While many clinical trials are initiated by industry sponsors (like pharmaceutical companies), other trials originate within a research site. When a researcher has an idea for a study they’d like to conduct, called an investigator-initiated trial or IIT, the researcher is in charge of creating, coordinating, and carrying out the IIT. A researcher may wear many hats in an IIT, including as an investigator, sponsor, or sponsor investigator, with each role having specific U.S. Food & Drug Administration (FDA) regulatory requirements. This session aims to describe the way regulatory responsibilities are assigned in an IIT vs. an industry-sponsored clinical trial and provide insight on what researchers can expect and best practices when conducting IITs.
Sierra Clark - Industry Contracts Manager - University of California San Francisco
Lin Feng - Clinical Research Coordinator - UBMD Orthopaedics & Sports Medicine
Matthew Porteus - Professor - Stanford University
Julie Tibbets - FDA Practice Chair - Goodwin Procter LLP
- Define IITs, with a focus on those that involve an investigational medical product and are regulated by the U.S. Food and Drug Administration
- Describe the way regulatory responsibilities are assigned in an IIT vs. an industry-sponsored clinical trial
- Expectations and best practices when conducting IITs