Improving Clinical Trial Reporting with CONSORT 2025 Updates
An article published by the Journal of the American Medical Association highlights recent updates made to the CONSORT checklist and how they ensure the accuracy of trial reports.
Clinical trials are responsible for generating some of the most important evidence in evaluating the efficacy of healthcare interventions. It is crucial that results from these trials are reported in an accurate, timely, and transparent manner. However, the clinical research industry has had its fair share of challenges with maintaining this practice. As such, the CONSORT (Consolidated Standards of Reporting Trials) 2025 statement has been released to provide a minimum set of essential areas to address in reporting the results of randomized clinical trials. These new guidelines have been published simultaneously in JAMA, BMJ, The Lancet, Nature Medicine, and PLOS Medicine.1
An earlier article published in JAMA noted the World Health Organization (WHO) found that a significant proportion of trials never make their results public. This lack of reporting constitutes research waste, as nonpublic research results do not contribute to the advancement of science or improving clinical practice.2
The CONSORT statement, first published in 1996, was created to improve the practice of clinical trial reporting and provides a checklist for what must be included in a report. There have been updates to it over the years, but the industry is still experiencing shortcomings with reporting. The updated CONSORT 2025 statement now accounts for recent methodological advancements and front-line feedback, while seeking to address some of industry’s challenges with reporting.
“Randomized trials, when appropriately designed, conducted, analyzed, and reported, are generally considered the highest-quality evidence in evaluating health care interventions. Critical appraisal of the quality of randomized trials is possible only if their design, conduct, analysis, and results are thoroughly and accurately reported. To interpret a trial accurately, readers need complete and transparent information on its methods and findings,” the authors wrote. “However, extensive evidence displays that the completeness of reporting of randomized trials is inadequate and that incomplete reporting may be associated with biased estimates of intervention effects.”1
The authors conducted a review of literature to generate a list of potential changes to CONSORT. They also included recommendations from the lead authors of existing CONSORT extensions and other reporting guidelines to bolster their list. Following completion of the list, a three-round Delphi survey with 317 participants was used to assess it. The survey was discussed at a two-day, online meeting of 30 invited international experts, from which the authors made substantive changes to the CONSORT checklist.
Among the changes made by the authors to CONSORT were the addition of seven new checklist items, three revised items, the removal of one item, and the integration of several items from key CONSORT extensions. The authors also restructured the CONSORT checklist, with a new section on open science.
“Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions,” the authors wrote. “We will engage with the leaders of these extensions to implement a process for aligning them with the updated CONSORT 2025 statement.”1
Keeping in line with the reflection of recent methodological advancements, the very first item added to the checklist is on data sharing, which includes the reporting of where and how individual participant data was deidentified. There is also a revision which calls for the sharing of where the trial’s statistical analysis plan can be accessed along with the trial protocol. A more detailed list of changes to CONSORT can be found in the JAMA article here.
“CONSORT 2025 represents a living guideline that will continue to be periodically updated to reflect new evidence and emerging perspectives. Such an approach is important to ensure the guidance remains relevant to end users, including authors, patients and the public, journal editors, and peer reviewers,” the authors concluded.1
References
1. Hopewell S, Chan A, Collins GS, et al. CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials. JAMA. Published online April 14, 2025. doi:10.1001/jama.2025.4347
2. Bruckner T, Rodgers F, Styrmisdóttir L, Keestra S. Adoption of World Health Organization Best Practices in Clinical Trial Transparency Among European Medical Research Funder Policies. JAMA Netw Open. 2022;5(8):e2222378. doi:10.1001/jamanetworkopen.2022.22378
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May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
