A study published in The BMJ today shows that unregistered and retrospectively registered trials still get published in journals, in violation of medical research ethics and stated journal policies.
Non-registration and retrospective registration open the door to evidence distortion because researchers can shift the goalposts of a trial after the results are in. For this reason, the Declaration of Helsinki, which spells out global ethical standards for research in human subjects, clearly states that registering a trial before the first participant is recruited is an ethical requirement. In theory, all respectable medical journals require prospective registration.
Laws and regulations in several countries also mandate the prospective registration of some or all clinical trials, but governments fail to effectively enforce these rules, so compliance is weak.
The study shows (yet again) that public money continues to be misspent on clinical trials that are unethical and open to evidence distortion, to the detriment of patients and taxpayers alike.
Out of the improperly registered trials reviewed, 82 had been funded by public money, 33 by nonprofit foundations, and 22 by academic bodies. In contrast, only 7 had been funded by industry.
The study also demonstrates (yet again) that self-regulation by the medical research community simply does not work. According to its authors,
“Many such trials originated from well-established research groups in the USA, England, Canada and other countries with a stronger tradition and more training in clinical research.”
The study examined 123 academic papers reporting trial results that The BMJ had rejected over a four year period due to lack of prospective registration in a WHO-approved trial registry. It was conducted by Elizabeth Loder, Stephen Loder, and Sophie Cook.