Abstract
The importance of randomized clinical trials is acknowledged by most physicians, professional organizations, and federal agencies. Clinical trials influence practice and are at the pinnacle of the evidence pyramid, either alone or as part of meta-analyses. However, many threats to the validity and scientific integrity of clinical trials can occur in their design, implementation, analysis, and reporting. Examples include modifications in primary and secondary outcomes or analytic approaches after the trial begins or after initial examination of data; manipulation and falsification of data; incomplete reporting of all available trial outcomes and selective reporting of important serious adverse events; and failure to report the results of trials with negative or unfavorable results.
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