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International guidance on pediatric drug development should include provisions for remote electronic consent, and should clarify the information provided to patients prior to their enrollment in clinical trials, according to the Association of Clinical Research Organizations. Read More
Pediatric clinical trials protocols should be designed with input from stakeholders, according to the Clinical Trials Transformation Initiative on antibacterial drugs. Read More
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The FDA issued a draft guidance urging sponsors to work to control error rates before launching clinical trials with multiple endpoints, and provided several examples of appropriate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