Assess whether to drop a secondary endpoint that will dominate the AdCom

SITUATION In an RWE group proposing a post-marketing study instead of a new RCT, disproportionate reporting signal workbook is the evidence after a pediatric ethicist objecting to the proposed design. Clinical-development physician has to pick Proceed under protocol or Pause the pathway for this Pharma & Life Sciences CMC and Development Pathways close using disproportionate reporting signal workbook.

DECISION Clinical-development physician in an RWE group proposing a post-marketing study instead of a new RCT must choose Proceed under protocol / Pause the pathway / Escalate safety review / Hold using disproportionate reporting signal workbook after a pediatric ethicist objecting to the proposed design.

HYPOTHESES TO TEST 1. The population in disproportionate reporting signal workbook is the one a pediatric ethicist objecting to the proposed design named, so Proceed under protocol follows for this CMC and Development Pathways file. 2. The population in disproportionate reporting signal workbook is adjacent only to a pediatric ethicist objecting to the proposed design; Pause the pathway is the honest Pharma & Life Sciences call. 3. An RWE group proposing a post-marketing study instead of a new RCT already contained a pediatric ethicist objecting to the proposed design before disproportionate reporting signal workbook arrived; no new CMC and Development Pathways path. 4. Provenance on disproportionate reporting signal workbook after a pediatric ethicist objecting to the proposed design is broken; do not pick Proceed under protocol or Pause the pathway yet.

ANALYSIS REQUIRED 1. Map FDA-response timing and owner in an RWE group proposing a post-marketing study instead of a new RCT. 2. Trace CMC, labeling, or pharmacovigilance facts in disproportionate reporting signal workbook after a pediatric ethicist objecting to the proposed design. 3. Separate an isolated adverse event from a systemic quality issue. 4. For this Pharma & Life Sciences CMC and Development Pathways file, read disproportionate reporting signal workbook against a pediatric ethicist objecting to the proposed design and write the one fact that would move to drop a secondary for clinical-development physician.

RECOMMENDATION Choose Proceed under protocol / Pause the pathway / Escalate safety review / Hold on this Pharma & Life Sciences / CMC and Development Pathways packet (disproportionate reporting signal workbook after a pediatric ethicist objecting to the proposed design). The follow-on CMC and Development Pathways action is what clinical-development physician does next: implement the option, assign an owner, and log the missing fact.

COMMAND RETURNS - Bottom-line Pharma & Life Sciences option on to drop a secondary, then the evidence in disproportionate reporting signal workbook, then the action for clinical-development physician - Hypothesis scorecard against disproportionate reporting signal workbook: supported / rejected / untestable - Missing page in disproportionate reporting signal workbook after a pediatric ethicist objecting to the proposed design, if any - Regulatory or exam hook CMC and Development Pathways would cite