The 1st-ever virtual clinical trials conference is in the books! At the beginning of December in Philadelphia, representatives from the FDA and leading research organizations gathered to discuss technology and strategies that are poised to usher in a new area of clinical research with greater efficiency, patient diversity, and a new wave of life-enhancing treatments.
We are proud to have sponsored this milestone event and are lucky to have had the opportunity to hear firsthand from the innovators that are bringing decentralized trials into the clinical research mainstream. Here are 3 key takeaways from this conference:
The FDA supports decentralized trials, and several reps were in attendance
For many organizations, perhaps the biggest hurdle to implementing innovative protocols and technology is compliance concerns. However, when it comes to decentralized trials, the FDA has made their opinion clear: they encourage organizations to utilize new research models to streamline workflows, improve patient diversity, and collect more real-world evidence (RWE).
During both days of the conference, officers from the FDA spoke out on crucial issues surrounding decentralized trials. Dr. Isaac R. Rodriguez-Chavez, an FDA officer for clinical research methodology, regulatory compliance, and medical policy at CDER, gave talks on implementing new tech into VCT workflows, trial innovation, and navigating the current regulatory landscape. Additionally, Dr. Brittney Goldberg shared insight on using decentralized trials to enhance safety monitoring.
There was a strong presence from leading pharma companies
Many of the largest research organizations are getting involved in the decentralized clinical trial movement. At the beginning of each day of the conference, speakers from Johnson and Jonson and Pfizer welcomed attendees and kicked off the discussions. These two organizations also presented on using decentralized trials to enhance patient engagement, participation, and retention.
On top of this, Otsuka Pharmaceutical presented a central nervous system (CNS) case study that utilized a VCT model. Speakers from Sanofi and AbbVie also discussed decentralized trial logistics, workflows, and even legal issues to take into account.
Diagnostics and medical device research were in the spotlight
Although there was plenty of representation from pharma, this conference focused on other industries as well. There was a panel discussion on how decentralized clinical trials can improve safety monitoring and patient follow up for diagnostics and medical device research. Speakers from the FDA, Pfizer, Merck, and Sanofi all shared their insights.
As this decade comes to a close, we’re excited to see the horizon of a new era of clinical research rapidly approaching. We’re proud to call the first virtual clinical trials conference a success and to support the innovators leading the way. We look forward to more decentralized pilot programs in 2020 and to taking further steps to overcoming long-standing research hurdles and expanding the possibilities of modern medicine.