The FDA last week issued suggestions on how researchers can evaluate the promise of new laboratory discoveries.
The agency said its goal in doing so is to improve the process for bringing safe and effective drugs for potentially serious and life-threatening diseases, such as cancer, heart disease and neurological disorders, to the market.
In guidance documents, the FDA laid out specific approaches for researchers planning to conduct very early clinical studies in people and offered approaches for performing appropriate safety testing and producing small amounts of drugs safely.
These changes will enable medical researchers to evaluate much more efficiently the promise of scientific advances discovered in their laboratories, the FDA said.
“Currently, nine out of 10 experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies,” said Mike Leavitt, Health and Human Services secretary. “The recommendations announced will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs.”
However, FDA acting commissioner Andrew von Eschenbach explained, “rapid does not mean reckless. There is no compromise … on the standards we apply.”
“One of the biggest barriers research and academic institutions face is the ability to get discoveries made in the lab into clinical testing,” von Eschenbach added. “The new Exploratory IND guidance emphasizes the flexibility available to researchers when conducting early clinical testing of these cutting-edge treatments. As we enter the era of personalized medicine, these exploratory approaches enable scientists to take full advantage of new technologies to target the development of more individualized therapies.”
The suggestions issued are part of the agency’s Critical Path Initiative, introduced in 2004, which aims to improve the efficiency and safety of drug development.