Editors reiterate trial registration call
their call for the registration of drug trials before the first
patient is enrolled,in a medium that is fully searchable and
publicly accessible at no charge.
The statement follows on from comments made in September 2004, where members of the International Committee of Medical Journal Editors (ICMJE) published a joint editorial aimed at promoting registration of all clinical trials.
Under current European regulations, pharmaceutical companies are not generally required to disclose results of a trial or even whether one was conducted. The tendency by drug companies to focus on positive results has led to calls by academic researchers for a full registry of drug trials, which is open to all registrants and not for profit.
Members of the International Committee of Medical Journal Editors (ICMJE), said they will consider publishing results of clinical trials that begin enrollment on or after July 1, 2005. In addition, the journals will accept retrospective registration of trials that began enrollment before July 2005 as long as registration is complete by Sept. 13, 2005.
It stated: "We think the public deserves to know about trials that could shape the body of evidence about clinical effectiveness or adverse effects."
The ICMJE editorial warned against researchers leaving out key information when they registered a trial. Specifically, it said that researchers must name the treatment in a meaningful way so that patients and others know what intervention is under study.
Initial calls for the introduction of a registry comes after an ongoing investigation that claimed GlaxoSmithKline (GSK) suppressed negative results of trials that tested the safety and efficacy of Paxil (paroxetine), its leading antidepressant drug.
In the face of mounting pressure, GSK responded to the lawsuit by publishing results of trials on its website showing the drug is broadly ineffective in children and adolescents and could increase risks of suicidal behaviour. Glaxo had always denied the allegations, saying it has already publicised the results, either in medical journals or at scientific meetings.
The comments were made in a joint editorial: Is This Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors," which was released on the ICMJE's website.
Harold Sox, MD, editor of Annals of Internal Medicine, said: "Our first editorial was a wake-up call for researchers, trial authors and sponsors. This editorial reaffirms our intent and tells researchers what they must do to meet our requirements for editorial review and subsequent publication."
The editorial also advises authors not to "use meaningless phrases to describe key information."
The ICMJE are amongst a number of organisations that are calling for increased regulation of the clinical trial process. The World Health Organisation (WHO), have recently expressed the need for a worldwide information standard that trial authors must disclose.
Among the bodies considering new legislation is the US Congress, where the proposed Fair Access to Clinical Trials (FACT) Act would expand the current mandate for registration of clinical trials. In addition, many other journals have adopted our policy of requiring trial registration.
Christine Laine, senior deputy editor of Annals of Internal Medicine, said that the ICMJE has adopted the World Health Organization's minimal data set, or list of required items that each trial must include.
"WHO, which has also been working on trials registration, came up with a set of 20 required data elements remarkably like ours," said Laine. "We hope that by harmonising WHO and ICMJE policies, we can move toward a meaningful registration process that is truly global."
The case of GlaxoSmithKline highlighted an added motivation for the drug companies to join the proposed registry. Often drug companies use a publication of their drug in one of the respected journals to persuade doctors of its effectiveness and efficacy.
But it could be that drug companies who do not want to make their results public could still get the data published in less prominent medical journals, receiving lesser attention from the medical world.
