What you should know:
– Today Science 37 published a new report that suggests a momentous change in the way clinical trials are conducted.
– For the first time, more research sponsors and CROs plan to run agile / hybrid clinical trials than ever before. The findings show that the vast majority or 77% of respondents plan to conduct an agile clinical trial over the next 12 months, compared with 59% in the previous 12 months.
Science 37 Holdings, Inc. (Nasdaq: SNCE) (“Science 37”), a pioneer of decentralization and the LA-based operating system for today’s most agile clinical trials, has released new data suggesting that the clinical research industry has achieved a fundamental shift in the way clinical trials are conducted, as sponsors and CROs report that they plan to conduct more agile (or hybrid) clinical trials in 2022 than traditional site-based studies.
Background to the report
The findings are the result of a study of sentiments among 127 senior clinical research executives in September and October 2021. Nearly eight of the 10 respondents said they planned to conduct an agile clinical trial in the next 12 months. In contrast, only seven out of 10 said they planned to conduct a traditional site-based study over the next 12 months.
Definition of agile clinical trials
The use of decentralized tools and methodologies is increasing. With these advances, patients will be able to participate from home, a place, or a combination of home and place; and suppliers may participate inside or outside the facility. This symbiotic clinical trial or “agile clinical trial” requires: The ability to activate any provider and any patient, regardless of facility; a network of patient communities, telemedicine researchers, mobile nurses and remote coordinators, all with a flexible operating system to navigate seamlessly between the site and the outside.
Key findings
In addition to documenting this fundamental change, the survey data also paints a vivid picture of the decentralized clinical trial (DCT) landscape for next year, suggesting significant increases in DCT activity in multiple areas. therapeutic and study phases. Among the findings:
– 46% of respondents expect to perform an oncology study using DCT next year, compared to 35% the previous year, making oncology the most common category of DCT.
– Oncology, CNS, rare diseases and immunology should be seen the highest adoption in the use of DCT.
– The report suggests significant increases in DCT activity in phase II, III and IV studies.
– We also expect to see large increases in the deployment of most individual DCT components, especially eConsent, telemedicine, mobile nurses, and remote locations in a hybrid model.
– The 3 main perceived benefits of DCT are better patient experience, better patient retention, and faster recruitment.
– The three main perceived challenges of DCT are the integration of traditional sites with DCT, lack of internal capacities and regulatory concerns.
“The power of increased decentralization is becoming undeniable as more sponsors benefit from faster enrollment, greater retention, and greater diversity,” said David Coman, CEO of Science 37. “Leveraging Science 37’s operating system, our customers enable it to be much more agile. Clinical trial designs that achieve these benefits while significantly reducing patient burden and providing more universal access to patients and providers, anywhere “.