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.
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.
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.
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.
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。
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.
Evidence produced by clinical trial is the main basis for health care decision-making at all levels. In recent years, some problems been revealed in the national data audit of new drug clinical trials have sounded the alarm for the quality of clinical research in China. In addition to strengthening the implementation of clinical trial process management and supervision, we call attention to the coherence and consistency of trial design and implementation, including the promotion of clinical trial design in the agenda of improving the quality of the trials and putting forward reasonable suggestions. We hope that our work could make research ideas clear from the source of a clinical trial, with a view to avoid violating protocol behavior and provide standardized recommendations for improving the quality of clinical trials in China.
臨床試驗報告規范 CONSORT（Consolidated Standards of Reporting Trials，CONSORT）聲明旨在提高隨機對照試驗（randomized controlled trail，RCT）的報告質量，然而該聲明卻缺少專門關于患者報告結局（patient-reported outcomes，PROs）的指引，而這部分內容恰恰也是臨床試驗經常報告不足的內容。患者報告結局指標數據的缺失影響了臨床試驗結果的價值。本文報告了依據“提高醫療衛生研究的質量和透明度協作網”（EQUATOR Network）所提出的報告規范研發方法學框架制定的臨床試驗報告規范—CONSORT 患者報告結局擴展版（CONSORT PROs）。最終推薦 5 個 CONSORT 患者報告結局清單條目，用于以患者報告結局為主要或關鍵的次要結局指標的隨機對照試驗。這些推薦條目強烈要求：① 在摘要中需明確說明將患者報告結局作為主要或次要結局指標；② 提供針對患者報告結局指標及其相關適用范疇的假設（如是否使用了多維度患者報告結局指標的檢測工具）；③ 提供或引用患者報告結局測量工具效度和信度的證據；④ 明確說明處理缺失數據的統計學方法；⑤ 討論以患者報告結局指標為研究結果指標的特定局限性和結果對其他人群和臨床實踐的影響。本文還提供了相關條目的示例和附有患者報告結局的 CONSORT 流程圖。建議在報告以患者報告結局作為主要結局指標或關鍵的次要結局指標時，以 CONSORT 患者報告結局擴展版與原版的 CONSORT 報告規范相互參考進行報告。改進后的患者報告結局試驗數據將大大促進對隨機對照試驗結果的全面解釋，并較好指導患者的治療。