Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Workshop Report (1999) / Chapter Skim
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7Introduction THE TOPIC The development of a new drug is a challenging and time-consuming proess. If preclinical testing suggests that a promising compound might be well tolerated in humans, it is tested for safety and pharmacokinetics in healthy volunteers (Phase 1)
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS8 assess the safety and effectiveness of the experimental therapy, as well as how to ensure the quality and integrity of that information, while controlling costs and reducing the time consumed by the clinical trial process. From FDA's perspective, the key issue is ensuring that data submitted in support of an application are a valid representation of the clinical trial, especially as the data pertain to drug safety, pharmacokinetics, and efficacy.
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INTRODUCTION 9 FIGURE 1. The Food and Drug Administration (FDA)
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS10 OVERVIEW OF ISSUES Presented by Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research, Food and Drug Administration The goal of improving health through the use of new medicines and medical devices cannot be achieved without public confidence in the clinical trials process.
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INTRODUCTION 11 The FDA role includes oversight of the Institutional Review Boards for the protection of human subjects, and the Investigational New Drug process for trials that are being performed in the United States. Once a marketing application is filed, FDA will inspect some of the clinical sites and compare the data in the application with those from among the sites.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS12 A second issue concerned streamlining, which addressed whether the existing system is effective and efficient, and produces the highest-quality data for the lowest possible investment. If the answer was negative, the Roundtable members asked the speakers to identify how the system could be improved.
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