Mixed reactions to updated federal rules meant to increase clinical trials transparency

On September 16, the U.S. Department of Health and Human Services (HHS) issued a final rule dictating require­ments for registering certain clinical trials and posting summary results on ClinicalTrials.gov. The NIH also issued a complementary policy for regis­tering and reporting summary results to Clinical­Trials.gov for all NIH-funded trials. Although the new rule from the HHS does not govern phase I drug trials or small feasibility studies of devices, it applies to most interventional studies of drug, biological and device products that are regulated by the FDA. Essential elements in the final rule include providing additional types of adverse events, as well as the obligation to provide partici­pants’ race and ethnicity, if collected, along with the full protocol. The final rule concerns how and when the information is collected in a clinical trial, without placing any limits on how trials are designed and carried out, or even what data must be collected.

Eisai launches Andover innovative Medicines Institute for drug discovery acceleration

With an eye on the increasingly key role human genetics can play in drug development, Eisai has cre­ated the Eisai Andover innovative Medicines (AiM) Institute, which will focus on using genet­ics to develop targeted medicines for dementia, oncology and autoimmune diseases. The 90-scientist research and drug develop­ment unit is located in Andover, Massachusetts.

To read the full articles for this issue of The CenterWatch Weekly, please click here for subscription information.