Prime Minister Winston Churchill famously remarked at a pivotal but early point in World War II, “Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”
As far as J. Kaitlin Morrison, PhD, director of sponsored clinical research at the University of North Carolina Lineberger Comprehensive Cancer Center, is concerned, Churchill might have been talking about the period after a regulated entity gains U.S. Food and Drug Agency (FDA) approval for an Investigational New Drug (IND) application.
Unfortunately, Morrison says, too many in the industry think their major work is done when they get the IND approval. “It’s honestly the beginning” of the process and challenge, she says. A common mistake, she notes, is for teams to believe the agency’s IND thumbs-up is a “carte blanche” of approval for trial conduct going forward. Not so, she stresses.
In fact, Morrison says, if running a clinical trial is thought of in terms of writing a novel, getting IND approval is more like “finishing the forward.”
Morrison advocates looking at online FDA Warning Letters and case studies of trials gone wrong to learn from the sometimes dangerous mistakes others have made after IND approval. She likes to work with groups and examine different scenarios to see what kind of mistakes can turn into Warning Letters, and how effective procedures can mitigate problems and avoid regulatory headaches.
Further, drug developers shouldn’t assume they can easily shortcut around the IND process, Morrison says. It’s important to be very clear on FDA’s IND exemption criteria, she notes.
A study must meet all the following conditions to be exempt from IND requirements:
- It is not intended to support FDA approval of the drug for a new indication or significant change in the labeling.
- It is not intended to support a significant change in advertising.
- It is conducted in compliance with regulations governing institutional review boards and informed consent procedures.
- It is conducted in compliance with regulations governing the promotion of and charging for investigational drugs.
- It does NOT involve a route of administration, dosage level, or use of a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product.
Author: Michael Causey