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PAPERBACK price:$34.75 add to cart Rights & Permissions Free PDF Access Sign in to download PDF book and chapters Free Resources PDF SUMMARY Display this book on your site! Related Titles The Future of Drug Safety: Promoting and Protecting the Health of the Public Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary Other Related Titles Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report (1999) Institute of Medicine (IOM) Citation Manager Export the bibliographic data for this book in your chosen format Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Citation Manager . "Summary of Issues." Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report. Washington, DC: The National Academies Press, 1999. Please select a format: Page 42   E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. Summary of Issues Janet Woodcock, M.D. The workshop was successful in broadening the dialogue between the Food and Drug Administration (FDA) and industry on the subject of data quality. This dialogue clarified many expectations on both sides, notably by dispelling the myth that FDA cannot accept errors in a submission. Major points stressed repeatedly throughout the workshop included recognition by FDA (1) that there will be errors in the clinical trial process, (2) that the existence of errors does not mean that there is fraud, and (3) that a reasonable number of minor errors is acceptable, as long as they do not compromise the reliability of the overall data set or the inferences that are being drawn from the data about the safety and effectiveness of the product. FDA reviewers described several instances in which they approved products despite sloppiness and even fraud at isolated sites, largely in part because the agency went to extraordinary lengths to reconstruct data sets and restore confidence in the reliability of the inferences drawn from those data. FDA deals with errors in almost every submission that it reviews. Foreign trials seem to have particularly high error rates. Although outright fraud is extremely rare, the violating investigators are likely to be conducting different trials for other sponsors. Although FDA feels that many of the errors they find would have been detected by adequate monitoring, several speakers questioned whether the entire system—industry in its monitoring and FDA in its reviews—is devoting too much attention to minor details when it should instead be looking for a better way to assess data quality or even a way to build data quality into the system. Page 42 Front Matter (R1-R12) Executive Summary (1-6) Introduction (7-12) Presubmission and Submission (13-25) FDA Regulatory Review (26-41) Summary of Issues (42-42) Directions for the Future (43-44) Final Comments (45-50) Appendix A: Workshop Agenda (51-55) Appendix B: Speakers and Panelists (56-58) Appendix C: Workshop Registrants (59-67) Appendix D: Glossary and Acronyms (68-76)

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Summary of Issues Janet Woodcock, M.D. The workshop was successful in broadening the dialogue between the Food and Drug Administration (FDA) and industry on the subject of data quality. This dialogue clarified many expectations on both sides, notably by dispelling the myth that FDA cannot accept errors in a submission. Major points stressed repeatedly throughout the workshop included recognition by FDA (1) that there will be errors in the clinical trial process, (2) that the existence of errors does not mean that there is fraud, and (3) that a reasonable number of minor errors is acceptable, as long as they do not compromise the reliability of the overall data set or the inferences that are being drawn from the data about the safety and effectiveness of the product. FDA reviewers described several instances in which they approved products despite sloppiness and even fraud at isolated sites, largely in part because the agency went to extraordinary lengths to reconstruct data sets and restore confidence in the reliability of the inferences drawn from those data. FDA deals with errors in almost every submission that it reviews. Foreign trials seem to have particularly high error rates. Although outright fraud is extremely rare, the violating investigators are likely to be conducting different trials for other sponsors. Although FDA feels that many of the errors they find would have been detected by adequate monitoring, several speakers questioned whether the entire system—industry in its monitoring and FDA in its reviews—is devoting too much attention to minor details when it should instead be looking for a better way to assess data quality or even a way to build data quality into the system.

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minor details