News Release

It's high time we registered all clinical trials say editors of Lancet and BMJ

Peer-Reviewed Publication

BMJ

Time to register randomised trials

The public has a right to know what medical research is being funded, argue the editors of the Lancet and the BMJ in a joint editorial published in this week's issues. What's more, researchers and their financial backers don't want to waste resources running trials that are already being conducted elsewhere, write the authors. They claim that the solution is to make sure that all clinical trials that are underway are registered for all to see.

Dr Richard Horton, editor of the Lancet and Dr Richard Smith, editor of the BMJ write that each year a vast financial investment is made by national funding agencies, medical research charities, and drug and device manufacturers in randomised controlled trials. The problem is, they say, that the process of undertaking research is "chaotic" and "..takes little account of concurrent research".

Another area of concern, say the authors, is that researchers conducting 'systematic reviews' (a systematic review is an overview of all the original research conducted into a certain subject area) need to know about ALL the trials that have been conducted on a subject to avoid 'publication bias' (where only the positive results of trials have been recorded). By ensuring that all trials are recorded, this problem could be overcome, they say.

The difficulty in undertaking to register all clinical trials is "who will take the lead?" say Horton and Smith. There are registration initiatives already underway (such as the NHS National Research Register and the Cochrane controlled trials register) but there are others within the medical research world who have roles to play, such as editors of journals and publishers.

The most significant recent lead has been taken by the pharmaceutical industry say the authors and they note that GlaxoWellcome and Schering Health Care have committed themselves to registering clinical trials, making a commitment to "..a climate of openness". According to Horton and Smith, such initiatives have led to critisism that the companies are opening up a "..window of vulnerability…in (their) commercial armour." How can this be, ask the authors, when all they are doing is releasing administrative information and not actual data?

Horton and Smith conclude that the pressure to register trials will only come when research ethics committees, medical research charities and drug and device manufacturers start to encourage trialists to register. Only then will the structure exist to "help to deliver high quality evidence to the clinical setting."

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Contact:

Dr Richard Horton, Editor, The Lancet

Or

Dr Richard Smith, Editor, BMJ c/o Jill Shepherd, BMJ Press Office


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