MASTRU contributes to CONSORT and SPIRIT 2025 International guidelines for clinical trials

The South African Medical Research Council’s (SAMRC) Mental Health, Alcohol, Substance Use and Tobacco Research Unit (MAST-RU) is active in the conduct of clinical trials in vulnerable communities most affected by drugs and alcohol.

Clinical trials are essential for evaluating the safety and effectiveness of new medical and behavioural interventions including those aimed at helping people who use drugs and alcohol. MASTRU staff strive to apply and enhance robust methods to improve the validity, feasibility and efficiency of clinical trials conducted by their unit. “We are proud to have contributed to the revision and update of the 2025 CONSORT and SPIRIT Statements, the gold standard for reporting clinical trials” says Professor Jason Bantjes, Director of MASTRU.

First published in 1996 and now updated in 2025, CONSORT (Consolidated Standards of Reporting Trials) emphasises the importance of accurate and complete reporting of randomised clinical trials. CONSORT is supplemented by SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), which has also been updated.

Journal articles are the public records of many randomised clinical trials, and the CONSORT reporting guidelines describe the minimum information those articles should include. CONSORT has been widely cited and is among the top 1% of all research articles by article-level metrics, as tracked by Scopus and has been translated into 13 languages. It has received global endorsement by prominent editorial organisations, including the World Association of Medical Editors, the International Committee of Medical Journal Editors and the Council of Science Editors, as well as by the pharmaceutical industry.

The CONSORT and SPIRIT statements have been jointly published in the following journals.

• BMJ: https://doi.org/10.1136/bmj-2024-081477
• JAMA:  https://doi.org/10.1001/jama.2025.4486
• Lancet: https://doi.org/10.1016/S0140-6736(25)00770-6
• PLOS Med:  https://doi.org/10.1371/journal.pmed.1004589
• Nature Med:   https://doi.org/10.1038/s41591-025-03668-w

Read more about the CONSORT-SPIRIT guidelines | HERE

Read more about MASTRU | HERE