Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer
June 8, 2011 | Journal Article
More stringent evaluation of orphan drug trials is recommended to ensure safety and efficacy.
Clinical Trials
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Designing Comparative Effectiveness Research on Prescription Drugs
October 1, 2010 | Journal Article
As comparative effectiveness research becomes a more prominent feature of clinical medicine, investigators and policy-makers would do well to seek lessons from prior examples of this type of research.
The ADVANTAGE Seeding Trial
August 19, 2008 | Journal Article
Seeding trials are clinical studies conducted by pharmaceutical companies designed to seem as if they answer a scientific question, but primarily fulfill marketing objectives they have not been described in detail.
Should FDA Require Drug Manufacturers to Test Effects of New Drugs on Varying Populations?
January 4, 2011 | Human Capital Blog Post
RWJF Scholars in Health Policy Research National Program Director Alan B. Cohen, Sc.D., had a letter in the December 29, 2010 New York Times (Avastin: Judging the Risks vs. Benefits), noting that Food & Drug Administration (FDA) approval of new drug ...