With the end of the 14th annual Summit for Clinical Operations Executives (SCOPE) in sight, we asked our peers to lend some key takeaways from this year’s conference to get a sense of where our industry’s headed in 2023.
As first reported by 1nHealth’s Steve Wimmer, the word decentralized and the acronym “DCT” have a total of 242 mentions across the 2023 Scope agenda. This is almost two times as many mentions as other hot topics such as diversity, equity, and inclusion.
This agenda is reflective of what many feel is a shifting balance in clinical conduct, with top pharma like GSK and Sanofi signing multi-year deals with digital and decentralized companies, Tufts CSDD producing the first evidence of greater ROI, and regulators showcasing support for digital and decentralized trials.
Caroline Jackson, Executive Vice President of Patient Services of MDGroup, in an interview given to Outsourcing Pharma prior to her SCOPE presentation, noted that decentralized and hybrid trials could be the “holy grail” in terms of maximizing both data quality and patient experience.
Based on the MDGroup’s experiences, bringing trials closer to home results in happier participants due to reduced burden, happier sites due to patients remaining engaged, and happier clients as studies complete quicker than traditional trials while retaining high-quality data.
Taken in a larger context with recent ROI, coming regulations, and patient support, digitally-enabled drug development and DCT looks to become the “new norm.”
Presenting on the first day of SCOPE 2023, Jamie Brewer, MD, Office of Oncologic Diseases, FDA, discussed the implications of the FDA’s draft guidance around clinical trial diversity.
In her presentation, Dr. Brewer covered the implications and findings of three separate FDA guidance documents (Collection of Race and Ethnicity Data in Clinical Trials, Enhancing the Diversity of Clinical Trial Populations, and Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations), outlining the plan of action that companies can use to enroll diverse populations while also showcasing examples of previous trials that were successful in enrolling diverse participants.
With the DEPICT Act coming, industry-wide efforts to drive more diverse populations are expected to be at the forefront of clinical research in 2023 and beyond.
With guidance from Tufts CSDD showing the power of unified digital systems driving ROI, the question for many sponsors has shifted from “Why choose digital or DCT” to “How can we effectively and efficiently scale?”
As mentioned above, the shift has already begun with companies like GSK and Sanofi signing multi-year deals with decentralized clinical trial companies in order to bring unity to their clinical trial offerings.
With the roles of sites changing as clinical trial conduct changes, several presentations focused on the importance of site engagement.
Among the presentations, key takeaways were that companies who make changes in clinical practice, conduct, and/or technology must properly onboard these changes to sites. This includes proactive notices of changes, bolstered by proper training and support.
During her presentation, Medable’s Executive General Manager, Digital and Decentralized Solutions, Ali Holland showcased key evidence showcasing that engaging sites with support teams drove a 27% reduction in site-facing issues during clinical conduct.
As she stated towards the end of her presentation, “Proactive engagement reduces site burden and improved site efficiency, leading to more successful patient onboarding.”
Several presentations tackled the continued focus on developing clinical research around patient needs.
In a presentation titled “Increasing Patient Engagement and Retention through Patient-first Digital Trial Solutions,” Medable’s General Manager of Decentralized Clinical Care noted that the patient experience must be paired with evidence generation as we move forward.
Echoing this sentiment were presentations from a host of companies. Chief among them was a striking presentation from Genentech’s Virginia Nido, Global Head, Product Development Industry Collaborations, titled “Would I Want My Mother to Be Part of a Clinical Trial?”
The key takeaway here, and from SCOPE 2023, is that pharma executives must be diligent in learning and deploying new technologies and resources when available. Otherwise, the industry may fail in creating trials in which people want to participate.
“My call to action to you is to learn this landscape of clinical trial solutions. You have the power and you have the ethical imperative to make trials the best they can be for your mom and for every patient.” — Virginia Nido