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Commentary

Clinical trial registration: a statement from the International Committee of Medical Journal Editors

Catherine De Angelis, Jeffrey M. Drazen, Frank A. Frizelle, Charlotte Haug, John Hoey, Richard Horton, Sheldon Kotzin, Christine Laine, Ana Marusic, A. John P.M. Overbeke, Torben V. Schroeder, Hal C. Sox and Martin B. Van Der Weyden
CMAJ September 14, 2004 171 (6) 606-607; DOI: https://doi.org/10.1503/cmaj.1041281
Catherine De Angelis
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Jeffrey M. Drazen
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Frank A. Frizelle
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Charlotte Haug
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John Hoey
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Richard Horton
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Sheldon Kotzin
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Christine Laine
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Ana Marusic
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A. John P.M. Overbeke
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Torben V. Schroeder
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Hal C. Sox
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Martin B. Van Der Weyden
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  • A complete clinical trial register is already a reality for the paediatric field
    Maurizio Bonati
    Posted on: 07 February 2005
  • Clinical trial registration
    L. John Hoffer
    Posted on: 19 October 2004
  • Quality Clinical Trials
    Vincent G Bain
    Posted on: 12 October 2004
  • Posted on: (7 February 2005)
    Page navigation anchor for A complete clinical trial register is already a reality for the paediatric field
    A complete clinical trial register is already a reality for the paediatric field
    • Maurizio Bonati, Mario Negri Pharmacological Research Institute, Via Eritrea 62, 20157 Milan, Italy

    Pandolfini C, Rossi V, Santoro E “Mario Negri” Pharmacological Research Institute, Milan, Italy

    Arnau de Bolós JM, Danés Carreras I, Fuentes Camps I, Castel Llobet JM Fundacio Institut Catala de Farmacologia, Barcelona, Spain

    Jacqz-Aigrain E, Zarrabian S Hôpital Robert Debré, Paris, France

    Choonara I, Sammons H, Steingo J Derbyshire Children’s Hospital, University of Nottingham, Derby, United...

    Show More

    Pandolfini C, Rossi V, Santoro E “Mario Negri” Pharmacological Research Institute, Milan, Italy

    Arnau de Bolós JM, Danés Carreras I, Fuentes Camps I, Castel Llobet JM Fundacio Institut Catala de Farmacologia, Barcelona, Spain

    Jacqz-Aigrain E, Zarrabian S Hôpital Robert Debré, Paris, France

    Choonara I, Sammons H, Steingo J Derbyshire Children’s Hospital, University of Nottingham, Derby, United Kingdom

    In the last few months, the issue of trial registration has become one of the recurrent topics in medical journals. Although the need to register clinical trials in a publicly accessible register has been considered for years (1-4) it has only recently become a major issue. After the much publicised ordeal on the withheld data on SSRIs in children, different groups, from the American Medical Association, to individual scientific organisations, to the International Committee of Medical Journal Editors (ICMJE),(5-8) acted to increase awareness of the need for trial registration and put pressure on pharmaceutical companies to register all trials.

    Although having one single, all-inclusive, worldwide register would be optimal, areas such as paediatrics need special attention. The well- known difficulties in carrying out studies in young patients, along with the limited economic returns to pharmaceutical companies for paediatric drugs, has led to a scarcity of paediatric studies and therefore of knowledge on drug safety and efficacy in children. The lack of scientifically evaluated medicines for children has been recognised as an area that requires correction.(9,10) Legislation has been introduced in the USA (11) and is planned in Europe to increase the number of clinical trials in children. In order to facilitate research in paediatric patients, promote more network-based studies, and identify areas where research is needed, an international register of planned and ongoing clinical trials on drugs in children has been established, the DEC-net register (www.dec-net.org).

    The aims of DEC-net are to serve as an international database of ongoing and planned clinical trials on drugs in children where researchers, health professionals, sponsoring agencies, and the public alike can search for information on trials specific to children. The register was activated in 2004 and is run by groups of researchers from four countries, Italy, France, Spain, and the United Kingdom.(12) The DEC- net register is a three-year feasibility study supported by the European Union under its Fifth Framework Programme. It fits the criteria listed in the ICMJE statement, is free of charge, allows for data correction and updating, and is designed for use by the general public as well as by health professionals. The DEC-net register is different from ClinicalTrials.gov in that it is the only paediatric, population oriented trial register and has been set up to receive trial information from networks consisting of ethical committees, national health agencies, universities, national/international medical societies, hospitals, general practitioners, industry, and spontaneous reporters from different countries. Furthermore, the register has been designed to collect the International Standard Randomised Controlled Trial Number (ISRCTN) as well as the new EudraCT identification number. In an effort to further join forces internationally, while not losing its focus on the paediatric area, the DEC-net register was set up to comply with the criteria listed in the meta-Register of Controlled Trials, an international register of registers run by Current Controlled Trials (http://controlled-trials.com/mrct), so that future collaboration could be possible.

