Exploratory IND

A traditional Phase I IND requires a very comprehensive and detailed application for any human research protocol for evaluation of a drug. In 2006, the FDA has instituted a new approach, called the Exploratory IND, to ease the application process as well as expedite the research progress. An exploratory IND is a clinical trial that is conducted early in Phase I, involves 

An exploratory IND containing the following information must be submitted to the FDA  

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Draft Guidance on Exploratory IND Studies Provides guidance on non-clinical and clinical approaches that should be considered when planning exploratory IND studies in humans Anon45... 

Anon., Guidance for industry, investigators and reviewers Exploratory IND studies, 2005, http //www.fda.gov/cder/guidance/6384dft.pdf... 

FDA, Guidance for Industry Investigators and Reviewers Exploratory IND Studies, April 2005, Available at http //www.fda.gov/cder. 

Figure 2.10. The microdosing strategy for candidate selection offers the greatest benefit when a stop-development decision is made. This is because the exploratory IND does not forego the submission of a traditional IND to continue testing in the clinic. (IND, Investigational new drug mths, months FIH, First-in-human clinical study Ph1, Phase 1 clinical studies Ph2, Phase 2 clinical studies.)...

FDA Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies, January 2006. Accessed February 1, 2006, at http // www. fda. gov/cder/guidance/7086fnl. pdf. 

Different criteria are proposed for so-called exploratory investigational new drug applications (exploratory IND). This is the case for clinical investigations in which volunteers will receive a low number of doses of an investigational drug at... 

U.S. Food and Drug Administration, Guidance for industry, investigators, and reviewers. Exploratory IND studies, 2006. 

While an exploratory IND protocol is approved and monitored directly by the FDA, the RDRC studies are approved and monitored by the committee itself and the FDA monitors it only indirectly. 

The number of subjects is normally limited to 30 in the RDRC, whereas there is no limit on the number of patients in exploratory IND, although it should be small. 

In the RDRC, if subjects of age less than 18 or more than 30 subjects are used, a special summary report must be submitted to the FDA. Also women of childbearing age must declare in writing the absence of pregnancy to participate in the RDRC study. Under exploratory IND, no such restriction exists expect that each case is individually evaluated. 

The RDRC limits the radiation doses to subjects, whereas in an exploratory IND there is no such limit. 

Sarapa, N. (2007) Exploratory IND a new regulatory strategy for early clinical drug development in the United States. Ernst Sobering Res. Found. Workshop 59, 151-163, 116b. 

Administration, US Food and Drug. Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies including Human Microdose Studies, 2006. http // www.fda.gov/CDER/guidance/7086fnl.htm. 

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