FDA looks to streamline early research
pharmafile | January 19, 2006 | News story | Research and Development |Â Â Â
The FDA has unveiled plans to allow more small-scale exploratory studies of drugs in humans before formal phase I studies begin, a move it hopes will cut time and effort lost when candidates fail in early testing.
Announcing the initiative the FDA acting commissioner Andrew von Eschenbach said: "Consider just one stark statistic: Today, nine out of 10 compounds developed in the lab fail in human studies. They fail, in large part because they behave differently in people than they did in animal or laboratory tests."
The guidance called Exploratory IND Studies and INDs-Approaches to Complying with CGMP During Phase I is part of the regulators ongoing drive to modernise and improve the drug development process.
The FDA says small-scale studies in just a few people, with low doses of the drugs will not represent a high risk for patients, but will help uncover potential problems earlier.
The regulator says all this can be done within existing regulations, and is alerting the industry and other researchers to this option.
"The recommendations announced today will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs," said US health secretary Mike Leavitt.
In addition to promoting existing opportunities the FDA is now reducing the regulation of good manufacturing practice for phase I trials.
"The problem is that researchers conducting very early studies were required to follow the same manufacturing procedures as those companies that mass produce products for broad scale distribution," said Janet Woodcock, FDA deputy commissioner for operations.
"These requirements are so burdensome for early phase I studies that many leading medical research institutions have not been able to conduct these studies of discoveries made in their laboratories. Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies."
Andrew von Eschenbach concluded: "One of the biggest barriers research and academic institutions face is the ability to get discoveries made in the lab into clinical testing. The new Exploratory IND guidance emphasises the flexibility available to researchers when conducting early clinical testing of these cutting-edge treatments.
"As we enter the era of personalised medicine, these exploratory approaches enable scientists to take full advantage of new technologies to target the development of more individualised therapies.
The announcement is part of the FDA's critical path initiative, first launched in March 2004, intended to cut the early attrition rate of new investigational drugs.
Related links:
FDA Center for Drug Development website
