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Clinical trials: what a waste

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g7089 (Published 10 December 2014) Cite this as: BMJ 2014;349:g7089

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Professor Ioannidis complains justifiably of trials that are unregistered, unfinished, unpublished, unreachable, or simply irrelevant. How does this deplorable situation come about, and how can it be remedied?

The first hurdle will be the State or Charitable research funding agency, who will vouch for the validity of the question being asked, and for the feasability of the Materials available and the proposed Method to answer it. Despite this ostensibly rigorous scrutiny, a number of studies disappeared into the sands of time because it was reasonably foreseeable that the requisite numbers of subjects would fail to materialise so that even the most compliant statistician would fail to spin gold from the limited data.

The next hurdle will be the research ethics committee that will examine the research protocol to determine its acceptability from its viewpoint. For a protocol to receive approval on ethical grounds, requires more than tinkering with the wording of information for subjects and for consent forms, it requires that scientific rigour be applied to the protocol. In practice, the research ethics committee’s reliance on the funder’s advisors opinion of the scientific merits of the proposed study, may be misplaced. (How bad studies can get accepted by committees of the elect, while good are rejected is another story.)

Research funders may request that the results of a study are published, and research ethics committees may make their approval conditional on publication, but it may be that they lack tenacity for enforcing it. Times are hard and research finances are constrained, but if research was required to be underwritten by the employing institution,and funds wasted on unfinished or unpublished studies were required to be reimbursed, this might concentrate the mind. But only if funding agencies and research ethics committees were so intended.

Competing interests: No competing interests

17 December 2014
Morris Greenberg
Retired
Extramural
London NW11 7SY