THREAD: To facilitate access to promising but experimental drugs for #COVID19 under compassionate use FDA can implement a standardized protocol that designated drugs fall under. It would expand patient access, reduce provider burdens. One protocol for multiple promising therapies
FDA can work with manufacturers to develop a large scale #COVID19 expanded access program. An IND could cover multiple hospitals and patients admitted to that hospital. 2/n
A national IND for compassionate use could specify the available drugs, how to access them, general inclusion criteria, and guidance for limited key data collection. 3/n
This would eliminate the need for individual compassionate use requests and approvals, which is burdensome in the setting of a major public health crisis. It would help our overburdened doctors access potential treatments. 4/n
We could make limited data collection as efficient as possible, leveraging the compassionate use to help inform (where possible) questions of safety/benefit. It can use hospitals’ existing patient record system; streamline information into a standard informed consent document 5/n
Including all drugs meeting a certain designation for potential benefit in one large, standard compassionate use program can: Reduce burden, facilitate timely access, give manufacturers one door to go through to offer availability, and promote access for patients without options.
