Consensus meeting for Developing the Reporting Checklists of Multicenter Clinical Trials

25 Oct 2023

栽種和平計劃啟動 / 浸大文學院長:要聆聽被壓迫者需求 栽種和平計劃啟動 / 浸大文學院長:要聆聽被壓迫者需求

Multicenter clinical trials play an indispensable role in assessing the efficacy of a new intervention or treatment, particularly in Phase II or III studies. Previous studies have shown that these studies often suffer from inadequate reporting of key details related to their design, implementation, and analysis, both in the protocol and final reports. This limitation reduces the practical and scientific value of the findings. Therefore, the Chinese EQUATOR launched a project aiming to develop guidelines to improve the reporting of multicenter trials, including two Extensions of the CONSORT 2010 and the SPIRIT 2013.

On 18 October 2023, the Chinese EQUATOR Centre hosted the consensus meeting of “Developing the Reporting Checklists of Multicenter Clinical Trials (MCT)” online via Zoom meeting. Thirteen experts from eight countries attended this consensus meeting, including professor An-wen Chan from University of Toronto, professor Anna-Bettina Haidich from Aristotle University of Thessaloniki, professor Hongcai Shang from Beijing University of Chinese Medicine, professor Ichiro ARAI from Nihon Pharmaceutical University, professor Monica Taljaard from Ottawa Hospital Research Institute, professor Myeong Soo Lee from Korea Institute of Oriental Medicine, professor Tammy Hoffman from Bond University, professor Xin Sun from Sichuan University, professor Yaolong Chen from Lanzhou University, associate professor Kwok Ming Ho from University of Western Australia, assistant professor Haiyong Chen from University of Hong Kong, assistant professor Lisa Susan Wieland from University of Maryland, and senior researcher Chung Wah Cheng from Hong Kong Baptist University.

Prof. Zhaoxiang Bian first welcomed the experts participating in this meeting, and then introduced the background and objectives of the project. Professor Tammy Hoffman, the Clinical Epidemiology from Bond University, was invited to be the meeting chairman. After that, Dr. Xuan Zhang presented and elaborated on the Delphi results of two extended checklists. Experts then started to actively engage in a focused discussion and anonymous vote on fifteen items that did not reach a consensus in the Delphi process, including three extended items to SPIRIT and twelve extended items to CONSORT for MCT. The Zoom voting function was utilized, which enabled experts to indicate their agreement, disagreement, or abstention from voting regarding the items. Items with more than 65% agreement were included. After voting on each item, the aggregated results were presented to all experts for confirmation. At last, all the experts and workgroup members took a photo together.

Finally, one item was included and fourteen items were excluded. Thirty-one extensions to SPIRIT and eleven extensions to CONSORT for MCT were included in the final checklists according to the review and confirmation of consensus experts. Prof. Zhaoxiang Bian, the director of Chinese EQUATOR Centre, said, “We don't want people to not use it because of its impracticability. Actually, it is really fruitful to discuss and get feedback from every expert who contributed to this work from all over the world.”