Statement on Registering Clinical Trials

Introduction

The Association for Research in Vision and Ophthalmology (ARVO) has required since July 1, 2006 that clinical trials with two or more groups of subjects be prospectively registered for publication in ARVO journals or as an Annual Meeting abstract. This requirement derived from the need to preclude “hidden trials” and promote ethical human research, and is consonant with policies of International Committee of Medical Journal Editors (ICMJE), several leading peer-reviewed ophthalmic journals, the Association of American Medical Colleges, the World Health Organization (WHO), and regulatory and government agencies.

Recently, several of these organizations expanded the requirement for clinical trial registration to include prospective studies with only one subject group. In July 2009, ARVO decided to update the ARVO clinical trials registration policy to require registration of all prospective interventional studies of human subjects, including those with only one subject group (i.e. phase 1 trials). This change was to be mandated on July 1, 2010.

While ARVO recognizes the importance of the WHO's definition of phase 1 trials and the benefits of providing information about preliminary trials to the public, there are controversial implications with regard to implementing the WHO recommendation. After extensive discussion by the ARVO Committee on Ethics and Regulation in Human Research, the Clinical Trials Registration working group and the ARVO Board of Trustees, ARVO has decided that it will not require studies with only one intervention group to be registered at this time. However, publication elsewhere may require such registration, and the conservative approach would be to register any study where there is an attempted therapeutic intervention in humans. ARVO will continue to monitor the implications of implementing the WHO guideline. An unintended consequence of the guideline might be the inability to publish worthwhile research because of honest misinterpretations of the new guideline by study investigators. We will notify investigators when reviewers believe a submitter's “one group” study meets the WHO requirement for registration, but we will not reject the submission until the implications of the change in requirements are fully understood.

Guidelines on Clinical Trials Registration

  1. Beginning July 1 2006, ARVO has only considered for publication articles or abstract submissions dealing with clinical trials of 2 or more groups of subjects that were registered before the first subject was enrolled. Trials of two or more groups of subjects that began before this date and were not registered must be registered. The beginning date of the trial, the date of registration, and the registration number must be provided at the time of manuscript or abstract submission.
  2. Investigators who submit manuscripts or abstracts involving prospective studies with only one study group will receive a notice from ARVO notifying the author that, in the opinion of the reviewers, this study would meet the WHO requirements for registration, and that although studies such as this will be currently allowed for publication by ARVO, the authors should consider registration of any similar studies in the future to assure that their results can be published.
  3. Clinical trials must be registered on an ICMJE- approved registry (www.icmje.org/faq.html) or a WHO Primary Registry (www.who.int/ictrp/network/primary/en/index.html). A WHO Partner Registry does not qualify.

    Registration must include completion of all 20 items on the list recommended by the WHO advisory group. The list of approved registration sites will be updated on either the Frequently Asked Questions or the Where Can I Register My Clinical Trial? page.
  4. The size of a clinical study is not a relevant consideration as to whether it must be registered. This policy applies not only to large, multi-institutional clinical trials sponsored by industry and other organizations, but also to individual investigators at a single institution who are conducting their own clinical research. The only consideration is whether the trial study is prospective and involves intervention in human subjects. For more information on what types of clinical trials should be registered, please visit the clinical trials registration FAQ.


Approved: ARVO Board of Trustees October 29, 2005
Revised and Approved: ARVO Board of Trustees, June 22, 2006
Revised and Approved: ARVO Board of Trustees, April 30, 2008
Revised and Approved: ARVO Board of Trustees, July 28, 2009
Revised and Approved: ARVO Board of Trustees, June 25, 2010

Contact us at clinicaltrials@arvo.org with additional questions.

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