This year’s #SCOPESummit
yielded many key insights for our Clinical Research team to carry forward into their work to reimagine how clinical trials are executed. We’re sharing our top five below:?
#1. It’s becoming increasingly common, and necessary, to use real world data and evidence (RWD/RWE) in clinical trials to create a more complete evidence picture.
- We continue to see more conversations on the importance of capturing clinical data that is generalizable, longitudinal, and deep.There were over 30 presentations on the topic, including one by Flatiron’s own Dr. Hugh Levaux and Lauren Sutton on “Mechanisms for Transferring Structured and Unstructured Data from the EHR at the Point-of-Care into Study EDC Systems.” It’s clear that RWE can support these aims by layering additional information on top of trial-generated data. RWE/RWD can also be a critical input to protocol development to ensure the best possible trial design from the start.
#2. Creating diverse, equitable, and inclusive clinical trials is a bigger focus than ever, yet there is still much to do.
- In the opening plenary session, we heard from leaders associated with the Beacon of Hope Program
, a 10-year collaboration with 26 Historically Black Colleges and Universities (HBCUs), Novartis, Merck, Sanofi, the National Medical Association, Thurgood Marshall College Fund, and Coursera. The program establishes clinical trial centers of excellence at four Historically Black Medical Schools to bring trial opportunities to a more diverse set of patients and investigators, among other objectives. The group discussed the importance of not only designing trials with more thoughtful inclusion/exclusion (I/E) criteria and selecting more convenient sites, but also thinking about protocol design elements and the impact on patient retention. A trial that is designed to be ‘inclusive,’ but requires a significant amount of travel, office visits, and time off of work is not truly inclusive. As our industry continues to evolve our diversity, equity, and inclusion (DE&I) plans, we must think about all angles of DE&I and not simply I/E criteria. On the heels of the FDA’s April 2022 guidance for improving diversity in trials
, we anticipate we will continue to see a focus from technology partners on this topic, with many vendors exploring ways to use products and services to achieve DE&I goals more effectively and efficiently.
#3. Sites and sponsors need partners that will make their life easier rather than add burden.
- As the number of technology partners to choose from for all different elements of clinical trials increases, it’s critical that technology companies do not simply throw a solution ‘over the wall’ and hope for the best. Providing high-touch, personalized, and thoughtful product support from implementation through execution? can help ensure that the technology truly helps get to patient impact, sooner, rather than adding more work and risk.
#4. Interoperability is a must in order to accelerate research.
- Gone are the days of siloed clinical trial technologies. In order to create the most complete clinical dataset—and to do so quickly—it’s critical to enable data sharing across systems. Without establishing these connections, leveraging data to achieve even more impactful evidence will take longer and may never reach its full potential.?
#5. Automating outdated, manual data entry processes is becoming table stakes
- Much of today’s clinical trial data entry is done manually, which is a frustrating and error-prone process and delays the ability to start analyzing data sooner. It’s apparent that more and more technology providers are attempting to improve this key clinical trial process through systems that connect the EHR to the EDC for a particular study. While still in the earlier stages, it’s a clear area of opportunity to accelerate clinical research.?
To learn more about how Flatiron’s Clinical Research team is reducing burden, lowering costs, and accelerating clinical trials, reach out today: https://page.flatiron.com/clinical-research-contact
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