Expert: Sponsor Investigators Need to Beware of Regulatory Landscape

Investigators contemplating their own clinical trials need to understand the regulatory framework of investigator-initiated studies and what it means to be a sponsor investigator before wading into the water, a legal expert says.

Linda Coleman, director of regulatory affairs and general counsel at Quorum Review IRB, said that, all too often, investigators think sponsoring a clinical trial is no different than running a clinical practice. But that’s not the case: there are specific regulations for investigator-initiated research that practitioners need to be aware of, she said.

Principal investigators interested in initiating a trial need to understand the definition of a clinical investigation and investigators’ and sponsors’ responsibilities under 21 CFR and various guidances. They also need to understand the role of a sponsor investigator as defined in the regulations — an individual who initiates, conducts and oversees a clinical investigation.

“Whether it’s a device study or a drug study, the obligations of a sponsor-investigator include those of an investigator and those of a sponsor,” explained Coleman. The regulations and guidances aren’t available in aggregated form, but investigators can learn about them through the Collaborative Institutional Training Initiative, or CITI, program and other resources, and by consulting regulatory experts, she said.

Investigator-initiated studies are critical to medical research as companies often avoid studies of off-label use of drugs, orphan drugs and cutting edge-therapy because they’re not sufficiently profitable, Coleman noted. The past decade has seen the release of a number of FDA guidances and other helpful tools for sponsor investigators — underscoring their growing role in the medical research arena, she said.

But while there are many experienced and well-qualified sponsor investigators, Quorum has worked with some who lack the experience in designing protocols and regulatory knowledge to conduct trials on their own, Coleman observed.

Running a clinical trial is a large undertaking. In order to pull it off successfully, you’ll need the tools that FDAnews’ Clinical Trials Disclosure and Transparency Summit will provide. Sign up today.