FDA Counsels Sponsor-Investigators on Submitting INDs

The FDA has issued draft guidance spelling out how to prepare and submit an IND if the sponsor is an investigator and not a commercial entity — saying sponsor-investigators often lack the regulatory know-how to submit a proper IND.

Many of the elements in last week’s guidance are the same as those drugmakers would be expected to include in their IND applications, such as the name of the drug and its active ingredients, its pharmacologic class and structural formula, the dosage form and formulation, how the sponsor plans to administer it and the objective of the proposed clinical trial.

Sponsor-investigators should also provide a short summary of any human experience with the drug to be studied, the guidance says. This information could come from a letter provided by a commercial sponsor allowing the FDA to cross-reference its IND with that of the sponsor-investigator. If the drug is already on the market, nearly all of the necessary information can come from the drug’s labeling, the FDA says.

The investigational plan should justify the proposed trial, its schedule, the specifics on indications and dosing, and the patient populations involved. If the drug’s toxicology suggests the possibility of serious adverse events, those should be included, too.

If the drug is on the market anywhere in the world, the sponsor-investigator must also provide real-world safety information for the proposed trial.

The guidance also details what sponsor-investigators should include in protocols for various phases of clinical trials. For example, protocols for Phase II and III studies should cover all aspects of the trial, including the number of subjects, inclusion and exclusion criteria, investigational methods and control groups, how the dose was determined and which procedures or tests will be used to measure the drug’s effect.

For all phases, applications for drugs currently marketed in the U.S. and drugs under INDs must include the label for the immediate packaging and an environmental assessment or statement requesting exemption. For drugs without marketing approval or INDs, the FDA asks for more complete chemistry, manufacturing and control information.

Comments on the draft are due July 15 to docket no. FDA-2015-D-1484. Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators is availableat www.fdanews.com/5-15-FDA-INDs.pd. — Lena Freund