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France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Read More
The Secretary’s Advisory Committee on Human Research Protections is recommending the FDA revise its informed consent waivers for cluster randomized trials to mirror HHS rules. Read More
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements. Read More
The Secretary’s Advisory Committee on Human Research Protections is recommending revisions to the Common Rule that would provide further guidance on single IRB reviews. Read More
How much training do clinical investigators and clinical study staff need to stay up to date on good clinical practices, particularly to ensure compliance for multiregional clinical trials? In a recent study, the Clinical Trials Transformation Initiative evaluated the content, frequency, format and enrollment evidence of GCP training and provided recommendations to improve the efficiency of GCP training. Jonathan Seltzer, the director of clinical research at the Lankenau Heart Institute and a co-author of the study, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” talks with CTA about the findings.Read More
Sanofi and Regeneron Pharmaceuticals said their rheumatoid arthritis treatment sarilumab demonstrated superiority over AbbVie’s blockbuster Humira in a Phase 3 Study. Read More
The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators. Read More
The average cost of developing a new drug continues to rise, even as approval rates decline, according to a report that pegs the cost of ushering a candidate through FDA approval at $2.6 billion. Read More
The FDA’s plans to create a pilot database of clinical outcome assessments lacks the depth and breadth of data needed to make it worthwhile, according to comments from industry and advocacy groups. Read More