Tuesday, October 25, 2016

Ask the Experts: 5 of the most exciting developments in clinical trials

With new technologies, partnerships and strategies developing in clinical trials all the time, the industry is changing at a rapid rate. Over the last six months we have spoken with dozens of clinical trial professionals and asked them what they think the most exciting developments are. Here we have gathered six of the most common answers we got.

1) Real-time data management

“The use of Apps and tablets for collection of data, to improve timing and quality of trials.” Isabella Salerio, Clinical Operation, Zambon

“Improved system interfaces leading to real-time reporting of clinical trial operational status at your fingertips – really supporting management and oversight of trials.” Julianne Hull, CEO, WenStar Enterprises

Friday, October 21, 2016

"Multi-million pound deals are being struck by sponsors and CROs with a little bit of hope and naivety"

Meeting the challenges of the sponsor/CRO partnership with John Faulkes, CEO of PPMLD

“Sponsors want now what they always have; they want the CRO to deliver what they say they will. But despite many years of experience and loads of money in the system, the intense conversation that goes on tells us that this doesn’t always happen.”

For John Faulkes, consultant and CEO of PPMLD, it is clear there are issues with most of the partnerships between sponsors and CROs at the moment. Despite the fact pharma companies have “tried all sorts of ways to make this work”, targets aren’t being met and budgets are being stretched.

One of the big debates over how to combat these issues is around long term strategic partnerships versus tactical outsourcing. However, for Faulkes, “that’s the wrong question; there are other things that are more fundamental that would make more of an impact”.

One such example is for sponsors and CROs to agree on more realistic propositions at the start of the partnership: “They need to learn from their experience…Even in this day and age, multi-million pound deals are being struck by sponsors and CROs with a little bit of hope and naivety sometimes.”

In this fascinating interview, Faulkes explains why there are issues all over the world and describes some of the ways he thinks partnerships could be improved - watch the full interview above.

John Faulkes is joining over 120 other industry leaders speaking at the Partnerships in Clinical Trials Europe conference in Vienna on 16-17 November 2016. Join 1000+ others with 10% off ticket prices by entering the code CQ3011BLOG at the checkout (T&Cs apply).

Thursday, October 20, 2016

If you had the power to change one thing about the clinical trial industry, what would it be?

We spoke to dozens of the leading experts working in clinical trials and asked them what the one thing they would change about the industry would be if they had the power. Here are some of their answers.

Simplification of regulations

An unsurprising one to start with, the complexity of regulations is a complaint bound to be heard at every conference. As Julianne Hull, CEO of WenStar Enterprises, explains, she would like the “Streamlining, simplification and clarity of new and ongoing regulations.” Wenke Schult, MD emovis home care visits GmbH, puts it even more simply: “Reduction of red tape”.

Tuesday, October 18, 2016

The past, present & future of wearable technology in clinical research

by Sarah Iqbal

The intersection of technology and healthcare covers a range of solutions in various sectors of the digital health industry. One particular solution is wearable technology. While healthcare organizations such as pharmaceuticals in clinical trials have not yet embraced wearables in large numbers, they are certainly intrigued. Wearables are emerging as a solution for creating more efficient clinical trial processes, from recruiting patients to collecting real-time patient data.

Mobile health (mHealth) tools that enable clinicians and researchers to monitor the type, quantity, and quality of everyday activities of trial participants have long been needed to improve daily care, design more clinically meaningful randomized trials, and establish cost-effective, evidence-based practices. Wearables (or activity trackers), also seen as a mobile health tool, have begun to fulfil this need.

Monday, October 17, 2016

Clinical research: Part art, part science, all communication

by Michael A. Martorelli, Fairmount Partners

I’ve followed contract research for twenty years as an investment analyst and banker. I’ve seen the industry fragment and consolidate, shrink and expand and I’ve used these observations to advise CROs and other service providers of the opportunities and pitfalls.

The most important lesson I’ve learned is that having a clear aim from the outset is the key to success in any drug development project.

The goal of clinical research is to provide regulators with the information they need to make informed decisions about the marketability of new therapeutic products as quickly and efficiently as possible.

Friday, October 14, 2016

What is a project leader’s real source of authority? Interview with consultant John Faulkes

As CEO of PPMLD, John Faulkes spends his days helping life science projects work more efficiently through collaboration. We sat down with him to ask what good project management looks like in a sponsor/CRO partnership.

For John, the key to building the perfect team is all about developing the members of that team; ‘Great teams have lots of features, but two in particular are: every player works towards a common goal, and there is a level of trust in the team.’

