Assess whether RWE can replace or only supplement an RCT (1ac956)

Situation

The desk packet is advisory-committee question list that exposes a weak secondary endpoint after a DSMB note on an imbalance that is not yet a signal. Clinical-development physician in an RWE group proposing a post-marketing study instead of a new RCT has to name RWE can replace or Only supplement an RCT for this Pharma & Life Sciences CMC and Development Pathways file.

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 advisory-committee question list that exposes a weak secondary endpoint after a DSMB note on an imbalance that is not yet a signal.

Hypotheses to test

• Authorize RWE can replace now; advisory-committee question list that exposes a weak secondary endpoint already has the discriminator after a DSMB note on an imbalance that is not yet a signal.
• Keep Only supplement an RCT in force until advisory-committee question list that exposes a weak secondary endpoint is completed after a DSMB note on an imbalance that is not yet a signal for clinical-development physician.
• Treat advisory-committee question list that exposes a weak secondary endpoint as RWE can replace because both readings appear after a DSMB note on an imbalance that is not yet a signal.
• Refuse a Pharma & Life Sciences close: clinical-development physician does not have the page RWE can replace or turns on in advisory-committee question list that exposes a weak secondary endpoint.

Analysis required

• Check whether advisory-committee question list that exposes a weak secondary endpoint 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.
• Trace CMC, labeling, or pharmacovigilance facts in advisory-committee question list that exposes a weak secondary endpoint after a DSMB note on an imbalance that is not yet a signal.
• For this Pharma & Life Sciences CMC and Development Pathways file, read advisory-committee question list that exposes a weak secondary endpoint against a DSMB note on an imbalance that is not yet a signal and write the one fact that would move RWE can replace or for clinical-development physician.

Recommendation