Drugs

More FDA Clarity Needed on RWE Studies: Attorney

Attorney Kellie Combs (Ropes & Gray) says that while FDA wants to work with industry on incorporating elements of real-world evidence (RWE) in drug development programs, many in industry have said it’s not likely that industry will start to conduct a lot of RWE studies until there is significantly more clarity from the agency on what it thinks about the studies. She says that was one of the key takeaways from a 7/11-7/12 FDA public workshop on RWE.

“FDA may be willing, for example, to discuss study design and work with sponsors,” Combs said in a podcast on the workshop, “but as a practical matter there may be significant back-and-forth between the sponsor and the agency before any sort of clarity or agreement is reached on study design, use of RWE, and other issues that are critical to drug development in clinical studies, like endpoint selection. Many big players in industry may ultimately decide, at least in the short-term then, that it’s more efficient to do a traditional clinical study until we get the clarity that we’re looking for from FDA. At this point, we haven’t seen a significant number of products approved, or supplemental approvals, involving the use of RWE, but we have seen some.”

Also reporting on the workshop, attorney Sarah Blankstein said that so far use of RWE in drug approvals has taken place in three ways: for safety signal evaluation, to develop a synthetic control arm, or through an observational study to support a new indication for an already approved drug.

Combs noted that in some of the approvals using RWE, manufacturers have worked with health technology companies to develop the data sets. Blankstein said she expects that trend to continue.

The two also discussed how companies have made use of RWE studies outside the FDA regulatory approval and submissions context, as part of product commercial communications.

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