By James Perhach, Director of Clinical Development & Research on Oct 4, 2017 9:00:00 AM
Generally speaking, if the intent of a clinical trial is to determine the safety and efficacy of a new drug, or changes to an existing drug, then IND submission is required. Filing an IND is quite complex and time consuming, so before starting the process of submission, you’ll want to ensure that it is absolutely necessary. Here we simplified the guidelines to help you determine if you are required to file an IND for your clinical trial and also provide some additional resources for follow-up on more details.
- The clinical trial is intended to promote or commercialize the drug/biologic product
- The drug/biologic product is not lawfully marketed in the US
- The intent of the investigation is to report the findings to the FDA with respect to a change in:
- a new indication or any other significant change in the labeling of the drug/biologic
- advertising of the drug/biologic
- the route of drug/biologic administration
- the drug/biologic dosage level
- the applicable patient population
- any other factor that significantly increases, or decreases, the acceptability of the risk associated with the use of the drug/biologic product
Situations always arise when clinical trial investigations may be exempt from IND submission. For example, if there is significant information about treatments already in the literature, then an IND may not be necessary. Each clinical trial is unique, so the best thing to do, is to do some background research using the tips below and discuss with your team on appropriate next steps.
1. For a more detailed description to determine whether your clinical trial may be conducted without filing an IND, we refer our investigators to the FDA’s 20-page document, Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs)— Determining Whether Human Research Studies Can Be Conducted Without an IND.
2. Seek advice from the FDA Review Division. You can speak with the appropriate person according to the therapeutic area of the proposed trial and seek advice. In some cases, FDA staff may be able to provide this advice through informal communications (e.g., phone conversation, e-mail
3. In cases where an informal communication is not sufficient, FDA staff may request that you submit a summary of your proposed investigation with a “IND Exemption Request” for FDA review before providing advice.