Risk-Based monitoring - ENDED

Companies engaged in commercial clinical research have, since the introduction of formalized good clinical practices (GCP), adopted highly defensive practices around the monitoring of clinical trials.  These processes have played a very large role in the high costs associated with clinical trials, without delivering commensurate value.  Reasons are many, but surely include propagation of practices established during the years that trials relied on paper-based case report forms (CRFs), despite the fairly widespread adoption of electronic data capture (EDC) quite a few years ago.  The reasons also include fear based on misunderstanding of regulatory requirements.  All of this has resulted in the institutionalization of high cost, low value, manpower-intensive practices that do little to serve the interests of subject safety or quality data.  Pharmaceutical, biotech, and medical device industries experiencing unprecedented economic upheaval can no longer afford the luxury of engaging in practices that deliver little value at exorbitant cost. Rather than continuing to spend time, energy, and money focusing on minutiae, e.g., the ability of site personnel to properly transcribe observations from one medium to another, those engaged in clinical trial conduct must re-focus their energies on  the aspects of the clinical trial that matter most, such as protocol compliance, subject safety, data timeliness, and data integrity.  Through the use of more up-to-date methodologies and technologies, companies can effectively address these concerns while saving both time and money. This paper addresses the regulatory and business rationales for adopting more rational monitoring-related tools and processes that, if implemented thoughtfully, should deliver higher-quality trial data, faster, and at significantly lower cost.