The requirement of the International Committee of Medical Journal Editors (ICMJE) that clinical trials be prospectively registered, before commencement,1 is an important step, but of equal or greater importance would be better regulation of trial data and their handling before publication.
Typically, a pharmaceutical company or its hired agent, such as a contract research organization, maintains all of the data collected during a trial. The analysis of the data and its statistical evaluation are generally performed by the company's statisticians. Even principal investigators are not usually privy to this information.
I propose the creation of a third-party organization, independent of the clinical trial sponsor, to perform the vital role of keeper of the trial database, as well as the data analysis according to the primary and secondary trial outcomes specified at the outset. Too expensive, some might say. However, funds are already being paid by the sponsor to have these same tasks done by employees within the company or by a contract research organization. Others might argue that this requirement would represent undue hardship for a company that is making a huge investment to develop its product and hopefully take it to market. This hardship would be lessened if it was applied uniformly to all major clinical trials. If the ultimate objective is to improve the lives of our patients, then the fidelity of clinical trial information is of paramount importance.
A clinical trial registry only provides transparency in terms of the existence of a trial. Third-party handling of trial data and their analysis will ensure transparent evaluation and reporting of the results. We need to enter an era wherein a high-quality trial is evaluated independent of those with a direct financial interest in its outcome.
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