He explains that ‘Team members need to be developed so they can give quality input into the system and the project manager can trust it and not bore down into the details. The project manager can then stick to the leadership issues.’

If this can be achieved, ‘the long term aim should be to generate in the extended team a “one team atmosphere”. It may be possible, it may not be possible and if it is, it does take a long time.’

John Faulkes is joining over 120 other industry leaders speaking at the Partnerships in Clinical Trials Europe conference in Vienna on 16-17 November 2016. Join 1000+ others with 10% off ticket prices by entering the code CQ3011BLOG at the checkout (T&Cs apply).

3 Key Takeaways from 2016 Partnerships in Clinical Trials US

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

Steve Wozniak is the keynote at the Biotech Week Boston
Photo credit: @TogoRun
The 2016 Partnerships in Clinical Trials (PCT) conference, held as part of Biotech Week Boston (BWB) on October 4-7, proved a valuable opportunity to both network with industry peers and learn more about the state of clinical research. I appreciated hearing expert proposals and updates from leaders in the research industry on topics such as data, collaboration and technology. I came away from PCT brimming with ideas and a better understanding of what’s needed for future improvement in the industry. Here are a few of my takeaways from a week filled with actionable insights:

1. The ‘deluge of data’ needs to be refined.

During his presentation on technology’s influence in clinical research, Kailash Swarna of IBM Watson Health Group discussed the potential for Big Data to improve drug development. Swarna began by celebrating the industry’s ability to collect patient data that could lead to more informed clinical trials. He affirmed the potential of Big Data to be used for predictive modeling, remote monitoring, personalized medicine and more. However, Swarna noted that many clinical trials collect far too much study data and aren’t able to use it for these purposes. He proposed the solution is to identify meaningful patterns in the “deluge of data.”

Read more

Thursday, October 13, 2016

3 keys to patient centricity in clinical trials

There was a lot of talk on patient centricity and sustainable patient recruitment for clinical trials at the Partnerships in Clinical Trials US conference this October in Boston. We've gathered some of the key takeaways from industry leaders.

While speaking on utilizing technology solutions to talk to patients, Melanie Goodman, Patient Recruitment Planning at ICON, emphasized two big ideas. Firstly, it’s important to have an understanding of where our audience is, so we can provide them with the information in a timely manner and via the platform they are using. And secondly, we have to understand who the patients are as consumers, and Patient Profiling helps with that.

1) What is a Patient Profile?

In order to answer this question, we first need to address some of the following questions:

    - What are the people looking for?
    - How are they looking for it?
    - Who are we looking for?
    - How can the new technology help patients?
    - How do we understand our patients?

Social listening comes in handy when tapping into the conversations taking place on various social media platforms. Social listening helps identifying the influencers – those who influence patients’ decisions; it helps to monitor spikes of stories and engagement; it helps to learn the language patients use to describe their symptoms, but also it provides a way to watch the conversations as they unfold.

Wednesday, October 12, 2016

Words of wisdom from Woz the Wizard

Steve Wozniak, the co-founder of Apple and the man who developed the first personal computer, came to Biotech Week Boston and Partnerships in Clinical Trials to talk about innovation and patient centricity.

Woz the Wizard was just as joyful, playful, curious and enthusiastic as ever. His advice for this generation of entrepreneurs: 
“You know in your heart what you like doing. Do that.”
"Engineers like solving complicated problems, so get them on board in a new company as quickly as possible," he told the audience. "Hire people who have built stuff – started programs and finished them. Engineers don’t necessarily have to have lots of degrees – what they do need is a history of invention."

Tuesday, October 11, 2016

Whitepaper: Is patient centricity truly at the core of clinical trials?

The complexity of clinical research trials, their exorbitant cost, and poor patient recruitment has reached a critical junction where novel methods of data design and recruitment are essential.  Fortunately, the offspring of technology and the internet has provided options that promote patient recruitment and retention, cut costs and avoid much of the paperwork and angst involved in clinical trials.

The ubiquitous smartphone can be used in a variety of ways. It is a way for researchers to remind patients to take their medications, be available for appointments, and give encouragement and transmit news. Innovative giants like Google and Apple have developed novel wearable devices and app development software so that the patient’s status can be monitored continuously and remotely.  Patients are not inconvenienced by having to travel to the research site which allows researchers access to the elderly, infirm, and rural patients. In addition, study nurses can go to the patients for follow up.

What will the US presidential race mean for healthcare?

Biotech Week Boston. Panel: What our next President mean for Biotech and Pharma

by Julie Walters, Founder Raremark

We’ve heard a lot about the presidential candidates’ tone, style and experience in the presidential debate, but what about their actual policies - particularly in healthcare? Delegates at Biotech Week Boston heard from industry leaders and commentators on what to expect, depending on who wins.