    In Europe, the recent creation of the European Clinical Trials Database (EudraCT; http://eudract.emea.eu.int), designed to include all trials in the community, is not open to the public, but only to the competent authorities of the Member States, the European Medicines Agency and the European Commission. Therefore, although it is international, the fact that it is of very limited access will, unfortunately, keep it from being directly useful to most researchers, physicians, and the public.

    The ICMJE statement, signed by 13 editors from 11 different medical journals, requires, as a condition of consideration for publication, registration in a public trial registry that meets a set of specific criteria at or before the onset of patient enrolment. ClinicalTrials.gov is mentioned as the only existing register that meets a set list of requirements, mainly: it must be accessible to the public at no charge, open to all prospective registrants and managed by a non-profit organisation, backed by a system to ensure validity of the data, and electronically searchable. It must also include a defined set of trial data. Given the importance of trial registration, as demonstrated by recent events, a momentous initiative such as that of the ICMJE should place more emphasis on the international level.

    Concern about ClinicalTrials.gov has been expressed, especially by non-American researchers.(13) The BMJ, in fact, published an editorial in which they state that they support the ICMJE policy, which has the same basic goal as the one they, along with numerous other medical journals, sustained with their 1997 amnesty for unpublished trials initiative,(14) except for the endorsement of ClinicalTrials.gov, since it only offers registration to specific categories of sponsors and not to everyone. We agree with what is stated in the editorial. A register, in order to be at the basis of such an initiative, should have world-wide aims; it should be designed with the idea, and capacity, to include all possible trials from different countries.

    1. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8.

    2. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol 1986;4:1529-41.

    3. Bonati M. Is it time for a registry of clinical trials in pediatrics? J Pediatr 1990;116:667-8.

    4. Chalmers TC. Randomize the first patient. N Engl J Med 1977;296:107.

    5. American Medical Association. AMA recommends that DHHS establish a registry for all US clinical trials [press release]. June 15, 2004. Available at: http://www.ama-assn.org/ama/pub/article/1616-8651.html.

    6. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin s, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. CMAJ 2004; 171: 606-607.

    7. American Medical Association. AMA provides outline for developing national clinical trials registry [press release]. Sept 9, 2004. Available at: http://www.ama-assn.org/ama/pub/category/13949.html.

    8. Rennie D. Trial registration: a great idea switches from ignored to irresistible. JAMA 2004; 292:1359-62.

    9. Conroy S, Choonara I, Impicciatore P et al. Survey of unlicensed and off-label drug use in paediatric wards in European countries. Br Med J 2000;320:79-82.

    10. Choonara I. Clinical trials of medicines in children. Br Med J 2000;321:1093-94.

    11. Spielberg SP. Paediatric therapeutics in the USA and internationally: an unparalleled opportunity. Paed Perinatal Drug Ther 2000;4:71-4.

    12. Bonati M, Pandolfini C, Rossi V et al. Launch of a European paediatric clinical trials register. Paed Perinatal Drug Ther 2004;6:38- 39.

    13. Abbasi K. Compulsory registration of clinical trials. Br Med J 2004; 329:637-8.

    14. Roberts I. Pharmaceutical industry is invited to respond to amnesty for unreported trials. Br Med J 1997; 315:683.

    Conflict of Interest:

    None declared

    Show Less
    Competing Interests: None declared.
  • Posted on: (19 October 2004)
    Page navigation anchor for Clinical trial registration
    Clinical trial registration
    • L. John Hoffer

    TO THE EDITOR: It was announced in your September 14 issue that the CMAJ and 12 other journals, including MEDLINE, will henceforth only publish controlled trials that were registered at their inception. Two reasons were offered for this decision. The first is that the widespread practice of concealing the results of trials with unfavourable results distorts the evidence base. The second is that patients volunteering for...

