Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Workshop Report (1999) / Chapter Skim
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Pages 45-50
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45 Final Comments In 1997, 49 new therapeutic compounds for 39 diseases affecting an estimated 160 million people were introduced onto the market. Drug development is a lengthy and uncertain process, taking up to 15 years, with less than 1 in 10,000 compounds making it from preclinical testing to marketing.
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From page 46... ...
ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS46 • Standardize formats and procedures, where possible, to increase efficiency. • Simplify the experimental design because complex studies have the potential to yield more errors.
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From page 47... ...
FINAL COMMENTS 47 more forthcoming with FDA about its concerns and expectations. Conversely, FDA needs to reach internal consensus about its needs and expectations and then communicate that consensus externally.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS48 ished and if the data to be analyzed were prioritized in a hierarchy of importance and relevance over the long term. Additionally, the workshop outlined some of the challenges with regard to the quality and validity of data from clinical trials that lie ahead.
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From page 49... ...
FINAL COMMENTS 49 are the clinical investigators. The quality of data may therefore improve if medical monitors perform the site initiation visits.
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