Journal Article

Clinical trial registration: a statement from the International Committee of Medical Journal Editors

Schroeder, Torben V, Frizelle, Frank A, Hoey, John, Overbeke, A John PM, Haug, Charlotte, Laine, Christine, Van Der Weyden, Martin B, De Angelis, Catherine, Horton, Richard, Marusic, Ana, Kotzin, Sheldon, Sox, Hal C, Drazen, Jeffrey M

2004

Overview

The case against selective reporting is particularly compelling for research that tests interventions that could enter mainstream clinical practice. Rather than a single trial, it is usually a body of evidence, consisting of many studies, that changes medical practice. When research sponsors or investigators conceal the presence of selected trials, these studies cannot influence the thinking of patients, clinicians, other researchers, and experts who write practice guidelines or decide on insurance-coverage policy. If all trials are registered in a public repository at their inception, every trial's existence is part of the public record and the many stakeholders in clinical research can explore the full range of clinical evidence. We are far from this ideal at present, since trial registration is largely voluntary, registry data sets and public access to them varies, and registries contain only a small proportion of trials. In this editorial, published simultaneously in all member journals, the International Committee of Medical Journal Editors (ICMJE) proposes comprehensive trials registration as a solution to the problem of selective awareness and announces that all eleven ICMJE member journals will adopt a trials-registration policy to promote this goal.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Clinical trials / Clinical Trials as Topic - standards / Editorial Policies / Periodicals as Topic - standards / Public access / Registration / Registries