PACT to Accelerate Clinical Trials Statewide

Note: Support for the development of PACT is provided by UCSF's Clinical and Translational Science Institute (CTSI), which is funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) (Grant Number UL1 TR000004).

By Ron Leuty, San Francisco Business Times

A dozen California health centers and medical research institutions have signed on to a nascent program to create a sort of one-stop shop for drug developers to cut overhead costs and accelerate the pace of their clinical trials.

Five University of California campuses, including UC San Francisco and Davis, as well as Stanford University, Children's Hospital Oakland, Dignity Health and Sutter Health have signed on to the nonprofit Partnership to Accelerate Clinical Trials, or PACT.

The program originated through Dr. Clay Johnston, UCSF's associate vice chancellor of research, as a Bay Area-centric effort to help drug developers launch and manage multiple clinical trial sites. But it has caught fire statewide, attracting UCLA, UC Irvine and UC San Diego as well as Loma Linda University, Scripps Health and Sutter Health.

Traditionally, each clinical trial site requires a separate agreement with the drug developer and a separate institutional review board, or IRB, to approve, monitor and review biomedical research. The cumbersome, bureaucratic process can slow clinical trials by months, cost companies millions of dollars in study startup costs and ultimately delay drugs from getting to patients, said Una Ryan, chairwoman of the Bay Area BioEconomy Initiative.

PACT would manage a centralized IRB, assuring that each trial site's standards are met. By the third quarter of this year, it expects to start rolling out a tool to help identify potential patients for studies, and by the end of the year will offer coordinated budgeting and coverage analysis, according to a PACT fact sheet.

Read full story at San Francisco Business Times