How the data will be used

Another consideration when determining whether or not an IND is needed has to do with the way that the data collected from the study will be used. This is important, because the results of your study may be used to change the labeling or marketing of a drug.

Also, if your intention (or someone supplying funds) is to influence prescribing habits, there is a possibility that an IND may be required. In both cases, a larger population of patients could be placed at risk.

Interestingly, even if the on-site investigator is not intending to submit the results of the study to the FDA, the sponsor may have intentions on doing so. If this is the case, an IND may still be required. For example, an investigator-initiated study is being supplied with funds and/or supplies of the study drug by a pharmaceutical company. If the contract with the company states that they have the ability to file the data with the FDA, then that study needs to be conducted under an IND.