Integrity of Clinical Trial Data

Any clinical trial is only as good as the integrity and completeness of the data collected and published. Clinical Trial Monitors aim to verify that clinical data recorded is accurate, verifiable and complete. An article in the BMJ has called for disciplinary action on missing trial data.  It goes on to state that unpublished data from clinical trials, as well as inadequate reporting of data that are published, can undermine clinical decision-making, harm patients and waste public money invested in health systems. It calls for professional associations to take disciplinary action against clinical researchers who fail to disclose data.

Richard Lehman, senior research fellow in the Department of Primary Care at the University of Oxford, UK and Elizabeth Loder, the BMJ’s clinical epidemiology editor confirmed the fact that “a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately. We are not dealing here with trial design, hidden bias, or problems of data analysis—we are talking simply about the absence of the data”.