Reporting Concerns
Applied Clinical Trials
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.
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.)
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
