W 43: Pooled Continued Access Protocol for Oncology Experimental Therapeutics No Longer in Development
Sr Director, Head of Clinical Science
Editas Medicine United States
Experimental agents that have been discontinued from development often still have patients that are on study and receiving long term benefit. Although it is a fortunate problem to have, managing these patients becomes challenging since the development of the agent has ended.
To provide patients with access to therapy, clinical trials traditionally remain open collecting data long after achieving primary endpoints and completing final study reports. The associated resources, operating costs and regulatory requirements can continue for years for these clinical studies.
We have designed and executed a single, master protocol (NCT02632994) which allows multiple experimental agents that are no longer in development to be rolled into single agent addenda serving as study “arms.” This provides patients continued access under one protocol instead of under multiple protocols in various programs. By utilizing this novel protocol approach, there is a significant cost/ resource savings and improved oversight and management of these cancer patients. This approach allows for continued patient benefit through uninterrupted supply of the experimental agent, and ensures appropriate, required safety monitoring and data reporting, while reducing costs associated with clinical studies.
This achieves a balance of meeting patient needs while allowing valuable resources to be redirected toward more promising experimental assets currently in development.