On February 7-10, 2022, the 13th annual SCOPE Summit for Clinical Ops took place in Orlando, FL. The conference, which is one of the industry’s premier events, serves as a barometer for identifying the biggest topics, concerns, and solutions within the clinical research world today.
For over three days, speakers and attendees were treated to discussions around:
While over 11 subjects were covered, topics that dominated the discourse outside of sessions included: news around Tufts decentralized research, new FDA guidance on digital health devices, the entrance of retail pharmacy into clinical research, and connected data strategies.
Fresh off its recent press announcements with CVS Health and Tufts, Medable helped lead some of these conversations - proving the effectiveness of decentralized trials and their patient-centric approaches. Medable, which was recently named the leader in decentralized clinical trials by Everest also launched its Medable Partner Network at SCOPE 2022, showcasing the value of organizations who join forces to bring patient-centric approaches to patients faster than ever before.
New Tuft’s Research Shows Benefits of DCT
Many sponsors were enthusiastic about the first-ever Tufts CSDD analysis on DCT, which models how DCTs can reduce clinical trial timelines and achieve net financial benefits ranging from five to 13 times for Phase II and Phase III trials.
Other key benefits indicated by Tufts are lower screen failure rates and protocol amendments
Retail Pharmacy is Expanding Patient Access to Clinical Research
CVS Health's recent announcement into the world of clinical research was widely discussed. Many in attendance believe that retail pharmacies will help unlock access to clinical research studies for millions of Americans.
Expansion into retail pharmacies can help connect more Americans to clinical research while helping improve trial diversity. Currently, only 4% of Americans are involved in clinical research.
New FDA Guidance on Digital Health Technologies (DHT)
Several sponsors referenced the new FDA guidance around DHT, discussing how best to ensure organizations reduce the burden on patients and sites while showcasing the value of their data.
Sponsors are now obligated to demonstrate that their digital health technologies are “fit for purpose.”
This means that the technology has been verified to collect the study's relevant data points and that patient populations must be able to use the technology with ease.
Connected Health and Data Aggregation
Sponsors and CROs like Novartis, Sanofi, and PPD stressed the importance of developing a connected, patient-centric strategy at scale that offers better insights and enables better decision making.
Unified data is crucial for developing biomarkers and digital endpoints. PPD showed how to select the right vendors to simplify data collection, aggregation, and patient-centricity.