Assess whether RWE can replace or only supplement an RCT (21e820)

Situation

An FAERS cluster in a demographic the trials under-enrolled put RWE protocol that may not meet regulator expectations in front of clinical-development physician in an RWE group proposing a post-marketing study instead of a new RCT. This Pharma & Life Sciences / CMC and Development Pathways close is RWE can replace or from RWE protocol that may not meet regulator expectations, and the live options are RWE can replace, Only supplement an RCT.

Decision

Clinical-development physician in an RWE group proposing a post-marketing study instead of a new RCT must choose RWE can replace / Only supplement an RCT using RWE protocol that may not meet regulator expectations after an FAERS cluster in a demographic the trials under-enrolled.

Hypotheses to test

• An FAERS cluster in a demographic the trials under-enrolled is noise around an already-controlled CMC and Development Pathways process in an RWE group proposing a post-marketing study instead of a new RCT, given RWE protocol that may not meet regulator expectations.
• An FAERS cluster in a demographic the trials under-enrolled is the event in RWE protocol that may not meet regulator expectations that forces RWE can replace for clinical-development physician under Pharma & Life Sciences.
• RWE protocol that may not meet regulator expectations shows a one-file miss after an FAERS cluster in a demographic the trials under-enrolled, not a CMC and Development Pathways program failure.
• RWE protocol that may not meet regulator expectations cannot decide RWE can replace or yet after an FAERS cluster in a demographic the trials under-enrolled; hold is the only Pharma & Life Sciences close an RWE group proposing a post-marketing study instead of a new RCT can defend.

Analysis required

• Test a protocol deviation versus a safety signal versus a filing gap on RWE can replace or.
• Check whether RWE protocol that may not meet regulator expectations supports the labeled claim clinical-development physician would keep.
• Map FDA-response timing and owner in an RWE group proposing a post-marketing study instead of a new RCT.
• For this Pharma & Life Sciences CMC and Development Pathways file, read RWE protocol that may not meet regulator expectations against an FAERS cluster in a demographic the trials under-enrolled and write the one fact that would move RWE can replace or for clinical-development physician.