Kathleen Weldon Tregoning, Senior VP, Corporate Affairs at Biogen thought a Democratic win would mean no real surprises as Hillary Clinton has a lot of well-documented policies in health and a long history in the space. The Democratic nominee knows full well that any change in healthcare will be hard. Dylan Scott, Washington correspondent with Statnews.com thought one of Hillary’s first priorities, if she won, would be to decide on where to spend her energies. If the Affordable Care Act (ACA) faces further challenges, he predicted that, in defense of her predecessor’s legacy, ACA would become her first priority.

Less predictable were the policies of the Republican candidate. 

Friday, October 7, 2016

Applying Wozniak’s Take on Innovation to Clinical Research


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

Admittedly, my inner technology nerd squealed with excitement at the chance to hear Steve Wozniak, Co-Founder/Chief Scientist at Apple Computer, speak at Biotech Week Boston (BWB) today. Wozniak's presence at BWB and Partnerships in Clinical Trials US proved very appropriate, reasserting some of the overarching themes that have maintained a consistent presence over the past three days. Wozniak’s talk served as a reminder of the power of innovation to produce real results and ultimately influence the way individuals function on a daily basis. In the clinical research industry, similar innovation and forward thinking can lead to life-changing therapies, as well as improvements to the drug development process overall.

Aligning the industry 

During his interview, Wozniak touched on the need for companies to remain open to change. He noted, “When something simpler comes along, you often don’t see it.” Wozniak applied this to the unfortunate tendency for corporate culture to adopt an attitude of stagnation, holding to age old values rather than adjusting to meet changes in society. In clinical research, this is all too familiar. While the research industry is full of brilliant minds and innovative ideas, the clinical trial process and its associated bodies are notoriously slow to adopt change. This slow adoption may be attributed to stakeholder silos, largely between sponsors, sites and patients.

Deciphering a Deluge of Data: Patient Support


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

The shear amount of data generated by each person is truly mind-blowing. Be it online shopping, locating the nearest coffee shop, or tracking what you ate for lunch, your devices have become inseparable parts of your daily life. The actions you perform when using your phone or laptop become tiny droplets in the enormous ocean of consumer data produced on a daily basis. 

Albeit a bit unsettling, it’s hard to ignore the immense potential of this data pool, if only it could be deciphered. During day two of Partnerships in Clinical Trials US, data-deciphering became a theme throughout the course of many presentations. Several presenters discussed the potential to target patterns in the ‘deluge of data’ for use in clinical research, including finding novel therapies for infectious diseases, aiding in the search for an Alzheimer’s cure, and creating predictive models of clinical research. All of these ideas are incredible and could lead to greater efficiencies in clinical trial conduct. However, one idea stood out to me as a concept so universally applicable: using data to enhance the patient experience.

Thursday, October 6, 2016

Preparedness and Collaboration as a Response to Global Health Epidemics


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

Epidemics are the stuff of nightmares. Particularly in the clinical research field, epidemics pose many challenges, often requiring rapid action, immediate trial start-up, and low-standard good clinical practice (GCP), among other struggles. Ultimately, it’s incredibly difficult to conduct a clinical trial during the course of an epidemic. Ebola and Zika are two recent (and current) global health concerns that serve to illustrate these challenges, and continue to test researchers.

However bleak this may seem, such challenges can be overcome. On day two of Partnerships in Clinical Trials US, two inspiring presenters shared their journeys working to combat infectious diseases, such as Ebola and Zika, in Third World countries. Both presenters asserted the common idea that the research industry needs to work together to become more prepared for epidemic response before an outbreak occurs.

Mind Blown: PCT US 2016 on Big Data

Day 2 of Partnerships in Clinical Trials US (PCT US) was, as the title to this piece suggests, pretty incredible. From hearing about IBM Watson’s vision for what is essentially population health times a gazillion, to more sobering facts about failures in Alzheimer’s research and incremental progress in developing countries around diseases that are 100% eradicable, by noon my head was spinning. And if that wasn’t enough, I listened to Dr. Trudie Lang share her fascinating experiences setting up rapid-deployment (think near-time) trials to stem the harm of both Ebola and Zika. I found her to be awe-inspiring.

So given these varied lectures, from topic to tone, was there a single thread takeaway? Indeed there was, and that would be DATA.

Patients as a partner in Aspirin clinical research

Technology is putting more power into the hands of patients and clinical trial recruitment is no different.

