Too much data from clinical trials is concealed or disappears, a situation that is threatening the integrity of evidence-based medicine and harming patients, according to a scathing series of articles published this week in the journal BMJ (formerly known as the British Medical Journal).
The articles confirm the concerns of many bioethicists and others that much of the evidence from human trials involving drugs, medical devices and other treatments is unreported — or reported 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,” write Dr. Richard Lehman, a primary-care specialist at the University of Oxford, and Elizabeth Loder, a Boston neurologist and BMJ editor, in an editorial that accompanied the series. “And 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. Moreover, researchers or others who deliberately conceal trial results have breached their ethical duty to trial participants.”
One of the BMJ articles found that more than half of drug trials funded between 2005 and 2008 by the National Institutes of Health had not been published in a scientific journal within 30 months of completion. In fact, one-third of the trials examined remained unpublished at three years.
“When the word ‘mandatory’ turns out to mandate so little, the need for stronger mechanisms of enforcement becomes very clear,” Lehman and Loder write.
Other papers published in this special BMJ issue point out how difficult it is for even the most dogged researchers to access data from many drug studies and how when previously unpublished data are finally retrieved and included in large meta-analyses, the results often differ from what was initially reported.
As a result, it’s “almost impossible,” note Lehman and Loder, for patients and doctors to assess the real risks and benefits of various drugs and treatments.
“Concealment of data should be regarded as a serious ethical breach that it is, and clinical researchers who fail to disclose data should be subject to disciplinary action by professional organizations,” Lehman and Loder conclude. “This may achieve quicker results than legislation in individual countries, although this is also desirable.”