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No. 6: June 14-18, 2010

Conducting a Multi-Site Trial with Individual IND Applications

Dr. Porter is an opinion leader in his medical specialty. He has an idea for a clinical trial using a lawfully marketed drug for an unapproved indication at a higher than recommended dose. In order to complete the study with the statistical power necessary to prove the hypothesis, he needs more patients than those available at his institution.

Dr. Porter contacts four colleagues at different institutions where the patient populations for this particular condition are larger. His colleagues are eager to participate as principal investigators at their respective institutions.

Dr. Porter knows this study will require the submission of an Investigational New Drug (IND) application. He works with the regulatory support staff in his institute’s clinical trials office.

The IND is completed and ready to be submitted to the Food and Drug Administration. It contains Form FDA 1571 naming Dr. Porter as the IND holder. It contains five Forms FDA 1572, one for each of the five principal investigators.

The legal staff reviews the agreements with the other four institutions and informs Dr. Porter that the institution does not want him to take on the regulatory responsibilities as the IND sponsor of a multi-site study.

Dr. Porter cannot complete this study without the participation of the other sites, and those sites are eager to participate.

Dr. Porter submits his investigator-initiated IND application as a single site to the FDA. Upon receipt by the FDA it is assigned an IND number. After the 30-day safety review, the FDA determines that it is safe to proceed.

Dr. Porter submits a letter to the FDA authorizing the FDA to refer to his IND in support of the IND applications to be submitted by each of his four colleagues. He sends a copy of this letter to his colleagues for inclusion in their own IND applications.

These IND applications are quite simple. Each consists of a cover letter, Forms FDA 1571 and 1572, the protocol and the letter authorizing cross-reference to Dr. Porter’s IND.

Using this approach, each researcher is the sponsor-investigator of his/her own IND application. The protocols are identical and the statisticians at Dr. Porter’s institution can pool the data to obtain the number of subjects needed for statistical significance. Each IND sponsor-investigator must comply with the regulations for both sponsors and investigators. Dr. Porter does not have to take on the responsibility as the IND sponsor of a multi-site clinical trial.

The Code of Federal Regulations describes IND applicability, responsibilities, records, and recordkeeping for sponsors and investigators [21 CFR 312]. The FDA has issued guidance documents that cover the topics of clinical trial monitoring, responsibilities of principal investigators, and good clinical practice (GCP).

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.

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