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    TO THE EDITOR: It was announced in your September 14 issue that the CMAJ and 12 other journals, including MEDLINE, will henceforth only publish controlled trials that were registered at their inception. Two reasons were offered for this decision. The first is that the widespread practice of concealing the results of trials with unfavourable results distorts the evidence base. The second is that patients volunteering for clinical trials deserve to know that their contribution to improving human health will be available to inform health care decisions, and this knowledge ought to be accessible to everyone. It appears, then, that pharmaceutical companies have an ethical as well as a scientific responsibility to register their clinical trials.

    It seems to us that many patients do participate in clinical trials for altruistic reasons, and moreover, the consent form they sign usually appeals, either explicitly or implicitly, to this motivation. If pharmaceutical companies have an ethical responsibility to register the controlled clinical trials they seek patients to participate in, should institutional review boards not require registration of large controlled clinical trials as a condition of ethical acceptability? Have institutional review boards anywhere taken a position on this?

    L. John Hoffer, MD PhD Jack Mendelson MD Jewish General Hospital Montreal, Quebec, Canada The authors are associate chair and chair of the Research Ethics Committee of this hospital

    Conflict of Interest:

    None declared

    Show Less
    Competing Interests: None declared.
  • Posted on: (12 October 2004)
    Page navigation anchor for Quality Clinical Trials
    Quality Clinical Trials
    • Vincent G Bain

    Dear Dr. Hoey:

    I read with interest the article about clinical trial registration as reported by the International Committee of Medical Journal Editors (ICMJE) which proposes prospective registration of clinical trials prior to their commencement. That is an important step, but of equal or greater importance would be to better regulate the actual trial data and its handling prior to publication.

    Typica...

    Show More

    Dear Dr. Hoey:

    I read with interest the article about clinical trial registration as reported by the International Committee of Medical Journal Editors (ICMJE) which proposes prospective registration of clinical trials prior to their commencement. That is an important step, but of equal or greater importance would be to better regulate the actual trial data and its handling prior to publication.

    Typically, a pharmaceutical company or its hired agents, such as a Contract Research Organization, maintain all the data collected throughout the trial. The analysis of the trial and its statistical evaluation is generally performed by the company’s statisticians. Even principal investigators are not usually privy to this information.

    I would propose the development of a third party organization which would be independent of the clinical trial sponsor to perform the vital roles of keeper of the trial data base as well as its analysis according to the primary and secondary trial outcomes as specified at the outset of the trial. Too expensive? Funds are already being paid out by the sponsor to have these same tasks done by either employees within their company or Contract Research Organizations. One might argue that this would represent an undue hardship to a company that was putting out a huge investment in order to develop their product and hopefully take it to market. However, this hardship would be lessened if it was applied equally and uniformly to all major clinical trials. If the ultimate objective is to improve the lives of our patients, then the fidelity of clinical trial information is of paramount importance.

    A clinical trial registry only provides transparency in terms of the existence of a trial. Third party handling of trial data and its analysis will ensure transparent evaluation and reporting of the results. We need to enter an era whereby a high quality trial is evaluated independently of those with a direct financial interest in its outcome.

    Yours sincerely,

    Vince Bain, MD, FRCP(C) Director, Liver Unit University of Alberta

    Conflict of Interest:

    None declared

    Show Less
    Competing Interests: None declared.
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Canadian Medical Association Journal: 171 (6)
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14 Sep 2004
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Clinical trial registration: a statement from the International Committee of Medical Journal Editors
Catherine De Angelis, Jeffrey M. Drazen, Frank A. Frizelle, Charlotte Haug, John Hoey, Richard Horton, Sheldon Kotzin, Christine Laine, Ana Marusic, A. John P.M. Overbeke, Torben V. Schroeder, Hal C. Sox, Martin B. Van Der Weyden
CMAJ Sep 2004, 171 (6) 606-607; DOI: 10.1503/cmaj.1041281

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Clinical trial registration: a statement from the International Committee of Medical Journal Editors
Catherine De Angelis, Jeffrey M. Drazen, Frank A. Frizelle, Charlotte Haug, John Hoey, Richard Horton, Sheldon Kotzin, Christine Laine, Ana Marusic, A. John P.M. Overbeke, Torben V. Schroeder, Hal C. Sox, Martin B. Van Der Weyden
CMAJ Sep 2004, 171 (6) 606-607; DOI: 10.1503/cmaj.1041281
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