Improving Clinical Trials Could Speed Delivery of T1D Therapies

Being a solution creator is among the most important roles that JDRF plays in our mission to accelerate life-changing breakthroughs to cure, prevent and treat type 1 diabetes and its complications. One of the biggest roadblocks to speeding promising research through the pipeline is the costly, time-consuming clinical trial stage, which can be a deterrent to drug and device makers entering the T1D field. As JDRF Chief Scientific Officer Richard Insel, M.D., highlighted during a panel at the recent Rachmiel Levine-Arthur Riggs Diabetes Research Symposium, JDRF is leading the effort to bring together stakeholders to address this and other barriers that are slowing the delivery of new treatments.

“It’s critical that we have industry by our side as we move the research we’ve funded into clinical development and trials, because industry ultimately will bring new therapies to market,” said Dr. Insel, who moderated the panel. “The big message we’re hearing from industry is that the way we conduct clinical trials today takes far too long and costs far too much.”

The panel included representatives from pharmaceutical and biotech companies Sanofi, Novartis and Janssen who spoke to the audience about identifying shared aims that could help shorten the time and cost of getting new T1D therapies to market. Establishing specific biomarkers (biological indicators that can be used to stage a disease or evaluate a treatment’s effectiveness) that could be used to select the best T1D subjects for a particular clinical trial or pinpoint a drug candidate’s effects more quickly and precisely, and convincing regulatory agencies to accept additional therapeutic outcomes as a basis for approving new T1D therapies were among the top aims discussed.

“Right now, launching and completing a T1D clinical trial is quite time consuming” said Marjorie Zakaria, M.D., a translational medicine expert for Novartis. “Identifying early-response biomarkers would allow us to more quickly determine dose adjustments and whether we can accelerate the trial to the next phase.”

The good news, said Dr. Insel, is that, due in large part to JDRF partnership and advocacy efforts, we are seeing more companies investing in developing T1D therapies. “JDRF has gone from just a handful of industry partnerships a decade ago to a few dozen active ones today,” he noted. “We’ve seen Janssen step up and name T1D prediction and pre-symptomatic intervention a goal of their Disease Interception Accelerator, and Sanofi has joined us in funding four different research projects aimed at developing glucose responsive insulins.

“These industry partnerships are a necessary part of the ecosystem that involves regulators, payers, providers, academia, the T1D community and funding organizations that we’re endeavoring to create to beat T1D.”