Clinical Trials: Rethinking How We Ensure Quality
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Clinical Trials: Rethinking How We Ensure Quality Martin J. Landray, PhD, FRCP1, Cheryl Grandinetti, PharmD2, Judith M. Kramer, MD, MS3, Briggs W. Morrison, MD4, Leslie Ball, MD2, and Rachel E. Sherman, MD, MPH2 Keywords clinical trial, good clinical practice, monitoring, quality assurance
Introduction
A New Paradigm—Quality by Design Concern is widespread that clinical trials are becoming increas- for Clinical Trials ingly costly and burdensome to conduct.1 The challenge is to find efficient and practical means of ensuring that trials provide conclusive answers while safeguarding the well-being of the patients who take part in them. Monitoring—often via site visits, post hoc data checks, and site auditing—is used to assess compliance with the protocol to ensure the safety of patients and the reliability of results. For trials that enroll large numbers of patients in multiple sites and multiple countries, the logistical and financial implications of frequent monitoring visits are daunting and are prohibitive for trials based in community or other routine health care settings. Furthermore, auditing a trial after patients are enrolled and data have been collected may not be the most efficient or effective means to ensure optimal human subject protection and trial quality. Accordingly, many in the clinical trial enterprise have expressed concerns about whether the current model for monitoring trials is effective and should be sustained. Parallels have been drawn to similar issues confronted by the pharmaceutical manufacturing sector in ensuring product quality. In response to the challenges posed by increased numbers of domestic and foreign facilities and the greater diversity and complexity of drugs and manufacturing processes, the US Food and Drug Administration (FDA) launched a risk-based quality initiative, ‘‘Pharmaceutical Quality for the 21st Century,’’2 which relies on quality by design (QbD). This approach posits that manufacturers identify critical process control points that substantially affect product quality and institute prospective measures to monitor the product at those points.2,3 Detection of unacceptable variation allows corrections to be made that will re-establish product quality. This initiative gives oversight of critical parameters and product quality to drug manufacturers, while the FDA initially ascertains that critical process control points have been identified and will be monitored appropriately and subsequently conducts selective inspections.
A QbD model can be envisioned for clinical trials whereby those responsible for the overall conduct of a trial would identify the critical aspects that, if not performed correctly, would threaten the protection of patients or the integrity of results. Those critical indicators of trial quality would be assessed on an ongoing basis so that corrective actions can be made early. In this context, trial quality is defined as the avoidance of errors that matter to decision making, and monitoring is repositioned as a tool for evaluation and improvement.4
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