Requirement for registration of clinical trials

Abstract

In 2004, the International Committee o f Medical Journal Editors (ICMJE) recommended that clinical trials be registered in a public database as a prerequisite for subsequent publication.1De Angelis C. Drazen J.M. Frizelle F.A. et al.Clinical trial registration: a statement from the International Committee of Medical Journal Editors.N Engl J Med. 2004; 351: 1250-1251Crossref PubMed Scopus (672) Google Scholar The primary rationale for this recommendation was to assure the honest reporting of all clinical trials, including those with results that might “reflect unfavorably on a research sponsor’s product.”1De Angelis C. Drazen J.M. Frizelle F.A. et al.Clinical trial registration: a statement from the International Committee of Medical Journal Editors.N Engl J Med. 2004; 351: 1250-1251Crossref PubMed Scopus (672) Google Scholar In addition, a prospective registry of clinical trials would inform the scientific community, facilitate collaboration, and avoid duplication. Member journals of the ICMJE initiated this pre-registration requirement in July, 2005 for clinical trials “that prospectively assign human subjects to intervention or comparison groups to study the cause and effect relationship between a medical intervention and a health outcome.”1De Angelis C. Drazen J.M. Frizelle F.A. et al.Clinical trial registration: a statement from the International Committee of Medical Journal Editors.N Engl J Med. 2004; 351: 1250-1251Crossref PubMed Scopus (672) Google Scholar In 2005, the ICMJE clarified that “a trial must have at least one concurrent control or comparison group in order to trigger the requirement for registration.”2De Angelis C.D. Drazen J.M. Frizelle F.A. et al.Is this clinical trial fully registered?—A statement from the International Committee of Medical Journal Editors.N Engl J Med. 2005; 352: 2436-2438Crossref PubMed Scopus (189) Google Scholar Since public registration requirements were established by the ICJME the principle site of registration for this purpose has been sponsored by the National Library of Medicine (NLM) at www.clinicaltrials.gov. This site provides public access and registration at no charge and contains the minimal data required, including a unique identifying number and a statement of hypothesis, study design, outcome measures, eligibility, study dates, sponsor, and contact information. The 20 required data elements for trial registration recommended by the World Health Organization have recently been described in detail and are included on the NLM site.2De Angelis C.D. Drazen J.M. Frizelle F.A. et al.Is this clinical trial fully registered?—A statement from the International Committee of Medical Journal Editors.N Engl J Med. 2005; 352: 2436-2438Crossref PubMed Scopus (189) Google Scholar Detailed directions and a tutorial for registering a trial are available at http://prsinfo.clinicaltrials.gov. Effective July 1, 2007 the Journal of Vascular Surgery will adopt the policies recommended by the ICMJE and require the pre-registration of prospective clinical trials that have a control group. In addition, the Journal will also require the pre-registration of any commercially sponsored clinical trial, including Phase I and II trials. We believe this is important because many preliminary clinical trials test new drugs or devices and require the same altruistic patient volunteerism as Phase III trials. They deserve to be publicly registered. We do not anticipate registration of retrospective reviews or summaries of standard clinical treatment, although registration of any trial that is approved by a human studies review board is permitted at www.clinicaltrials.gov. Clinical trials that meet the above requirement and commence after July 1, 2007 must be registered prior to enrollment of the first patient. Relevant trials that began before this date must be registered prior to editorial review. Registration must be indicated by providing the unique study number assigned at www.clinicaltrials.gov. Further, data fields must be appropriately completed in this registry to provide sufficient information to clearly understand the intent of the trial. Authors of unregistered trials or those with inadequate information in the registry will be given an opportunity convince the Editors that their rationale for omitting this was critical, but it is our expectation that clinical trials involving prospective comparison of treatment or any that are commercially sponsored will all be registered after July 1, 2007.