Worthy of Attention and Discussion

---

Noteworthy article regarding innovations to alleviate “pandemic-induced protocol deviations” in oncology studies that may yield long-term changes for these trials going forward. While providing safeguards to ensure safety and data integrity, FDA is working with sponsors to implement many innovations to reduce the impact of the pandemic on clinical studies. Among these are the use of telehealth for virtual patient monitoring, the use of real-world evidence (RWE) to support regulatory decision making, the use of digital platforms for patient enrollment, and the shift of clinical operations to community-based settings. It will be interesting to see how routinely these clinical practices are incorporated into oncology studies post-pandemic.

Read more here