Galien Forum USA

Modernizing Medicine through Decentralized Clinical Trials

MaryAnne Rizk is a Chief Strategy Officer at Medable.

Save the Date!

Decentralized clinical trials are rising in demand. What have we learned from the past 20 months – and where do we go from here? Medable discussed these critical issues during a powerhouse panel at last month’s Galien Forum USA 2021 that included leaders from AstraZeneca, Bayer, CVS, Medable, Takeda, and Verily/Former FDA Deputy Commissioner. While opinions varied on some topics, there was consensus around technology: if we use it well, it can help us bring more effective treatments to patients around the world faster than ever before.

I hosted the hour-long panel featuring six experts working at the forefront working to decentralize and diversify the clinical trial experience:

  • Dr. Robert Califf, Head of Clinical Policy & Strategy, Verily and Former FDA Deputy Commissioner
  • Tony Clapsis, Vice President, CVS Clinical Trial Services
  • Dr. Cristina Durán, Chief Digital Health Officer, R&D, AstraZeneca
  • Dr. Sebastian Guth, President of Bayer Pharmaceuticals, Americas Region
  • Dr. Michelle Longmire, Co-Founder & CEO, Medable
  • Dr. Andrew Plump, President, Research & Development, Takeda Pharmaceuticals

It covered several themes, beginning with the pandemic’s influence on trials and decentralized clinical trial adoption. Before COVID-19, Bayer’s Dr. Sebastian Guth said clinical research felt like a “race of the turtles.” The panelists agreed that randomized clinical trials are one of the great inventions of the 20th century, enabling us to develop and discover drugs safely while dramatically improving the quality and length of human life. However, as Takeda’s Dr. Andrew Plump noted, the clinical trial process is also often “brutal” – sluggish, inefficient, and expensive.

So, while the pandemic has undeniably solidified the need and urgency for decentralization, the movement was already underway well before the outbreak. Verily’s Dr. Robert Califf noted the importance of the 21st Century Cures Act of 2016, which helped spur the focus on real-world data (RWD), direct communication with patients, and broader access to clinical research. Tony Clapsis from CVS Clinical Trial Services emphasized the company’s 20-year effort to build a community around pharmacies, including the largest home infusion business in the US.

These and other pathways, intended to diversify clinical trials, were instrumental to the industry’s ability to respond quickly to COVID-19. AstraZeneca’s Dr. Cristina Duran shared perspective from their years-long effort to collaborate with patients on ways to improve clinical trials, well before launching into COVID vaccine development. AstraZeneca found that 70% of its traditionally onsite trials could be decentralized. And they saw firsthand the positive results of decentralization, including reduced patient burden and a better standard of care translating into significant improvements in patient participation and patient experience. These benefits contributed to AstraZeneca successfully delivering one of the first COVID-19 vaccines.

While the last 18 months forced the industry to rethink and reshape the way trials work, panelists reinforced that the pandemic response is only the beginning. Several noted that we are at the forefront of a new ecosystem, where every single person suffering from illness will someday have access to the very best research, treatment, and clinicians. In this future, trial data is more representative and reflective of populations living with these conditions, and those patients have access in an earlier phase to benefit from therapies earlier. At CVS, sponsors who had long been interested in standing up community-focused research sites were inspired  to execute that vision. As a result, CVS now has 15 research sites and will have 40 by year’s end – which combined have engaged more than one million patients to date.

Medable’s Dr. Michelle Longmire, along with Verily’s Califf and Bayer’s Guth, emphasized the need for this ecosystem to combine personalized medicine – marked by convenience, access, and trust – with better integration between clinical trials and clinicians. Dr. Longmire asked the audience to consider how we can better empower physicians to serve as gateways between patients and potentially life-saving trials, lamenting the fact that medical school does not teach physicians how to make those connections. Dr. Califf agreed saying, “as long as we keep the clinical trial world separate from the clinical world, we will never achieve the goal of a learning health system.”

These disconnections can also be improved through better communication with the public, emphasized CVS’ Tony Clapsis. The industry must focus on increasing the public’s awareness and ease of access to trials. Of CVS’ surveyed customers, 90% wanted to hear about available trials. When CVS reached out to the first million respondents, nearly none of them had been contacted before about a trial. If we hope to achieve true diversity, Clapsis said we must first look upstream and work with partners to dramatically increase awareness and ease of entry.

Of course, several other impediments remain on the road to decentralization. One of those is a lack of standards around new technology implementation, and the need for industry collaboration in developing those standards. Another impediment is trust in technology – yet another argument for better communication with the public and other stakeholders. Thoughtful communication will also be essential to avoiding another pitfall: overlooking potential trial participants who are not “connected,” educated, or activated – the very populations who might benefit the most from these trials.

Medable’s Dr. Longmire argued that we are living in an era of exponential medicine, where the potential to create new, effective therapies has never been greater. No one company on its own can empower this shared vision of a decentralized, diverse research landscape. We must continue working together across industries and communities, evolving science and technology, and building communication and trust – all in an effort to optimize for a future we know we can achieve.