Unsustainable And Burdensome: Today's Safety Reporting Fails Sites, Sponsors And Patients

By Steven Beales, Senior Vice President, Scientific and Regulatory, WCG, and Joe O'Rourke, Vice President, Business Development, WCG

The way most sponsors and CROs approach safety reporting overburdens sites. Sponsors bombard sites with safety notifications, many of them unnecessary. Sites are overwhelmed to the point they may miss the critical patient-safety information.

Safety reporting is one of the last areas of hidden cost and inefficiency in clinical trials today, costing sponsors millions or tens of millions of dollars each year in excessive site payments and monitoring costs on unnecessary or duplicate safety reporting. Few receive value for their investment, and some don’t even know how much that investment is.

The entire process is also prone to error and over-reporting, burying important new safety information and putting patients at risk. Moreover, one mistake can lead to regulatory repercussions, delays—even having a trial go into rescue or be shut down. Even if the trial remains unaffected, sites are disinclined to work again with sponsors who bombard them with superfluous, burdensome paperwork. Given the fierce competition for top-tier sites, no sponsor can risk alienating them.