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Trialregister.nl

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Compulsory registration of clinical trials
Will be a requirement before submission to the BMJ from July 2005
“The case for registering all clinical trials—first advanced a decade ago1—is now unanswerable.”2 Edi- The BMJ’s criteria for a suitable registry tors of the BMJ and the Lancet made this statement in 1999. Five years of industry resistance, government impotence, Free to access, searchable, and identifies trials with a uniquenumber and public confusion followed. Medical journals persisted with noble intentions and wise words but were themselves in part resistant, impotent, and confused about how to enforce registra- Registered entry includes details to identify the trial and tion. Some journals, including the BMJ, tried an amnesty for investigator and includes the status of the trial unpublished trials, with little success.3 The BMJ also considered The research question, methodology, intervention, funding, and asking for compulsory registration, but it seemed to us that trial registries were too diverse, disorganised, and easily disregardedto insist on registration before submission. Nor did we want fees National Institutes of Health trials emanating from low or for registering trials to be a barrier to researchers wanting to middle income countries was met with this response: “The sorts of trials you have described are not eligible for registration in The world has changed. Undisclosed trials and duplicate and selective publication sting government agencies, clinicians, The BMJ’s criteria for a suitable registry are listed in the box.
researchers, and journals ever more frequently and painfully.
As registries become more sophisticated we may have to revise Crucially, this form of misconduct, which Iain Chalmers these criteria. For example, because hundreds of registries exist identified in 1990, distorts the scientific record.4 By suppressing there is already a role for a database—a metaregister—that aggre- negative findings and exaggerating positive ones, by downplay- gates trial information in individual registries. Individual ing harms and talking up benefits, healthcare decisions are based registries should allow their contents to be aggregated. A way of on incomplete data and ultimately harm the patients.
recording or linking to the results of trials might become an A BMJ theme issue last year spelt out the myriad essential criterion, as might information on competing interests entanglements between doctors and the drug industry, arguing that a new relationship based on transparency and trust was Examples of registries that meet our proposed initial criteria needed to protect patients.5 This year’s speed of reform has put are the International Standard Randomised Controlled Trial the drug industry on the back foot. Most notably, Eliot Spitzer, Number (ISRCTN) registry, managed by Current Controlled New York’s attorney general, won a landmark legal case against Trials—a commercial company that also owns BioMed Central GlaxoSmithKline forcing disclosure of undisclosed trial data on paroxetine in adolescents, data that support a long campaign to clinicaltrials.gov, and the UK National Register of Cancer Trials (http://212.219.75.236/ukcccr). The ISRCTN registry is not This week, many of the world’s leading medical journals— publicly owned—public ownership is one of the criteria in the those belonging to the International Committee of Medical ICMJE statement—but its content is freely available to the public.
Journal Editors (ICMJE)—announced a tough stance on trial Registration of trials in the ISRCTN registry is free for trials that registration. Trials that begin enrolment of patients after 1 July are “sponsored, funded, and carried out in developing and tran- 2005 must register in a public trials registry at or before the sitional countries, in line with HINARI (Health InterNetwork onset of enrolment to be considered for publication in those Access to Research Initiative).” The registration fee for all other journals. Trials that began patient enrolment on or before 1 July trials is £80 ($144; €117). Our view is that although public own- 2005 must register before 13 September 2005 to be considered ership is valuable, free public access suffices as an essential for publication.7 This is a policy we support, and we will use the criterion—whether ownership is public or private—and that an same deadlines for consistency—albeit with a couple of international registry is preferable to one focusing on the research needs of one nation. This is not to undermine the Firstly, we believe it is wrong to be too prescriptive about the ICMJE journals, but we believe that these modified criteria are choice of registry because registries for trials are in an early stage of development. The ICMJE statement proposes a set of essential Will this move by journal editors work? On their own, criteria and says that it “does not advocate one particular journals can change little quickly, but with the public and registry,” although only one registry meets its criteria: www.clini- governments (particularly the United States) whipping up a caltrials.gov, a registry sponsored by the US National Library of storm around the drug industry—and the researchers who con- Medicine. This exclusive endorsement by the ICMJE journals is spire with industry to suppress findings that may harm patients perplexing because clinicaltrials.gov offers registration only to and profits—journals have just done the public a service. The real “federal agencies sponsoring the clinical research studies (both question is how will industry respond? Missing out on the chance interventional and observational trials), private sponsors that of publishing favourable findings in prestigious journals by not have submitted an Investigational New Drug Application (IND) complying with this policy is undesirable for industry but the to the Food and Drug Administration (FDA), such as battleground will shift to monitoring of trials and ensuring that pharmaceutical companies, and organizations representing IND results—good, bad, or indifferent—are reported.
sponsors.”8 These restrictive entry criteria will not be met by many trials worldwide. An inquiry from one of the BMJ’seditorial board members about registering non-drug, non- BMJ Online First bmj.com
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Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial reg- istration: a statement from the International Committee of Medical Journal Editors.
Horton R, Smith R. Time to register randomised trials. BMJ 1999;319:865-6.
Roberts I. An amnesty for unpublished trials. BMJ 1998;317:763-4.
Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8.
www.nlm.nih.gov/services/ctgetfaq.html (accessed 13 Sep 2004).
Abbasi K, Smith R. No more free lunches. BMJ 2003;326:1155-6.
Dyer O. GlaxoSmithKline to set up comprehensive online clinical trials register. BMJ2004;329:590-1.
BMJ Online First bmj.com

Source: http://www.trialregister.nl/trialreg/docs/bmj_support.pdf

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The hastings center - essay - pharma goes to the laundry: public relations and the business of medical education

6. See the discussion in S. Brownlee, “Doctors without Borders,”13. D. Healy, letter to Peter J. Pitts, Associate Commissioner for Ex- Washington Monthly, April 2004. ternal Relations at the Food and Drug Administration, February 19,7. See J.M. Drazen and G.D. Curfman, “Financial Associations ofAuthors,” NEJM 346 (2002): 1901-1902. 14. “Depressing Research,” Lancet 363 (2004

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