Frequently Asked Questions About INDs
Do I need to submit an IND application if I study healthy participants?
A study involving healthy participants does not eliminate the possibility that the study may need to be conducted under IND regulations. The FDA may require an IND application if there are concerns about the safety of the product, or if the outcomes are not consistent with a structure or function claim. Only the FDA can determine whether proposed research requires an IND application.
If my trial requires an IND, can the product still be sold as a dietary supplement?
Submitting an IND application for a study that involves an existing dietary supplement may not affect the ability to continue marketing the product as a dietary supplement. However, if the product has been investigated in a clinical trial conducted with an IND number before the product was marketed as a legal dietary supplement, the ability to market the product as a dietary supplement in the future may be adversely affected.
If my study involves a population with a disease, will an IND application always be required?
It is commonly assumed that if a study is conducted among a population with a disease, an IND application will automatically be required. However, this has not always been the case for research supported by NCCIH. The FDA’s determination depends on additional factors regarding the product and the outcomes being collected in the study.
If a product has Generally Recognized As Safe (GRAS) status, is an IND application ever needed?
A widely held misconception is the assumption that any product that has GRAS status does not need an IND application. This is not true, because the FDA primarily considers the intended use for the product rather than the product itself when making an IND determination. If a clinical trial tests a product classified as GRAS for its ability to treat, prevent, cure, mitigate, or diagnose a disease condition, an IND application may be necessary. Only the FDA can determine whether proposed research requires an IND application.
If the FDA provides a waiver, can an Institutional Review Board (IRB) still require an IND application?
Some investigators believe their IRB has a significant role in dictating whether a study needs to submit an IND application. In fact, the decision is made entirely by the FDA. An IRB may have questions about a study and suggest an IND application is needed. However, it cannot force the FDA to accept an IND submission for any study. In general, documentation from the FDA about whether an IND application is needed should resolve any questions an IRB may have.
Does it make a difference to the FDA if an IND application has an industry sponsor or an academic sponsor?
Some academic investigators believe industry sponsors of INDs receive preferential treatment from the FDA. Conversely, some industry investigators believe academic sponsors of INDs experience fewer difficulties submitting an IND. The FDA’s evaluation of the IND application depends much more on the nature of the study, the novelty of the product, and the intended use of the data than on the type of sponsor. For example, will the company use the results from the research to pursue a formal request for a drug claim in a New Drug Application, or will it use the data from the trial in marketing materials to make a drug claim? The FDA considers commercial and research IND applications to be different categories.
If I’m only measuring pharmacokinetic outcomes, do I need to submit an IND application?
Your research question and the safety of the product may affect the answer to this question. Because the purpose of an IND application is to ensure participant safety, the sample collection method may also be important. Using a stent to collect blood samples or a tracer for imaging poses risks; collecting urine samples does not. The intended use of the product—such as prevention, treatment, or cure—may also affect the FDA’s decision, as does the study’s population. Only the FDA can determine whether proposed research requires an IND application.
What information do I need to include in my NCCIH application about the IND status?
NCCIH requires that grant applications include information about whether the FDA requires an IND application for a proposed clinical trial. In their NCCIH applications, investigators should describe any communications they have had with the FDA. If an IND application is required, investigators should provide a timeline for submitting the IND application and for resolving any clinical holds. The IND application does not need to be submitted at the same time or before the NCCIH application. However, NCCIH will not make an award until the IND application has been submitted and all clinical holds are resolved.
Should I request a pre-IND meeting?
Both research and industry IND sponsors can request a pre-IND meeting with the FDA, if desired. A pre-IND meeting is not required by the FDA to submit an IND application. The pre-IND meeting is typically requested when an investigator or industry sponsor wants to discuss plans for a series of clinical trials on a product that may lead to a New Drug Application to secure approval for a specific indication. During the pre-IND meeting, the FDA may provide guidance on the plan for clinical trials leading to a New Drug Application submission.