Hundreds of thousands of patients have been exposed to potential harm in clinical trials whose results have yet to be published since their completion nearly five years ago.
This amounts to “a failure to honour the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation,” says the team behind the finding.
In a paper published today in the British Medical Journal, Christopher Jones, a physician at Cooper Medical School of Rowan University in Camden, New Jersey, and his colleagues looked at 585 clinical trials registered on the US government’s ClinicalTrials.gov website and officially completed as of January 2009. For 171, or 29%, of those, the team found no existing peer-reviewed publication. Although some of these had reported their results on ClinicalTrials.gov, 133 trials had no results on this site or in published journal papers.
Many medical researchers fear that studies that do not prove a treatment is effective are more likely to remain unpublished, skewing the medical literature and harming patients by giving a false impression of treatments’ efficacy. There are also concerns that the pharmaceutical industry may be tempted to bury findings that do not support the use of its products. (In Jones’s study 150 of the unpublished trials were funded by industry, 11 by the US government and 20 by other sources.)
But there is a more fundament ethical problem stemming from researchers’ failure to publish their findings, the authors of the report write.
“The non-publication of trial data … violates an ethical obligation that investigators have towards study participants,” they say. “When trial data remain unpublished, the societal benefit that may have motivated someone to enrol in a study remains unrealized.”
They estimate the total number of patients involved in just the 171 trials they found were unpublished was 299,763.