TransCelerate Advances Risk-Based Monitoring

By Ed Miseta, Chief Editor, Clinical Leader

November 2013 marked several noteworthy events for TransCelerate BioPharma, the industry group attempting to bring drug sponsors together to collectively identify and address broad industry issues. The non-profit organization achieved milestones on several of its original projects, expanded its membership to 19 sponsors and launched its second year initiatives. Three new initiatives, Common Clinical Trial Protocol Templates, Special Populations Clinical Trial Networks, and an Investigator Registry will be added to the original five initiatives. The group also announced it will expand on two successful projects – Site Qualification and Training and the Comparator Network.

The Risk-Based Monitoring initiative has developed and shared an approach for risk-based monitoring of clinical trials.   The goal is to move towards industry implementation of RBM techniques which enhance patient safety and quality of clinical data. Craig Wozniak, Head Americas Clinical Operations at GlaxoSmithKline, has been involved with this effort since its inception.

“There is a lot of discussion currently about risk based monitoring with companies trying to move from philosophy to conduct,” says Wozniak. “We selected this as one of our projects because when you look conducting clinical trials, significant efforts go into managing quality and subject safety.   It makes a lot of sense for us to ensure we are using our resources in the best way possible. Risk Based Monitoring defines the areas for focus and direct activities where they will have the biggest impact.”