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Investigator-initiated clinical trials (IITs) provide companies with the clinical data to further scientific understanding of their drugs. IIT findings help to expand on- and off-label usage, reach new patient populations, generate data for publication and solidify relationships with key opinion leaders. Once considered an afterthought, IITs are now often regarded as critical pieces of product development strategy.

Reflecting this different mindset, many companies have established centralized IIT management groups and processes. While such efforts mark a giant step forward, all organizations still routinely confront challenges that range from slowdowns in the IIT-approval process to issues with trial oversight.

Investigator-Initiated Trials addresses such obstacles and provides solutions by outlining steps to refine IIT management efforts. Use this report to accomplish the following goals:

- Develop strategic thinking to align IITs with corporate strategy
- Compare timelines and best practices for IIT proposal evaluation and approval
- Improve ongoing IIT oversight
- Discover IIT management trends
- Benchmark structures and investments
- Examine profiles of 16 companies' IIT efforts

 

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