Investigational New Drug (IND) Enabling / Preclinical Development

Before any clinical trial can begin, the researchers must file an Investigational New Drug (IND) application with the FDA. The application includes the results of the preclinical work, the candidate drug’s chemical structure and how it is thought to work in the body, a listing of any side effects and manufacturing information. The IND also provides a detailed clinical trial plan that outlines how, where and by whom the studies will be performed.

The FDA reviews the application to make sure people participating in the clinical trials will not be exposed to unreasonable risks.

In addition to the IND application, all clinical trials must be reviewed and approved by the Institutional Review Board (IRB) at the institutions where the trials will take place. This process includes the development of appropriate informed consent, which will be required of all clinical trial participants.

Statisticians and others are constantly monitoring the data as it becomes available. The FDA or the sponsor company can stop the trial at any time if problems arise. In some cases a study may be stopped because the candidate drug is performing so well that it would be unethical to withhold it from the patients receiving a placebo or another drug.

Finally, the company sponsoring the research must provide comprehensive regular reports to the FDA and the IRB on the progress of clinical trials.

 

Continue to Phase 1 >