Benchmarking IIS Strategy: Investigator-Initiated Studies for Pre-Approval Compounds

• IIS for Pre-Approval Compounds
• Insights from Non-Adopters

• Which types of IISs are considered for pre-approval compounds - and in which phases of compound’s clinical development?
• How frequently do benchmark organizations select proposals for each study type for pre-approval compounds?
• How important are each of the listed strategic factors in benchmark organizations’ decision to support IISs for pre-approval compounds?
• How effective are each of the listed strategies for mitigating common risks associated with IISs for pre-approval compounds?
• Why have certain benchmark organizations decided not to consider IIS proposals for pre-approval compounds?
• Which group(s) in benchmark organizations contributed to the decision to not support IISs for pre-approval compounds?

• IIS Risk Mitigation for Pre-approval Compounds:

• Most important tactic: Use explicit contracting terms around IP and safety reporting (73% total benchmark class)
• Very important tactic: Confining proposal review to tight area of interest (53% total benchmark class)

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