Clinical Trials Registration

Abstract

Over the past eight years, the registration of clinical trials has been strongly advocated by journals and editors, and is now considered to be mandatory for publication by most medical journals. In the United States, it became legally mandated by the Food and Drug Administration in 2007 (1), although Canada has no law requiring registration. Registration of a clinical trial ensures that the public has access to information regarding trials involving human subjects and health outcomes. Published clinical trials strongly affect decision making in health care, including decisions made at the bedside, in the boardroom and in the legislature. Therefore, the public needs to have access to the same evidence as the decision makers. Moreover, registering clinical trials and their protocols before data collection begins helps correct the distortion created by selective reporting in the literature (ie, ‘positive publication bias’), in which only trials with positive outcomes are published. Many also believe that the research community, by using human subjects, has a moral obligation to the public to publish their findings and a registry can reveal a disconnect in communication. In addition, registries can help standardize and improve clinical trial protocols, reduce overlapping or redundant publication and scientific misconduct, and improve accuracy in reporting. Several registries exist today, with the largest at administered by the US National Institutes of Health. Individual countries often have their own registry, many of which use the WHO’s International Clinical Trial Registry Platform guidelines. The International Committee of Medical Journal Editors has established six guidelines for the establishment of registries (2); although not all registries adhere to these guidelines, they provide insight to registry characteristics and expectations: Accessible to the public at no charge. Open to all prospective registrants. Managed by a not-for-profit organization. A mechanism to ensure the validity of the registration data must be available. Electronically searchable. Trial registration with missing fields or fields that contain uninformative terminology is inadequate. The International Committee of Medical Journal Editors defines a clinical trial as “any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome” (2). Health outcomes are further defined as “any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events” (3). In the current issue of the Canadian Journal of Respiratory Therapy, the study by Matthews and Fortier (4) (pages 11–14) – ‘The Rematee Bumper Belt positional therapy device for snoring and obstructive sleep apnea: Positional effectiveness in healthy subjects’ – has not been registered as a clinical trial despite the use of human subjects. Why? First, although the editorial board of the Journal strongly support registration of clinical trials, we do not believe that the study’s dependent variable – sleeping position – reached the definition of a health outcome. In addition, we believed that because the main reason for registration is to ensure the publication of important findings and the authors had submitted the manuscript for publication, this became a moot criterion. Although the Journal strongly believes in the value of clinical trials registration, we believed that, on balance, the rejection of an article reporting on a completed study solely on the basis of the absence of clinical trial registration was not in the best interests of patients nor health care providers. In making this decision, we consulted with experts in medical publishing and in clinical trials registration, and believe this to have been the most appropriate decision. As the Journal progresses in reputation and quality, we anticipate more submissions of clinical trial manuscripts and have been prompted by this particular article to codify a policy for clinical trial publication criteria that will be communicated in 2014. Going forward, we strongly encourage all authors and investigators to prospectively register their clinical trials in advance of conducting data collection. It is our intention to include these details in the publication of clinical trials manuscripts to enhance the transparency and quality of respiratory therapy research.