|FDA: New Plan to Speed Drug Development|
|By Staff and Wire Reports|
|Thursday, 27 December 2012 12:15|
The FDA has issued guidance outlining how drug companies can select patients more likely to show a benefit from a studied drug and how companies can help improve the speed and efficiency of clinical trials.
In draft guidance published last week, the agency outlined specific examples of how drug developers can exclude poor potential candidates and select those more likely to show a clinical benefit.
For instance, if a drug company is studying a lipid-lowering drug meant to reduce heart attack risk, it may choose diabetic patients because they're more likely to have heart attacks and show an effect from the drug.
The FDA called these types of study designs "enrichment strategies" or "enriched studies."
"These are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs," Bob Temple, MD, deputy director for clinical science in the FDA's Center for Drug Evaluation and Research, wrote in a blog post on the agency's website.
The 42-page guidance listed several examples of ways enriched studies have been used to approve drugs already. More From MedPage.