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Promoting standardization of clinical trial data management in China

Data management system is a major factor affecting the quality of clinical trial. Development of data management system include a steering group and data safety and monitoring board, data collection, database, performance of the data safety and monitoring, as well as locking of database. This article provides key issues of the five parts so as to help researchers understand the clinical trial data management system.

Randomized Controlled Pragmatic Trial: Concept, Design, Practice

The two factors that affect enrollment of participants and the process of intervention in randomizedcontrolled pragmatic trials are similar to the situation of clinical practice, thus its effects are similar to the situation ofclinical practice. Therefore, when one estimates an intervention’s effect on a patient, it will be more similar to a real clinicalsituation than results taken from an explanatory trial. Due to the introduction of interventions and process variables usedin a pragmatic trial that conform to traditional Chinese medicine and acupuncture practices, more and more interest isgrowing among researchers in the traditional Chinese medicine field. This article introduces the principles and conceptsof the pragmatic trial, and the key points of design via some samples.

Changing face: from the publication of CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration to changing of clinical trials in China

Further improve the reporting quality of clinical research in China

Transparency and sharing individual participant data of clinical trials: a philosophical proposition about the medical study ethics and implications for clinical trials

Clinical trial transparency, include clinical trial registration, unbiased reporting results and sharing individual participant data (IPD), is one of the most important revolutionary concepts following clinical epidemiology and evidence-based medicine in the medical field. Sharing IPD is a medical ethics issue reflected a new sense of worth and constructing new rules of clinical trials. Our viewpoint is that from the essential purpose of clinical research, IPD is a social public property. Sharing IPD is a one of the best ways for respecting the contributions of the participants, and one of the keys for changing face of clinical trials.

Strengthen the process report of clinical trials, promote full transparency of clinical trials

The concept of clinical trial transparency has been promoted for more than 40 years. The act of clinical trial registration, report guidelines development, and data sharing has has been strongly pushed forward and become a common practice. The clinical trial process being the key procedure of trial operation and quality control, determines the accuracy of the results. However, the process report of clinical trials is insufficient. In this article, we summarize the importance of clinical trial process report and provide corresponding suggestions. We propose that medical journals, reporting guidelines developers and clinical trial registration platforms should work together to strengthen the process report of clinical trials and promote full transparency of clinical trials.

Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

若在已發表的報告中干預措施描述不完整，臨床工作者和患者就無法可靠地實施有效的干預措施，其他研究人員也無法在此研究基礎上重復或進一步開展研究。然而，已發表文章中干預措施的報告質量非常差。為提高報告的完整性并最終提高干預措施的可重復性，一個國際專家組和利益相關方共同制訂了描述干預措施的清單和報告規范（Template for Intervention Description and Replication，TIDieR）。制訂過程包括：相關清單和研究的文獻綜述，針對國際專家小組的德爾菲調查以指導選擇清單條目及召開面對面的小組會議。最終確定的 12 條 TIDieR 清單條目（包括：干預措施簡稱、實施理由、實施資料、實施過程、干預措施實施者、實施方法、實施地點、實施時間及強度、個性化方案、方案更改、預期效果和實際效果）是對 CONSORT（The Consolidated Standards of Reporting Trials）2010 聲明中條目 5 和 SPIRIT（Standard Protocol Items: Recommendations for Interventional Trials）2013 聲明中條目 11 的擴展。雖然該清單強調的是試驗中干預措施描述，但該指導仍適用于所有評價性研究設計。本文對 TIDieR 清單的每個條目進行了解釋和說明并呈現了高質量報告的實例。TIDieR 清單和報告規范可提高干預措施的報告質量，并且使得作者對干預措施的描述、審稿人和編輯對有關干預措施描述的評估、讀者對干預措施的使用更加容易。

Developing design, implementation and reporting guidelines for multi-center clinical trials is imperative

With the encouragement of national policy on drug and medical device innovation, multi-center clinical trials and multi-regional clinical trials are facing an unprecedented opportunity in China. Trials with a multi-center design are far more common at present than before. However, it should be recognized there still exists shortcomings in current multi-center trials. In this paper, we summarize the problems and challenges and provide corresponding resolutions with the aim to reduce heterogeneity between study centers and avoid excessive center effects in treatment. It is urgent to develop design, implementation and reporting guidelines to improve the overall quality of multi-center clinical trials.

CONSORT-SPI 2018 explanation and elaboration: guidance for reporting social and psychological intervention trials

背景 研發隨機對照試驗報告規范 CONSORT 聲明旨在幫助生物醫學研究人員透明地報告隨機對照試驗（randomised controlled trials，RCTs）。我們已針對社會和心理干預措施制定了 CONSORT 2010 聲明擴展版（CONSORT-SPI 2018），以幫助行為和社會科學家透明地報告這些研究。 方法 在對現有報告規范進行系統評價之后，我們進行了在線德爾菲流程（Delphi process）以優先考慮從系統評價中確定的 CONSORT-SPI 2018 清單的潛在條目。384 位國際參與者中有 321 位（84%）完成了 2 次調查。然后我們召開了由 31 位科學家、期刊編輯和研究資助者組成的共識會議（2014 年 3 月），最終確定 CONSORT-SPI 2018 檢查清單和流程圖的內容。 結果 CONSORT-SPI 2018 擴展了 CONSORT 2010 檢查清單中的 9 個條目（包括亞條目在內的 14 個條目），增加了一個與利益相關方參與試驗有關的新條目（包括 3 個亞條目），并修改了 CONSORT 2010 流程圖。本解釋與說明（E&E）文件是 CONSORT-SPI 2018 的用戶手冊，可幫助使用者更好地理解 CONSORT-SPI 2018。本文討論了每個清單條目的含義和原理，并提供了完整及明晰的報告示例。 結論 CONSORT-SPI 2018 擴展版、解釋與說明文件及 CONSORT 網站（www.consort-statement.org）是有助于改善社會和心理干預措施 RCTs 報告的有用資源。

Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement

草藥產品被廣泛使用，其成分及質量差異很大，在隨機對照試驗（randomized controlled trials，RCTs）中也十分常見。筆者基于 22 項 CONSORT 條目清單，對含草藥干預措施 RCTs 的報告內容提出推薦條目。經過電話溝通，筆者于加拿大多倫多與 16 位專家進行了專家共識會議。工作組通過了 9 項草藥 RCTs 的 CONSORT 清單條目，其中針對草藥干預措施的條目 4 闡述最為詳盡。這些推薦將會用于改善草藥干預措施 RCTs 的報告。