One of the first sessions of Partnerships in Clinical Trials US heard how virtual trials, personalized patient data and the use of electronic health records (EHR) are part of pioneering efforts in patient recruitment. Lisa Berdan, a Director of Duke Clinical Research Institute shared early progress in the ADAPTABLE Aspirin Study, which compares the effectiveness of two daily doses of aspirin to prevent heart attacks and strokes in individuals living with heart disease. The study is the first project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network, to improve the US’s capacity in clinical research.

Delegates heard how patients had been involved at every step of the trial, from design to including patient representatives on the executive and data & safety committees.

Wednesday, October 5, 2016

It All Comes Down to Marketing

As a marketing professional I have long theorized that in life, it all comes down to… marketing. Think about it – from getting accepted into college, getting a date, finding a job – it (mostly) has to do with how one positions oneself (think “personal brand”) along with place (being in the right one) and promotion (the offer). Earlier today I sat in on the Patient Recruitment & Identification track at Partnerships in Clinical Trials US and couldn’t help but think… recruitment sounds a lot like marketing.

Listening to Melanie Goodwin from ICON, her message was clear, that when it comes to leveraging technology to engage patients for research... know thy audience. Technology is but one of the tools available to investigators and researchers, and it can pay dividends if applied to the right target. When talking about identifying attributes of the “right target," Melanie referred to this as a Patient Profile – she also suggested a term I’d never heard before, social listening, as a strategy to understand where and how potential patients gather information.

A Bittersweet Symphony

The inspiring founder of Stupid Cancer, Matthew Zachary, kicked off Partnerships in Clinical Trials US with a moving keynote address that included a live piano concert of his original compositions. As he told his cancer story – diagnosed with a life threatening brain tumor at the age of 21 (only after Robitussin didn’t help symptoms that, if I recall correctly, didn’t include a cough) – I felt the tears swell in my eyes.

When it comes to cancer, I’m biased. Every day for over two years I have watched my eldest son, now 9, try to beat back an aggressive cancer that previously took the life of his brother. But hearing Matthew and his co-presenter David Fuehrer (Go Tigers!) share their experiences as young adults being treated for cancer, it was certainly enlightening. My reason for being these days is to cure my son, to protect my son, to tell him it is all going to be okay. Now, if my son was 21, that would not be so easy – it would in fact be impossible. I would not be the steward of his treatment, I would be an observer. I would have opinions and I would offer those, but ultimately, treatment choices would be his own.

Monday, October 3, 2016

The Value of Rare Diseases

It’s a busy month in Boston. Just a few days before Partnerships in Clinical Trials US (PCT), leading researchers and investors kicked off the discussion at HubWeek on the value of rare disease.

A panel discussion headlined “Is Every Disease a Rare Disease?” heard of the evolution of disease and what the future might hold in terms of new treatments.

When the first International Classification of Diseases (ICD) was published back in 1900, just 174 diseases were identified. The latest edition, ICD10, has over 8,000 diseases.

Anna Greka MD, PhD of the Broad Institute said molecular markers are now allowing us to target cancers in a new way, but we are really just scratching the surface on the specificity of a particular disease.

Genome-wide association studies (GWAS) that look at the genetic variants in a specific population can help identify a genetic target, particularly in rare disease.

Friday, September 30, 2016

Can Big Data Cure Cancer?

"The release of public data is the next big world in the clinical trials space and neutral third parties who are not part of the trial are going to innovate using our trials data." Atul Butte MD, PhD, Director of the Institute of Computational Health Sciences, University of California, San Francisco (UCSF)

The release of public data is the future of clinical trials. With about 50% of clinical trials failing, outside of summaries on clinicaltrials.gov, the raw data is never distributed for review. And what would this mean for the industry? It means that more questioning and review would happen, truly getting to the bottom of why a trial failed or succeeded. These third party researchers will be able to draw conclusions, like for instance "that the drug is working in a subset of patients", then that discovery will be present in trials moving forward - thus innovating the field.

Find out all the good that Atul feels proper data management and review will have for the industry in this exclusive interview.

Thursday, September 29, 2016

Rare Disease Research: It Pays to Engage

Michael Christel, Pharmaceutical Executive

Behind the momentum of precision medicine programs such as Cancer Moonshot, coupled with the overall shift taking place toward ultra-targeted treatments—gene therapy, immunotherapy, biologics—the rare disease space seems to be joining the rarefied air of more common disease segments in biopharma business pursuits.

