Registering Diagnostic and Prognostic Trials of Tests: Is It the Right Thing to Do?

In 2004, the International Committee of Medical Journal Editors (ICMJE)10 issued guidelines requiring registration of all clinical trials that initiated recruitment after July 1, 2005. Clinical trials were to be registered in one of the primary registries in the WHO Registry Network (16 registries as of April 2014) or in ClinicalTrials.gov. Key information about each study, including eligibility criteria and primary outcome measures, are recorded in the registry before the trial starts recruiting participants. The impetus for this action was to improve the ethical standards in the conduct and reporting of research and to assist the biomedical publishing community in the production and distribution of accurate and unbiased articles. Although ICMJE has targeted only clinical trials, publication bias and selective reporting are recognized problems throughout the entire biomedical literature. Positive findings are more likely to be reported than negative ones. Some authors of studies with negative findings perform multiple comparisons and numerous subgroup analyses not defined in the study protocol, to generate positive results, while failing to report the negative observations. Reported outcomes and primary hypotheses differ from those defined in the study protocol. Authors and sponsors, rather than journal editors, appear to be primarily responsible for the reporting bias, a practice that distorts the practice of evidence-based medicine and diminishes the value of systematic reviews and metaanalyses. Selective and incomplete reporting and the failure to report negative findings lead to unnecessary duplication of efforts. Such practices corrupt the validity of literature-based estimates of the risk–benefit ratio of interventions and of the performance of medical tests and, ultimately, can erode public trust in the biomedical research community. On the basis of these considerations a movement has started that is gaining momentum toward expanding the registration of studies involving human study participants beyond clinical trials. In this Q&A, the issue …