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Sponsors of device clinical trials should carefully examine the demographic distribution of study participants at various points during the study, the FDA says in final guidance published Wednesday. Read More
Implantable heart devices improve the chances of survival across racial groups, a study published in Tuesday’s Journal of the American College of Cardiologists concludes. Read More
The FDA has released a three-point action plan aimed at encouraging more diverse patient participation in medical device and drug clinical trials. Read More
Manufacturers of home-use devices should conduct usability tests early in design development and at later stages as the product evolves to ensure that user interaction problems caused by human factors have been addressed, the FDA says in final guidance released Tuesday. Read More
Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22. Read More
Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data? Read More
Evaluations of diagnostic test accuracy studies should include separate meta-analysis of positive and negative likelihood ratios, according to a draft guideline by the EU Network for Health Technology Assessment. Read More