Federal law requires that investigational drugs entering the clinical trial system file an approved marketing application before being transported or distributed across state lines. Since trial investigators want the drug distributed in many states, they must seek exemption from this legal requirement. The Investigational New Drug Application (IND) is the means by which the sponsor obtains this exemption from the Food and Drug Administration.
As long as a drug is in preclinical development, the sponsor=s primary goal is to determine whether the product is reasonably safe for use in humans, and whether it exhibits enough anti-cancer activity to justify further consideration for commercial development. Once a viable drug candidate is identified, the sponsor focuses on collecting data that will establish that the drug will not cause unreasonable risk to humans in Phase I clinical trials.
The FDA’s role begins when the drug=s sponsor has screened the molecule for acute toxicity and anti-cancer activity in animals, and wishes to test its therapeutic value in humans. It is at this point that the molecule changes in legal status and becomes a drug subject to the requirements of the drug regulatory system.
An IND application must contain the following:
- Preclinical data on toxicity and anti-cancer activity in animals showing that the drug will be reasonably safe for testing in humans.
- Information regarding the composition of the drug, its manufacturer and the controls used to ensure the drug can be produced in adequate supply and with the same consistency.
- Detailed protocols for proposed clinical trials.
- Qualifications of the investigators who will oversee the administration of the drug in the clinical trial setting.
- Commitment to obtain informed consent from trial participants.
- Commitment to obtain a review of the study by an institutional review board (IRB).
- Commitment to adhere to investigational drug regulations.
Once an IND is submitted, the sponsor must wait at least 30 days before initiating Phase I trials so that the FDA can review the application thoroughly.