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An FDA draft guidance that would require informed consent documents to include detailed descriptions of treatment alternatives to experimental drugs would confuse patients so much that recruiting subjects for clinical trials will become nearly impossible, drugmakers argue. Read More
The FDA has again rejected Amarin’s appeal for the agency to reinstate a special protocol assessment (SPA) on a phase III study of its triglyceride drug Vascepa, a move that casts doubt on the drugmaker’s ability to expand its indication on the fish oil-based product. Read More
Indian regulators are reminding drug investigators seeking approval for clinical trials that they must submit information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product to existing options. Read More
Local and regional medicines authorities need to have mechanisms in place to ensure that clinical trial data quality is preserved in secondary studies, a Washington, D.C.-based think tank says. Read More
Regulatory challenges in interpreting data from multiregional clinical trials have prompted the International Conference on Harmonisation to prepare a guideline on trial planning and design according to a recent concept paper. Read More
Clinical trial staff should report serious or continuing noncompliance issues and unanticipated problems occurring at trial sites to HHS’ Office of Human Research Protections in no more than a month, says Kristina Borror, director of OHRP’s Division of Compliance Oversight. Read More
Investigators need to keep informed consent forms simple so that patients grasp the fine points of the study protocol, and avoid inserting technical language they may not understand, an expert says. Read More
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 Aug. 20. Read More
Testing an experimental Ebola drug during an outbreak such as the one currently going strong in West Africa poses a number of ethical issues, clinical trials experts say. Read More