The Politics of Investigator-Initiated Trials

By Jennifer Dennis-Wall, Ph.D.

Many clinical trials are initiated by a pharmaceutical company in order to generate data to submit to the FDA for drug approval. Investigator-initiated trials (IITs), on the other hand, are conceived by a clinician and not by the company that plans to sell the drug or device under study. IITs present a way for post-marketing, real-world data to be added to a drug or device’s portfolio without the sponsor initiating the research. IITs can also identify new uses and indications for drugs and devices, whether they are already approved or are still pre-market.

Everyone can agree on the fact that more research, and especially real world evidence, is helpful for advancing the field of medicine, but not everyone is always in favor of IITs.