Publishing Your Clinical Trial
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Publication of a clinical trial is the culmination of an enormous effort; one that deserves an accurate and transparent report. Although the trial protocol and statistical analysis plan serve as the framework for a clear presentation of the results, it is an arduous task to condense the thousands of design details, data points, and analyses into a concise manuscript. Appointing a publication committee to outline the manuscript, settling questions of authorship, and selecting a target journal assures timely publication of the final report. Guidelines, including the CONSORT Statement, assist in writing a report that is complete and provides maximum value to the medical community. After the initial publication, a thoughtful secondary analysis plan not only maximizes knowledge gained from trial data, it can also help mitigate bias when there are unexpected results. Developing a data sharing plan ensures that the trial data continues to be useful long after the primary and secondary analyses are completed.
KeywordsRandomized clinical trial Publication standards Research design standards Clinical practice guidelines
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