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No. 7: June 21-25, 2010

Question: When is an IND necessary?

Question:

If we want to test a medication for a use that is already approved vs. another medication/placebo, or test an approved medication in an off-label use, when do we not need IRB clearance/involvement? Also is there a maximum number of patients we can enroll in this type of clinical research?

FDA regulations discuss the applicability of an IND for marketed drugs. They state that the use of a drug lawfully marketed in the US is exempt from the IND requirements if all the following apply:

• The results are not intended to be submitted to the FDA to support a new indication or change in labeling;

• The results are not intended to be reported to FDA to support a change in advertising;

• The study does not involve a route of administration or dosage level or use in a patient population or other factor that increases the risks (or that the acceptability of the risks) associated with the use of the drug product;

• IRB review and approval is obtained and informed consent is obtained;

• The drug is not promoted as safe and effective for the study indication and there is no charge for the drug without prior authorization from FDA to do so.

The brief description in your question indicates that this is research and not clinical practice. In clinical practice you would not randomly select which patients receive treatment drug and which patients receive placebo. Anytime research is conducted on human subjects IRB review and approval is required as is obtaining informed consent from the subjects.

There are many factors that affect the number of subjects needed to assure statistical validity of a research study. It is best to involve a biostatistician to assist in making that determination.

References:

* 21 CFR 312.2 IND applicability
* 21 CFR 312.7 Promotion of an investigational new drug
* 21 CFR 56 Institutional review boards
* 21 CFR 50 Protection of human subjects

Comments by Harvey M. Arbit, PharmD, MBA, the president of Arbit Consulting, LLC. He specializes in FDA regulatory affairs related to investigator-initiated IND and IDE research.