After all, by 2020, the rare and orphan drug market is forecast to grab 20.2% of worldwide prescription drug sales (excluding generics) and total $178 billion in annual revenue. In the US, the FDA granted nearly double the number of orphan drug designations in 2015 compared to 2010. The demographics are well documented: rare diseases affect fewer than 200,000 patients, but, in aggregate, afflict as many as 350 million people worldwide—more than the total for cancer and AIDS combined. Children are especially impacted; about 35% of deaths in the first year of life are reportedly caused by these conditions.

But despite greater financial and regulatory incentives to develop drugs for rare diseases, plenty of caution remains. The low prevalence of these conditions still results in various challenges in development, pricing, and reimbursement. And with treatments usually requiring large per-patient payments, this area won’t be immune to the pricing scrutiny that continues to swarm the industry.

Juliet Moritz, executive director of strategic development in rare diseases for Premier Research, a CRO, has watched all these trends unfold with a close eye. Involved in clinical research for 28 years, with experience in single-site studies as well as large, multinational trials, Moritz is particularly passionate about informed consent and the role of patient advocacy involvement in clinical research and its impact on the regulatory process.

To get the pulse of rare disease research at the moment, Pharm Exec recently chatted with Moritz, where she discussed the challenges and opportunities unique to this specialty market—particularly related to growing focus areas such as patient engagement.

Wednesday, September 28, 2016

Why use home care visits in clinical trials?

by Dr Bettina Bergtholdt, Managing partner at Emovis

Study participation can cause significant burden for patients: the frequency of requested clinic visits is usually high, the time spent at the study site can exceed many hours until all requested data are collected and not to forget the sheer travel time. Even in studies with a patient population suffering from mild diseases, the time consuming aspect of study participation keeps many eligible patients off from taking part in studies.

Recruitment rates and drop-out rates are even more affected by the burden of study participation in the following groups of patients:
  • - Severely ill patients, particularly those with a life-threatening or disabling diagnosis, as clinic visits might become more difficult
  • - Rare diseases, if distances between study site and home of patients are quite far
To avoid low recruitment rates or high drop-out rates in such studies, the concept of home care visits in clinical studies is becoming more and more popular over the last years.

Tuesday, September 27, 2016

The Need for Patient-Centric Payments in Clinical Trials

by Shree Kalluri
Patient recruitment for clinical trials

The traditional process of paying stipends and reimbursements to participants is still a prevalent issue in clinical trials. This payment process has typically followed an outdated, manual model that rarely takes into account a patient’s lifestyle and personal preferences. Today, some of the most common or traditional payment methods used in clinical studies are often the least patient-centric.

In many clinical trials, participants are only provided with a single payment option, often in the form of a check. Patients can be left waiting anywhere from four to eight weeks before receiving a single payment. This is especially inconvenient, as many patients have to personally pay upfront, out-of-pocket expenses to get to the site. Additional expenses could also include lodging, childcare, meals and the cost of time missed from work. With this prolonged and slow payment model, participants could be on their next study visit before ever receiving payment from their previous visit.

Monday, September 26, 2016

The Power of Predictive Analytics For Life Sciences

Today’s guest post comes from David Lee, chief data officer at Medidata Solutions. Don’t miss his presentation at PCT US on October 6 on predictive modeling.

Predictive modeling for life sciences

The confluence of new data sources and new predictive modeling methods is revolutionizing clinical trials and the development of experimental therapies. Predictive modeling can play an essential role in three fundamental aspects of clinical trials: improving data quality, increasing operational efficiency, and including data from new sources.

Data quality

We’ve all heard the saying, “Garbage in, garbage out.” Data quality – accuracy and completeness – is vital to the scientific return on the investment in clinical trials. Inaccurate data arise frequently from a variety of sources, including entry errors, insufficient training, subjective differences and even site misconduct. Predictive models can be utilized to identify anomalies in clinical data in near real time; these can then be systematically corrected, well before database lock. Further, automated error detection can alert sponsors to data problems, whether or not these are expected. Sponsors, CROs, and regulators alike will benefit from this new paradigm in data quality, which is improving the quality of clinical data and the resulting scientific findings.

Friday, September 23, 2016

Stupid Cancer Founder Matthew Zachary's Story

After surviving brain cancer as a 21-year-old, Matthew Zachary founded Stupid Cancer in 2007 to address the 72,000 new diagnoses of young adult cancer each year. It has since grown in to the largest US charity providing advocacy, research and support for the often neglected group of 15 - 39-year-olds.

We spoke to the self-described ‘global healthcare disruptor and Chief Angry Officer’ about his story and how patients are treated.

Matthew is speaking at Partnerships in Clinical Trials Europe in Vienna on 16 November 2016. Join over 1000 clinical trials industry leaders at the two day event - find out more here