Abstract
Establish and perfect internal controls to capitalize on IIT opportunities
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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