FDA Releases Guidance for Clinical Trial Sponsor-Investigators

New guidance issued by the US Food and Drug Administration (FDA) instructs clinical trial sponsor-investigators on how to complete an investigational new drug application (IND)—an application used by FDA to approve the start of a new trial.

As FDA notes at the outset of the new draft guidance document, Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators, "Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process."

The guidance document is therefore intended to act as a basic overview of the IND process with an eye on individual researchers investigating new uses for either an approved or investigational drug.

FDA's guidance goes on to explains the basics of 21 CFR 312—the federal regulation governing IND submissions.

For example, FDA provides an overview of the essential elements of an IND submission, including information about the sponsor, a summary of the investigational drug product and its risks, the clinical trial protocol and a summary of previous clinical trial results involving the drug.

The guidance, FDA notes, is not intended for use by sponsors or investigators "seeking to evaluate a drug for commercial purposes (i.e. seeking market approval or licensure) and thus does not focus on certain regulatory requirements that involve exchange of information or materials between a sponsor and investigator."

Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (FR)