Digital Technology: The Key to Accelerating Clinical Research

March 16th, 2016
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Historically in healthcare, technology developments have outpaced clinical researchers’ ability to leverage these advancements. However, that trend seems to be changing – particularly as it pertains to digital technology and devices. The penetration of mobile devices worldwide is over 50% with close to 4 billion users – and they are quickly becoming our primary tool to monitor health behaviors and collect relevant data. Mobile adoption could help to accelerate clinical research like never before.

Global-Snapshot-Jan-2016

Digital technology at work

Last year, shortly after Apple launched its open source platform, ResearchKit, researchers at Stanford Medical School developed MyHeartCounts, one of the first apps to be used on the platform. The app allowed each consumer/patient to participate in a population-based clinical trial measuring fitness, activity, and diet. Through the use of sensors on the iPhone (or compatible wearable activity trackers), MyHeartCounts provides feedback to the participant on their cardiac risk.

As we know, often trials can’t get off the ground due to lagging recruitment and enrollment… however unbelievably, over 11,000 people signed up for the cardiac study within 24 hours of opening enrollment – a record for any clinical trial. This is not only good for the Stanford researchers seeking insights into cardiovascular health, but also for the industry as an encouraging sign about the use of digital platforms as a means to effect widespread clinical trial participation.

In addition, pharmaceutical companies are also looking for ways to incorporate devices to engage their customers and collect data for stakeholders – clinicians, payors and patients. Bayer, Merck, Novartis and Pflizer are leaders in this area with several apps developed in pharma, coordinating the efforts of devices and drugs to track patient outcomes and better manage chronic disease. TransCelerate is a partnership of several pharmaceutical companies with initiatives to help share data and enable sites and sponsors through technology to improve the clinical trial process.

Clinical device trials incorporate activity trackers, biosensors, and smartphones with apps into protocols for depression, Parkinson’s, concussions, metabolic disorders, mindfulness training, and many other indications. In fact, clinicaltrials.gov posts over 1,000 studies with the term “app” in the trial description. It is expected that this increased collaboration between pharmaceutical companies will create more efficient clinical trials and in turn lower the cost of developing new drugs.

Beyond the pill

Some pharmaceutical companies have even begun to utilize social media for more targeted patient outreach – including partnering with online patient communities such as MyHealthTeams to recruit patients and to find more efficient ways to conduct research.

Through the social community, MyMSTeam (multiple sclerosis), Biogen Idec was able to target a subset of people living with relapsing MS. Biogen was able to screen and recruit many more potential participants through the social site than through the standard recruitment method. Since we interviewed co-founder Eric Peacock in 2013, MyHealthTeams has seen tremendous growth in membership and in the addition of several new health teams in autoimmune disease, neurology, mental health and others.

Patient engagement through social media has helped researchers design protocols, provide feedback on drugs/devices and their potential unknown side effects, and inform researchers on pertinent topics not previously considered without patient input. What used to be investigator- or sponsor- driven is becoming more patient-driven through technology.

The benefits of digital technology in clinical research:

  • Capture real-time data in a unified platform
  • Share information for better decision making – including early-stage planning and protocol development, central monitoring, or termination of a study if not feasible
  • Utilize Electronic Health Records (EHRs) to help target patient populations for specific studies
  • Eliminate the need for study participants to visit a provider to find out about clinical trials
  • Capture data on tablets/phones/computers, including: patient diaries, side effects, symptoms, and more
  • Enroll subjects faster – especially in hard to reach, diverse populations, and with rare conditions
  • Potentially realize overall cost-savings
  • Leverage for large scale studies

 

Technology can help to inform and improve patient engagement and streamline clinical research. At Popper and Company, we stay on the leading edge of medical technology developments and market trends so that we can bring our best, informed thinking to our clients. We can help you create growth strategies, stimulate product ideas, and find your best route to market – sometimes by thinking a bit unconventionally.

 

To learn more, give us a call at (410) 246-6524.

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About the Author:

I have 20 years experience in clinical research, including leading diagnostic and pharmaceutical clinical studies in disease areas ranging from cancer to infectious disease to cardiology, diabetes, and autoimmune disorders. Send me an email.