New Study Warns of Biased Reporting in Randomised Controlled Trials
A new study published in the Journal of Clinical Epidemiology (DOI: 10.1016/j.jclinepi.2021.04.020) has revealed a concerning trend in the reporting of adverse effects in Randomised Controlled Trials (RCTs). Researchers analysed 1,200 RCTs and found that many trials focus more on benefits than adverse effects of the drug being trialled, potentially misleading about safety and efficacy.
The study, led by researchers from the University of Oxford, found that less than half of the RCTs provided sufficient information to assess reported adverse effects. This lack of comprehensive reporting can misinform clinical and policy decisions. The issue is not new; major guidelines introduced in 2004 by the CONSORT group aimed to improve reporting of adverse effects in RCTs. However, despite these guidelines, there has been only a slight improvement in reporting adverse effects in RCTs over the last 17 years.
The CONSORT group, a collaborative effort of researchers, editors, and methodologists, aims to improve the quality of clinical trial reporting, particularly through the CONSORT statement and its extensions. Yet, the new study suggests that many trials still selectively report certain harms, potentially misleading about the safety and efficacy of the drugs being trialled.
The study highlights the need for improved reporting of adverse effects in RCTs to ensure accurate and balanced assessments of drug safety and efficacy. Researchers urge trialists, editors, and policymakers to adhere to the CONSORT guidelines and improve the quality of reporting in clinical trials.
