Reporting the findings of clinical trials: a discussion paper

Abstract

Background When researchers embark on a clinical trial, they make a commitment to conduct trial and to report findings in accordance with basic ethical principles. This includes preserving accuracy of results and making both positive and negative results publicly (1) However, a significant proportion of health-care research remains unpublished and, even when it is published, some researchers do not make all of their results (2) Selective reporting, regardless of reason for it, leads to an incomplete and potentially biased view of a trial and its results. (3) The consequences of publication bias and selective reporting have gained attention of health-care consumers, media and politicians. All have recognized impact that undisclosed results can have on ability of patients, practitioners and policy-makers to make well-informed decisions about healthcare. Concern over underreporting of adverse events, in particular, has increased demand for more transparent processes for registering clinical trials and reporting their findings. In recent years, trial registration has become increasingly widely accepted and implemented. There are now well-established mechanisms to register trials, assign unique identifiers and make this information publicly WHO's International Clinical Trials Registry Platform Search Portal helps bring data from these registers together, making it much easier to search for existence of a trial (available at: http://www.who.int/trialsearch). The value of registration goes far beyond administrative benefits of having a complete collection of all trials. Trial registers may facilitate recruitment into clinical trials by raising awareness of their existence among potential participants and health-care practitioners. They may also lead to more ethical and successful research by avoiding unintentional duplication of research already under way elsewhere. From perspective of this paper, however, greatest benefit of trial registration is enhanced transparency; that is, making it clear which trials are being conducted so that people can anticipate their results. The next step to informed decision-making is to make findings of clinical trials available, since it is knowledge of findings, rather than of existence of a trial, that is likely to have greatest impact on people trying to choose between alternative interventions. The arrival and growth of electronic publishing and Internet as dissemination tools without page or length restrictions has greatly expanded ability of people to make findings available and accessible in full. The recognition of need for reliable evidence to improve health care and to facilitate synthesis of results of research into systematic reviews has fuelled demand for access to findings of all research, as have needs of numerous other stakeholders in clinical research. A proposed position The position proposed by members of WHO Registry Platform Working Group on Reporting of Findings of Clinical Trials is that the findings of all clinical trials must be made publicly available. This paper discusses principles underlying this position. Our goal is to contribute to ongoing debate and to foster collaboration that is necessary to ensure that findings of clinical trials do not remain hidden from people who need access to them. What is a finding? The language used to discuss reporting of clinical trials usually focuses on results--often taken to mean numerical results of an analysis for a specific outcome. For example, a summary estimate such as a relative risk. However, reader or user of research also needs background information that will allow them to correctly interpret results for specific outcomes. The type and amount of information required will depend on nature of audience and how it will use information received but will have four key elements: 1. …