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Researchers looking to study the safety and effectiveness of medical devices should tailor their trials to the requirements of the specific technology, a report by the Dutch Royal Academy of Sciences concludes. Read More

Clinical trial sponsors are increasingly looking to optimized trial design methods to simplify their studies and increase efficiency, but obstacles still stand in the way, an expert says. Read More

Sponsors say an FDA plan to require informed consent documents to include detailed descriptions of treatment alternatives to experimental drugs could confuse patients such that recruiting clinical trial subjects will be nearly impossible, drugmakers argue. Read More

Sponsors submitting plans to test drug products in children in Europe need to provide the European Medicines Agency with information on all formulations being developed, according to final guidance published Sept. 27. Read More

Drugmakers seeking accelerated approval of a presurgical treatment for high-risk, early-stage breast cancer may consider conducting multiple trials rather than a traditional single trial, according to a new FDA guidance that aims to give sponsors an earlier indication as to the success of a drug candidate. Read More

Drug sponsors submitting plans to test products in children in Europe need to provide the European Medicines Agency with information on all formulations they are developing, according to a finalized pediatric investigation plan that took effect this week. Read More

A Florida clinical site was hit with an FDA warning letter after an investigator turned up multiple procedural violations. Read More

Montana clinical investigator John Wise received a warning letter for failing to maintain records of clinical trial protocols. 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