Articles published in BMJ and PLoS Medicine call for greater transparency in clinical trials through increased sharing of information. The BMJ editorial accompanies a cluster of research papers that show, despite regulatory pressure, many clinical trials fail to report data in a timely manner.
“This is no academic matter, because missing data about harm in trials can harm patients, and incomplete data about benefit can lead to futile costs to health systems”, Richard Lehman, of University of Oxford, and Elizabeth Loder, of BMJ, wrote.
In 2007 the US Food and Drug Administration (FDA) Amendments Act made publication of summary results on ClinicalTrials.gov mandatory within one year. An analysis of ClinicalTrials.gov published by BMJ yesterday found 40 per cent of industry funded trials had reported results.
The BMJ editorial calls for stronger enforcement to encourage data reporting. “Concealment of data should be regarded as the serious ethical breach that it is, and clinical researchers who fail to disclose data should be subject to disciplinary action by professional organisations”, Lehman and Loder wrote.
A paper in PLoS Medicinetackles transparency earlier in the process by calling for all investigators’ patient recruitment targets to be published on ClinicalTrials.gov before a study begins.
The authors of the paper, who include a former GlaxoSmithKline employee and an advisor to the Spanish Medicines Agency, also want information on issues that could affect recruitment to be shared.
“We propose for a given site, that if the trial has more than one recruiting principal investigator, then information for all recruiting investigators should be provided”, the authors wrote. Access to this data could help sponsors “recruit investigators with a track record of fulfilling their commitments”.