Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Workshop Report (1999) / Chapter Skim
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Pages 43-44
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43 Directions for the Future A major finding of the workshop was the need for collaborative systematic improvements. Related themes included the need for greater openness and communication; broader involvement of stakeholders, including consumer groups; greater efforts to build quality into the process; and careful attention to maintaining public confidence and the scientific integrity of the clinical trials and regulatory process.
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From page 44... ...
ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS44 to date plans for addressing the third proposed topic are still in their infancy, IOM has initiated communication with FDA and industry to begin making preparations to convene a symposium on consumer involvement issues, the second follow-up activity identified by the Roundtable members. A major goal of this symposium will be to demystify the drug development and drug safety process for consumers.
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