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Regulatory Focus™ > News Articles > Temple: FDA in Process of Writing Guidance on Boosting Clinical Effectiveness

Temple: FDA in Process of Writing Guidance on Boosting Clinical Effectiveness

Posted 22 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's Deputy Director for Clinical Science, Bob Temple, often referred to as the agency's "dean of drug development," has announced the development of a new guidance on finding study populations in which a drug can be properly evaluated.

Writing on the Center for Drug Evaluation and Research's (CDER) website on 21 June, Temple described "enrichment design studies"-attempts to boost the clarity of a clinical trial's data by selecting a patient population that promotes a reduction in needless variability, clearly responds to the drug and clearly benefits from the drug.

Temple said enrichment "won't save a drug that doesn't work, but it will help find one that does."

For Temple, the need for guidance on enrichment design studies comes from advances in science allowing investigators to better assess the characteristics of patients before enrolling them into a clinical trial. "What has changed in recent years is a growing ability to find individualizing characteristics of patients, like genetic characteristics, that can permit these kinds of enrichment," wrote Temple.

"An issue to consider in any enrichment design is how much you need to study the people who don't seem to have the enrichment characteristic," continued Temple. "This is something to be worked out over time. But identifying a population that is more likely to show an effect is a wonderful first step."

"Predictive enrichment comes closest to what people hope for when they refer to individualization of therapy," concluded Temple. "Enrichment design studies help you reach this kind of individualization."

Temple had no information regarding when the guidance would be released to industry via the Federal Register.

Read more:

FDA - From a Clinical Perspective: Enrichment Design Studies Should Enhance Signals of Effectiveness

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