Clinical Trials Initiative

FDA clinical trial IND

When proposing an expanded access IND application for treatment of groups (or populations) of patients, an applicant should ensure that their proposal meets the criteria for expanded access applications described in the Expanded Access IND Application: Overview. As mentioned elsewhere in this module, FDA regulations allow access to investigational drugs for treatment purposes for two categories of groups of patients:

  • intermediate-size patient populations (n >1), and
  • larger populations for use of the drug under a treatment protocol or treatment IND application

An IND application intended for treatment of an intermediate-size patient population should be clearly identified as “Expanded Access Submission- IND Application for Intermediate-Size Population”. An IND application intended for treatment of a large-size population (i.e. widespread treatment use) should be clearly identified as “Expanded Access Submission-Treatment IND Application”. An applicable box in Section 12 on Form FDA 1571 (PDF - 830KB) should be checked in each case. The suggested format for expanded access IND applications intended to treat populations of patients may be found in Expanded Access IND Application: Contents and Format.

Sponsors of expanded access IND applications have the same Investigators’ Responsibilities as sponsors of IND applications intended for clinical investigations. The procedures for safety, annual, and other IND Application Reporting for expanded access IND applications are similar to those for investigational IND applications. The requirements for mandatory IND Application Safety Reporting are the same as for all other IND applications.

Additional considerations for IND applications intended for treatment of patient populations are discussed below.

IND applications for intermediate-size patient populations

FDA may ask sponsors of multiple applications to consolidate expanded access under one application when the agency has received a significant number of requests for individual patient expanded access to an investigational drug for the same use.

Submission of an expanded access IND application for a group of patients would be appropriate in any of the following situations:

  • The intended investigational drug is not being developed. The drug is not being developed, for example, because the disease or condition is so rare that the sponsor is unable to recruit patients for a clinical trial.
  • The intended investigational drug is being developed and studied in a clinical trial, but patients requesting the drug for expanded access use are unable to participate in the trial. For example, patients may not be able to participate in the trial because they have a different disease or stage of disease than the one being studied or otherwise do not meet the enrollment criteria, because enrollment in the trial is closed, or because the trial site is not geographically accessible.
  • The intended investigational drug is an approved drug product that is no longer marketed for safety reasons or is unavailable through marketing due to failure to meet the conditions of the approved application.
  • The intended investigational drug contains the same active moiety as an approved drug product that is unavailable through marketing due to failure to meet the conditions of the approved application or a drug shortage.
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Does the European clinical trials directive really improve clinical trial approval time?

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