Federal Rules Mandate Better Reporting of Clinical Trials

Results for many clinical trials that would now never see the light of day will be made public, thanks to new federal guidelines. The rules, announced Friday, will strengthen rules in place since 2007 that mandate the reporting of clinical trials involving humans that investigate new therapies for cancer, diabetes and heart disease.

The regulation states: “This final rule clarifies which clinical trials of FDA-regulated drug products (including biological products) and device products and which pediatric postmarket surveillances of a device product, are applicable clinical trials for which information must be submitted to ClinicalTrials.gov. The final rule considers all interventional clinical trials with one or more arms and with one or more pre-specified outcome measures to be controlled clinical trials.”