address these issues?
  • Privacy is obviously another key consideration. What are the issues here around privacy and what do companies need to think about?
At the upcoming T3: Trials, Tech and Transformation on May 11-12 in Orland, FL - The next wave of clinical innovation is one of the conference streams, where we will dive into clinical trials data management, analysis, and more. Register today and save up to $600 off standard rates with the VIP code T3BLOG17. Rates increase Friday, 3/17. Learn more here.

Wednesday, March 8, 2017

Women in pharma

International Women's Day

With the world celebrating International Women’s Day, we take a look at women in pharma.

Despite being set to become Big Pharma’s first female CEO, Emma Walmsley at GSK doesn’t see her gender as a major issue: ‘I’ve never primarily defined myself by my gender. I’ve been lucky enough to always work for companies or in countries where being female hasn’t limited or restricted me.’

However, the numbers suggest there is still some way to go before equality in pharma. Prior to Walmsley’s appointment, none of the world’s top 25 drugmakers were led by a woman, and less than 3% of new pharma CEO positions globally were given to women in 2015.

At Boston Biotech Week last year we spoke to President and CEO of Biomedical Growth Strategies Susan Windham-Bannister about the lack of gender diversity in Life Sciences and why organizations should be trying to improve.

Tuesday, March 7, 2017

9 questions that still need to be answered about technology in clinical trials

ClinTech Month

Over the last six months we have spoken to dozens of industry experts about every aspect of technology in clinical trials. One thing that has stood out is that there are more questions than answers around the tech revolution at the moment. Here we have gathered some of the biggest questions and how industry leaders are attempting to answer them.

1) Which technology platforms are most shaping the way trials are run? We asked four leaders from different areas of clinical research about the platforms they are most excited about - including Matthew Zachary, Founder/CEO of Stupid Cancer, and Dr David Fajgenbaum, Executive Director of Castleman Disease Collaborative Network.

2) Are clinical trials ready for mHealth adoption in 2017? Technological implementation has been slower than many had hoped for. Will 2017 be the breakthrough year for integration?

3) How is mobile health aiding patient-centricity? Sarah Iqbal from Biotaware explores how mHealth and wearables are making the patient experience in research more positive, helping to improve recruitment and retention.

Friday, March 3, 2017

Clinical Trials of the Future: The Impacts of mHealth & Big Data

ClinTech Month

Few disagree that technology will have a profound impact on the clinical trials of the future. However, which aspects of technology will play the biggest role and how best to integrate them is still very much up for debate. We asked three industry leaders about the technologies they are most excited by and the benefits they hope they'll bring.

Anna Matranga, MD at AMC Alliances & Consulting, admits that currently 'we're not very good at adopting technology and supporting that technology', and she hopes that as we move forward, the human-to-human relationship is not forgotten.

KCR CEO Mike Jagielski offers a CRO perspective and is most excited by partnerships and mergers that are 'combining healthcare data more thoroughly with the service industry in the clinical research execution space'.

Oliver Timmis, AKU Society CEO, sees a 'greater reliance on real world data instead of doing a Phase III or IV trials' as solving one of the biggest problems in rare disease research; unreliable access to treatment.

Watch the full interviews in the video above or here.

This post is part of ClinTech Month - explore more here

The Next Wave of Clinical Innovation is one of four streams at T3: Trials, Tech and Transformation on May 11-12 in Orlando, Florida. Register before 3/17 and save up to $400 off standard rates, PLUS use the exclusive code T3BLOG17 to save an additional $200. Find out more here.

Wednesday, March 1, 2017

ClinTech Month: The implementation, benefits & challenges of technology in clinical trials

ClinTech Month

Technology is revolutionising clinical trials, impacting every aspect of research, but whilst wide-ranging challenges remain, the speed of implementation is slower than many had hoped. All this month we are focusing on these issues, bringing you exclusive video interviews, reports, case studies and views as part of ClinTech Month.

We’ll be exploring the ways in which technology is having a profound impact, the benefits it is bringing and the obstacles that need to be cleared.

