Investigator-initiated research plays a big role in working with industry to run trials that address unmet therapeutic needs that can lead to new therapeutic candidates, improved therapies and the discovery of new drug indications. With the increasing number of investigator-initiated trial (IIT) requests coming into life science organizations, there is also a higher demand to optimize the IIT portfolio management taking into consideration financial, logistical and regulatory/legal aspects. Although investigator-initiated research provides a strong avenue for achieving scientific benchmarks, sponsored research — also called research collaborations — is another type of joint effort in which investigators and industry work together to run trials and share responsibility and ownership of trial designs and outcomes.
The 21st Investigator-Initiated Trials and Research Collaborations Symposium covers all aspects of IITs, including the use of performance measures to optimize trials, considerations for running single vs. multicenter trials, best practices for understanding and fulfilling the expectations of industry and sponsors, structured data, analytics and systems management impact on IITs, and ways to foster compliance and strengthen studies for newer sponsor-investigators. In addition, this summit speaks to the similarities and differences between research collaborations and IITs, including responsibilities; ownership of the research, royalties and publication rights; and, most crucially, when it’s viable and appropriate to support each type of collaboration.
This conference is designed for representatives from academic institutions; hospitals; and pharmaceutical, biotechnology and medical device companies whose responsibilities involve: