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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
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current policy. 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
Citing industry concerns, the FDA has reversed plans for a proposed voluntary presubmission process that would have allowed sponsors to get reviewer feedback before submitting an investigational device exemption application. Read More
Sponsors are being encouraged to participate in an FDA pilot program aimed at designing and validating regulatory tools for use in developing new technologies. Read More
Clinical sites facing an inspection at the request of the Committee for Medicinal Products for Human Use must sign a letter consenting to the audit and promising to provide all relevant documents, a European Medicines Agency guideline on GCP inspection procedures says. Read More