Year: 2015
Type: article
Abstract: In this week's PLOS Medicine, the World Health Organization (WHO) publishes a landmark position statement, requiring all trials to make their methods and results available [1].This represents important progress on a long-standing and global structural problem that has a clear, negative impact on patient care.The best currently available evidence shows that the methods and results of clinical trials are routinely withheld from doctors, researchers, and patients [2-5], undermining our best efforts at informed decision making.From this point forward, whenever the methods and results of a trial are withheld, doctors, patients, researchers, campaigners, and health care providers will be able to point at an unambiguous statement from WHO.Delivering definitive change, however, will require more than positive statements and good intentions.The first quantitative data demonstrating publication bias in clinical trials-and clear call for trial registries-was published in 1986 [6].Anyone withholding the methods and results of a clinical trial is already in breach of multiple codes and regulations, including the Declaration of Helsinki, various promises from industry and professional bodies, and, in many cases, the United States Food and Drug Administration (FDA) Amendment Act of 2007.Indeed, a recently published cohort study of trials in clinicaltrials.govfound that more than half had failed to post results; and even though the FDA is entitled to issue fines of $10,000 a day for transgressions, no such fines have ever been levied [3].In the face of such slow progress, this commentary sets out some practical suggestions for auditing, performance tables, accountability, codes of conduct, and better data that should help to drive up standards and prevent trial reports being withheld from those who need them most.
Source: PLoS Medicine
Author: Ben Goldacre
Language: English
Subfield: Issues, ethics and legal aspects
Field: Nursing
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $6,460
OpenAlex ID: W2105988708