Types of tech

The numbers around mHealth and wearables are pretty staggering - estimates suggest that by 2020 there will be 25 billion connected devices, 4 million patients using remote monitoring technologies and the Internet of Medical Things industry worth $117 million. These are the building blocks of the technology revolution in clinical trials.

With a vast amount of new data being created, the cloud and Big Data analytics are becoming increasingly important, whilst Electronic Medical Records (EMRs) are getting more complex, faster and smoother. Additionally, online social networks are being used for recruitment and to connect patients to one another.

Monday, February 27, 2017

End of study patient surveys and the future of patient-centricity

Exclusive interview: Adama Ibrahim, Senior Clinical Operations Lead, Biogen

'We are working in an evolving ecosystem where we are either intentionally or without much choice having to change the way we work with patients.'

For Adama Ibrahim, Senior Clinical Operations Lead at Biogen, taking a more patient-centric approach to clinical trials is no longer a choice, but instead central to the future of the drug development industry; 'For us to be successful we need to make sure the patient experience is optimal and we need to be able to address problems.' She goes on to describe:
‘We're dealing with people here, we're not talking about machines, so we need to make sure that we treat them like human beings…Try to be more collaborative, try to listen more, but in a way that will actually affect the way we work, not just pay lip service.'

Friday, February 24, 2017

Is Patient-Centricity at the Core of Clinical Trials?

Recruitment and retention of study subjects in clinical research is at an all-time low; the average retention rate in 2013 was 33% which is a 56% drop from 2003 levels. Patient centricity has to do with making the patient feel special, and therefore clinical trial participation attractive as well as more valuable to them. More importantly, an attitude of patient centricity helps with continuity of care, better diagnostic targeting and treatment outcomes, and thus retention.

We had the pleasure of sitting down with five leading clinical trial professionals to discuss how well clinical trials currently treat patients and to what extent patient-centricity is truly at the core of research. In this conversation, we look at the ways in which clinical research can be made more patient-friendly to enhance recruitment and retention, including wearable technology, social media, novel trial designs, data management, support groups and sensitivity to minorities.

Thursday, February 23, 2017

Clinical technology survey 2017 - complete for a chance to win a 2-day pass

Technology is changing the way clinical trials are run faster than ever before. There’s a huge amount of excitement and investment in mHealth, cloud-based tech, Big Data and Electronic Medical Records, yet there are also concerns over regulations, training and cost.

We are conducting one of the biggest surveys of its kind across our database of over 50,000 clinical trial professionals from within pharma, CROs, academia and patient groups. The final report will reveal unique insights into how companies view the challenges and benefits of different aspects of clinical technology, and to what extent they are implementing them.

Win a 2-day pass…

Completing the survey will take just 5 minutes and will give you exclusive early access to the final report. Plus everyone who completes the survey by 5th March 2017 will be entered into a prize draw for a free 2-day conference pass to T3: Trials, Tech and Transformation in Orlando, Florida on 11-12 May 2017 or to Partnerships in Clinical Trials Europe in Amsterdam on 28-29 November 2017. Full terms and conditions can be found here.

We’re excited to see the results of this unique study and we hope you are too.

Friday, February 17, 2017

'I'm a very big critic of the current approach towards research subject information sheets' - Dr Kieran Doran, Senior Healthcare Ethics lecturer

Patients as Partners Month

Dr Kieran Doran, Senior Healthcare Ethics lecturer at University College Cork, argues that one of the biggest failings of patient-centricity in clinical trials currently is patient consent. The information on consent forms is too often in very technical detail, whilst additionally there's often a 'telephone directory's worth of information'. For Dr Doran this is a major issue when 'the very basic concept of informed consent is that the patient can understand, retain and comprehend the information being given to them.'

Watch the full interview with Dr Doran above, where he also explores the benefits of a standardized approach to clinical trials across Europe, and the challenges of patient data confidentiality.

This post is part of Patients as Partners Month - explore more here

Patient-centricity is one of four streams at T3: Trials, Tech and Transformation on May 11-12 in Orlando, Florida. Register today and save up to $1,000 off standard rates and use the exclusive code T3BLOG17 to save an additional $200. Rates increase Friday, 1/27. Find out more here.

