Study: Registered trials are going unpublished
Nearly one-third of registered clinical trials go unpublished five years after completion, a BMJ-published study found.1
By law, certain clinical trials and research studies involving human subjects must be registered on ClinicalTrials.gov, and results published on the website and/or in scientific journals. There has been some controversy involving studies that remain unpublished, including a group of researchers calling for the release of lost or unpublished trial data.2
In order to estimate how many trial outcomes go unreported, a group of researchers from Cooper Medical School of Rowan University in Camden, NJ, and the University of North Carolina, Chapel Hill, looked at 585 registered trials with at least 500 participants that were concluded before January 2009. The earliest registration date was November 1999, and the median date April 2006. Of those 585 trials, 171 (29%) were not published by November 2012. Of the unpublished trials, 133 did not publish results on ClinicalTrials.gov, as is required by the Food and Drug Administration Amendments Act. Thirty-two percent of the unpublished studies were industry-funded, while 18% were funded through universities, government, or grants of some sort. Eleven percent of the examined trials received some sort of federal funding; 80% were industry trials.1
"The non-publication of trial data also violates an ethical obligation that investigators have towards study participants," the study authors write. "When trial data remain unpublished, the societal benefit that may have motivated someone to enroll in a study remains unrealized."
References
- Jones CW, et al. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013;347:f6104.
- Doshi P, Dickersin K, et al. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ 2013;346:f2865.
