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Sponsors would like to see clearer recommendations for non-inferiority assessments, demonstrating bioequivalence and targets for statistical analysis, before the European Medicines Agency adopts an international guideline on large clinical trials that span multiple regions. Read More
The National Cancer Institute opened a drug formulary as part of a public-private partnership with six pharmaceutical companies, allowing researchers to test the drugs in clinical and preclinical studies — alone or in combination with different companies’ products. Read More
The FDA compiled 22 case studies of different drugs, vaccines and devices that demonstrated promising results in Phase II studies, but later failed in larger Phase III clinical trials. Read More
The FDA issued a draft guidance urging sponsors to work to control error rates before launching clinical trials with multiple endpoints, and provided several examples of appropriate statistical methods. Read More
HHS backed down from implementing its more controversial provisions in a broad overhaul of its Common Rule, including requiring researchers to obtain written consent before testing a donor’s biospecimens, even if the samples were presented with no personally identifying information. Read More
The International Council on Harmonisation announced several new international members, in a Feb. 2 report on its November meeting in Osaka, Japan. Read More
Several large drugmakers and industry groups commented on FDA’s proposal to require higher quality management standards for nonclinical studies used to support product applications. Read More
The FDA compiled 22 case studies of different drugs, vaccines and devices that demonstrated promising results in Phase II studies, but later failed in larger Phase III clinical trials. Read More
Fifteen FDA officials, including Commissioner Robert Califf, called for the broader uses of research methodologies in real-world settings, but cautioned against expectations for “quick wins” in efficiency and savings. Read More