Tuesday, February 14, 2017

How is mobile health aiding patient-centricity?

Patients as Partners Month

As healthcare extends its ‘institutional’ role and becomes more personal and mobile, patient-centricity is becoming a significant strategic focus for healthcare stakeholders. The Institute of Medicine defines patient-centricity as a means of providing care that is transparent, respectful of and responsive to individual patient preferences, needs and values, ensuring that patient values guide all clinical decisions.  In other words, being truly patient-centric means that healthcare decisions are shared between patient and clinician.

More than any other aspect of drug development, patients are at the centre of clinical trials. Research has demonstrated that putting the patient at the heart of a clinical study by engaging them throughout the process, leads to greater compliance of patients' at-home medical care and results in more successful studies for all involved.

Driving greater patient engagement empowers the patient to take an active role in the decisions made about their own healthcare and the frequency of self-management behaviors increases. This not only drives improved patient participation in a clinical study, but also lowers the burden on the site. This is particularly critical in the clinical trial context because patient engagement is synonymous with compliance, which is vital to the progression of the trial.

Friday, February 10, 2017

Where can clinical trials most improve in their approach to patient-centricity?

Patients as Partners Month

As part of Patients as Partners Month, we spoke to six leading figures from pharma, CROs, academia and patient groups about the current state of patient-centricity in clinical trials. How can those running trials improve the treatment of patients and how big a difference does it truly make to research results?

The speakers include:
  • - Dr Richard Thompson: Scientific Officer at Findacure
  • - Rob DiCicco: VP, Clinical Innovation and Digital Platforms at GSK & Transcelerate
  • - Mike Jagielski: CEO at KCR
  • - Anna Matranga: Managing Director at AMC Alliances & Consulting
  • - Dr Kieran Doran: Senior Healthcare Ethics Lecturer at University College Cork
  • - Virgil Simons: President at Prostate Net Europa

Wednesday, February 8, 2017

7 case studies of patient-centricity in clinical trials

Patients as Partners Month

Patient-centricity is one of those terms that connects to so many different aspects of clinical trials and yet is so often discussed in broad, theoretical terms. Over the last six months, we have spoken to dozens of drug development professionals leading the way in putting the patient at the centre of clinical research. Here we have gathered seven examples of how they're doing it and where they are succeeding.

1) Taking a patient centric approach to pediatric clinical trials: 'We have more than 20 years of experience with adult patients, but far more limited experience with children and young patients.' Patient Advocacy Manager at Sant Joan de Déu Children’s Hospital in Barcelona, Begonya Nafria Escalera, explores strategies that put the patient at the core of research.

Monday, February 6, 2017

Are patient-centric initiatives working in drug development?

Interview with Stella Stergiopoulos, Senior Project Manager at Tufts CSDD 

As Senior Project Manager at Tufts Center for the Study of Drug Development, Stella Stergiopoulos manages multi-sponsored and grant funded research projects. Having led a 2016 study on patient-centric initiatives, Stergiopoulos is uniquely placed to assess how well the drug development industry is currently working with patients and how successful new strategies are proving. As part of our Patients as Partners Month, we spoke to Stergiopoulos about the state of patient-centricity in clinical trials today.

Friday, February 3, 2017

INDUSTRY OVERVIEW: Patient-centricity in clinical trials today

Patients as Partners Month

For February, we will be shifting our topical focus from Niche Outsourcing to Patients as Partners. Over the course of the month we’ll be bringing you a range of interviews, videos and opinions on patient-centricity in clinical trial outsourcing, procurement, operations, and innovation. 

The clinical trials industry has come a long way from where is once was, but there is plenty of room for growth and improvement. Many industry professionals know nearly 80% of clinical trials fall short of their recruitment targets and that an estimated 30% of participants will drop out of a trial before its completion.

As an industry, there is a general understanding that an advanced commitment to patient-centricity will shape the future of this space. However, two questions first need to be asked: what does patient-centricity really mean? And is it truly at the core of clinical trials?