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The U.K.’s Information Commissioner’s Office published a draft guidance on obtaining informed consent, ahead of stricter European Union regulations on data protection that take effect in May 2018. Read More
An NIH center announced that all clinical trial sites participating in its grant program have agreed to use a single institutional review board for each multi-site study. Read More
Pharmaceutical companies and clinical research organizations are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. Read More
Last year’s 21st Century Cures Act directed federal agencies to pursue an international pediatric clinical trials network, and to engage with foreign regulators alongside attempts to align international guidance. Read More
Clinical research organizations and pharmaceutical companies are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. 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
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
Pharmaceutical companies and clinical research organizations are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. 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