Reporting Concerns

Drug safety has become a significant issue to many portions of society. High visibility issues like the Vioxx litigation have no doubt increased that salience among the general public. Moreover, with changing demographics, economic trends, and wider numbers of medical applications of prescription drugs, usage of these drugs will only increase, as will the accompanying issue of drug safety.

There is a noteworthy uneasiness among some U.S. clinical investigators about the reporting systems associated with serious adverse events (SAE) in clinical trials. Among the challenges of running clinical studies, SAE reporting received the highest mention in this random sample of over 1000 investigators, regardless of whether the investigator site was a dedicated research organization or not, or whether the investigator was highly experienced or not.

Investigator Dissatisfaction with Clinical Trial Activity

Clinical investigators may be more sensitive to the general issue of drug safety because others have given such attention. For example, the Institute of Medicine highlighted the difficulty of anticipating possible drug safety issues with marketed drugs based upon the relatively small number of patients taking part in clinical research studies.

Investigator unease with SAE reporting may open other questions for sponsors. For instance, clinical investigators who feel uncomfortable with drug safety reporting may become more reluctant to allow their patients to participate in trials.—TTC (For more information, please contact help@ttc-llc.com.)