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Trials of therapies targeting complicated intra-abdominal infections should limit active comparators to drugs that are standard of care, the FDA says, and minimize the use of outside antibiotics as much as possible to produce clear, definitive trial results. Read More
The FDA wants to expand the use of biomarkers to speed up drug development and is asking for feedback on ones that have the most promise of benefiting drugmakers in the near term. Read More
A German regulator says European Medicines Agency plans for implementing its clinical trials database let drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercially confidential information. Read More
Sponsors of clinical trials that rely on data from x-ray and other images should send those images to a centralized reading facility to prevent accidental unblinding or bias that may occur at trial sites, the FDA says. Read More
Drugmakers designing trials for alcoholism treatments can use a primary endpoint of no heavy drinking rather than total abstinence, the FDA says, in an acknowledgement that abstinence as a goal in these studies is often unattainable. Read More
Clinical trial sites using software to obtain patients’ informed consent remotely should make sure the data is stored securely, the FDA says. Read More
Sponsors and investigators will share responsibilities for gathering and reporting clinical trial information on clinicaltrials.gov, if a November proposed rule is finalized. Read More
The FDA warned a Phoenix, Ariz., clinical investigator for confusing audiometry reports for patients taking part in a clinical study of Purdue Pharma’s hydrocodone bitartrate painkiller. Read More
A new, first-of-its-kind clinical trial quality system created by CRO Analytics could help sites and sponsors track enrollment months earlier than conventional methods, experts say. Read More
The Institute of Medicine is calling on clinical trial sponsors and governments to develop plans for substantially greater sharing of clinical trial data. Read More