Clinical Trials Advisor

Drugmakers are paying anywhere from $3 billion to $5 billion annually for clinical trial procedures that may not be necessary, a new study concludes.

Drugmakers and regulators can be more confident about the rigor of trial data coming from emerging markets as the quality of studies appears to be on par with trials in more research savvy, developed nations, a new study concludes.

When recruiting clinical trial patients, research sites need to strike a delicate balance between crafting overly broad advertisements that don’t target a trial’s primary population and ads that are so narrow they will lead potential subjects to wrongly believe they aren’t qualified, an expert tells CTA.

PHILADELPHIA — Trial sponsors can minimize multiplicity concerns that arise from conducting studies with multiple endpoints by employing an “Occam’s razor-like philosophy,” an FDA official recommends.

Vaccine makers could see better clinical trial methods and pharmacovigilance approaches as the result of a proposed cooperative agreement between the FDA’s Center for Biologics Evaluation and Research (CBER) and the World Health Organization (WHO).

Trial sponsors should continue to include key documents with critical study information — such as protocol and statistical methods — in clinical study reports (CSR), even though those documents are now available in the trial master file (TMF), according to a question-and-answer document on the International Conference on Harmonisation’s (ICH) E3 guideline.

Clinical trial sponsors would be able to submit their study protocols and trial results to a single portal managed by the European Commission, under a proposed overhaul of the EU’s Clinical Trial Directive (CTD).

India’s drugs regulatory agency, largely nonfunctional over the last year, is causing some drug developers to pull back from conducting clinical trials in the country, John Lewis, the Association of Clinical Research Organizations (ACRO) vice president of public affairs, tells CTA.

Regulations on how clinical trial protocols are approved in Brazil may soon be amended to allow for swifter approvals if the protocols have already been approved by a country whose regulatory framework is recognized by Brazil, such as the FDA or European Medicines Agency.

The FDA slapped the IRB at a Kentucky hospital for a number of recordkeeping violations including not informing investigators and the research institution in writing of decisions to approve or not approve studies.

The EU Ombudsman criticized the European Medicines Agency’s (EMA) lack of transparency and guidelines for deciding when to require drugmakers to carry out pediatric clinical trials.