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Appropriate Clinical Trial Registration Is the Key to Transparent Reporting and Publication

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What is the purpose of trial registration and why is it so important to the integrity of research? Clinical trial registration serves the following purposes. First, by preregistering the trials, the primary outcome (why do the study) and method (how to do the study) get disclosed to the public. This makes certain biases unlikely to interfere with the interpretation of the results. Second, preregistration prevents conscious or unconscious manipulation of the results. This protects the integrity of the study. Lastly, the trial registration process encourages the delineation of all the necessary steps from protocol construction to publication. This enables researchers to formally construct and complete a clinical trial. Overall, it is extremely important, both for the conduct and reliability of the clinical trial, that registration is completed before patient enrollment begins.

In summary, since the advent of the ClinicalTrials.gov platform, the importance of trial registration has been recognized gradually but consistently throughout the globe. However, challenges remain, including the reluctance to participate on the part of pharmaceutical companies and a mindset among the individual researchers that registration is onerous and may result in the report of insignificant primary outcomes. However, we must not forget that the goal of all research is to maintain the integrity and reproducibility of the clinical trial. It is imperative for each and every one of us involved in research to recognize the role of clinical trial registration. Previously, when training young researchers, the emphasis was placed upon study design and how to write up a manuscript for smooth publication in a high-impact-factor journal. It is time to add clinical trial registration, and, thus, the importance of adhering to the prespecified trial design and outcomes, to the syllabus for future researchers to learn transparency, collaboration, and consistency in their research. The goal is the best research, and, ultimately, the best patient care.


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