Plea to Establish a Registry of Clinical Trials on Cognitive-Behavioural Therapies and Cognitive Remediation

Dear Editor: In a 2009 article' published in The CJP reviewing treatment of obsessive-compulsive disorder, the authors noted that in the few available efficacy trials comparing medication and psychotherapy, cognitive-behavioural therapy (CBT) and (or) behavioural therapy has shown comparable or superior efficacy to medication. For a long time, psychopharmacological clinical trials, being mostly sponsored by the pharmaceutical industry, had been criticized for their lack of negative results concerning the medications being tested in these said trials. The scientific community has mobilized itself to solve this issue and over the last few years, it has become mandatory for psychopharmacological clinical trials to be listed in national and international registries, some of which are accessible online. 2^4 In Canada, there is no federal regulation that require researchers to register trials, though Health Canada is exploring that option: trial sponsors are encouraged to register trials in existing registers. Since 2004, the Canadian Institutes of Health Research (CIHR) has required that clinical trials it funds be registered in the United Kingdom Register. For instance, in 2008/09, 91 trials were obliged to register because of CIHR funding. Using these registries, researchers and clinicians can easily access all of the data concerning a molecule that has been studied in an observational or controlled trial. Further, these registries facilitate the elaboration of meta-analyses that must include negative, as well as positive, results to gain greater scientific meaning. Today, most of the internationally recognized scientific journals require a proof of subscription to one of these registries before accepting the results of a study for publication, which we believe is a self-evident and necessary change in an era of medicine that claims to be evidence-based. Recently, clinical trials involving approaches other than pure pharmacotherapy, such as CBT and cognitive remediation, have been carried out by our research group. A few of our studies produced negative end results; however, this allowed us to ascertain the difficulty in publishing such results as well as how their negative impact can influence our research team's desire to see them published.5 We believe the same thing happens in many other research teams and we worry that an important amount of information may be lost as negative results go unpublished and are not tallied up in any registry. We have recently consulted a large number of our colleagues studying CBT and cognitive remediation and realized that none of them ever felt an obligation to subscribe to any registry while carrying out large controlled studies involving these kinds of treatments. Thus this unavailability of negative results represents a significant inadequacy for these fields of research, as such results could definitely be useful to actual physicians and researchers. Moreover, advocates of registration are very satisfied with a recent aspect of the United States mandatory registration law (referred to as FDAAA 801). Clinical investigators must now submit basic results to a public database. This is the reason why we are now arguing on behalf of mandatory subscription to registries for all trials involving CBTs and cognitive remediation, as is already the case for psychopharmacological studies. Such registries would enable the scientific community to access negative results and conduct meta-analyses, as well as to structure and strengthen the knowledge we are developing in these fields of research. References 1 . Ravindran AV, da Silva TL, Ravindran LN, et al. Obsessive-compulsive spectrum disorders: a review of the evidence-based treatments. Can J Psychiatry. 2009;54(5):33 1-343. 2. US National Library of Medicine, US National Institutes of Health. Clinicaltrials.gov [Internet]. Bethesda (MD): US National Library of Medicine, US National Institutes of Health; 1997. …

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