A recent post from MedPage Today describes the newly published FDA draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” that will potentially improve the speed of drug development. The guidance outlines types of study designs, termed “enrichment strategies” or “enriched studies,” in which drug developers can select patients who are more likely to show a clinical benefit from a studied drug. Three types of enrichment strategies were highlighted in the guidance: strategies to decrease heterogeneity, prognostic enrichment strategies and predictive enrichment strategies. Employing these strategies can potentially result in reduced study size, faster drug development and consequently lower development costs. Several approved drugs, including cancer drug, trastuzumab (Herceptin) and cystic fibrosis drug, ivacaftor (Kalydeco) are identified as specific examples in the guidance of how “enriched strategies/studies” have been used to approve drugs. To read the FDA draft guidance, click here. To review the full article from MedPage Today, click here.
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