The Food and Drug Administration in a new framework says it will use a three-step approach to determining how to best use real-world evidence in drug approvals.
According to a RAPS.org report, the agency says it will consider the following:
- Whether the real-world data are fit for use;
- Whether the trial or study design for RWE generation can deliver sufficient evidence to answer or help answer regulatory questions; and
- The integrity of the study conduct and whether it complies with FDA mandates.
“FDA intends to use this three-part approach to evaluate individual supplemental applications, as appropriate, and more generally to guide FDA’s RWE Program,” the framework states.