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Sponsors registering new drugs or updating existing drugs on the Australian Register of Therapeutic Goods will need to conduct biopharmaceutic studies and generate specific data on test results, the Therapeutic Goods Administration says. 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
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Clinical research staff working on corrective and preventive action reports should think seriously about the root causes of good clinical practice violations identified at their sites and how to prevent those errors from recurring. 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
Clinical trial investigators in India must limit their work to no more than three trials at any given time, according to one of the mandates in 14 finalized regulations issued by the Central Drugs Standard Control Organization. Read More
The EU-based Innovative Medicines Initiative is launching a $4.5 billion decade-long effort to improve the success rate of clinical trials for certain drugs by 30 percent and boost exclusivity to entice sponsors to develop the drugs. 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
The goal of recruiting sufficient numbers of minority patients at U.S. clinical trial sites is hardly ever reached, rather than hard to reach, a trials expert says. Read More
The number of clinical trials in India is rebounding after plunging precipitously in the wake of strict government regulations imposed on the industry. Read More
Patient recruitment remains one of the biggest roadblocks to speedy clinical trials, but the problem could be eased with greater use of electronic health records, a panel of experts told lawmakers July 10. Read More
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More