The Drug Information Association (DIA) announced an educational partnership with the Cardiac Safety Research Consortium (CSRC) called the Cardiac Safety Education Collaborative. The mission of the new collaborative is to improve the pharmaceutical, medical and academic communities’ understanding of cardiac safety, the leading cause of marketed drug recalls and drug development program terminations.
“Cardiac safety is a central component of drug development and everyone should know something about this field,” said J. Rick Turner, Ph.D., a CSRC executive committee member and chairman of its Partnership Liaison Committee. He is also a senior director of clinical communications at Quintiles, a Consortium member. “Not everyone needs to be an expert in cardiac safety, but we want to educate a broader spectrum of stakeholders, from academia, government and industry.”
Turner explained that the mission of the nine-year old nonprofit consortium—which includes 42 member companies and over 600 industry participants—is to advance the regulatory science of cardiac and cardiovascular assessments. CSRC supports research by encouraging stakeholders to share data and expertise. The Consortium’s research projects have included think tank incubator programs, studies of waveforms released from the FDA ECG warehouse and other areas of cardiac safety evaluation from preclinical through post-market periods.
“Through the new education collaborative, we want to make sure people understand that non-cardiac drugs are not supposed to have nasty heart effects,” Turner said. “But there is always a chance any new drug—no matter what the medical indication—will have bad side effects. What’s needed are dedicated clinical trials to examine potential cardiovascular adverse events such as a better examination of QT prolongation [a measure of the time between the start of the Q wave and the end of the T wave in the heart’s electrical cycle].”
“Having DIA as a partner enables medical concerns and research issues about cardiac safety to reach a wider audience,” said Susan Cantrell, DIA’s senior vice president and managing director of DIA Americas. Cantrell said that the DIA has worked with CSRC in the past on educational issues.
“The landscape is changing, which is why educating individuals and facilitating the work that each organization does is important for the DIA,” Cantrell said. “With this educational initiative, we and CRCS will be able to address unmet needs in the science of cardiac safety, bring key individuals together and publish the findings. DIA has done a significant amount of education but working with a research organization on an education collaborative is something new and important for us.”
Cantrell added DIA has collaborated with a number of organizations to advance its mission in providing forums to exchange vital information and discuss current issues related to health products, technologies and services. But cardiac safety is different.
“The one thing that stops drug development in its tracks is when cardiac safety issues arise,” said Cantrell. “So finding good ways of predicting them before they happen, and detecting them early, are crucial.”
Email comments to Ronald at firstname.lastname@example.org. Follow @RonRCW
This article was reprinted from Volume 19, Issue 24, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »