How the data will be used
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.