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.
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.
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.
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.
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.
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。
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.
背景 隨機對照試驗（randomized controlled trials，RCTs）常用于評估社會和心理干預措施的效果，這些結果亦常被用于制定決策。有關社會及心理干預措施試驗結果的準確、完整和透明的報告，對了解針對這些干預措施的臨床試驗設計、實施、結果及這些結果的應用至關重要。然而，關于社會和心理干預措施的 RCT 報告質量仍不理想。CONSORT（consolidated standards of reporting trials）聲明改善了生物醫學領域 RCT 的報告質量，同樣，行為和社會科學方面也需要類似的高質量報告規范。我們的目標是基于 RCT 報告規范 2010 年聲明（Consolidated Standards of Reporting Trials 2010 Statement，CONSORT 2010）的官方擴展版，制定適用于社會和心理干預措施（social and psychological interventions，SPI）的 RCT 報告規范（CONSORT-SPI 2018）。 方法 我們遵循最佳方案制定報告規范的擴展版。首先，我們對現有報告規范進行了系統評價。隨后，我們進行了有 384 位國際參與者參加的德爾菲在線調查。2014 年 3 月，我們舉行了為期 3 天的共識會議，由 31 位專家參與，確定針對社會和心理干預措施的 RCT 報告的檢查清單內容。專家們仔細討論了先前與社會和心理干預措施 RCT 相關的研究和方法學問題。然后，投票決定對 CONSORT 2010 條目的修改或擴展。 結果 CONSORT-SPI 2018 檢查清單擴展了 CONSORT 2010 的 25 個條目中的 9 個，包括：背景和目標、試驗設計、受試者、干預措施、統計方法、受試者流程、基線數據、結果和估計及資助來源。此外，與會者還添加了一個與利益相關方參與度有關的新條目，此外，也修改了與受試者招募和及其后續維持相關的流程圖。 結論 作者應使用 CONSORT-SPI 2018 來改善社會和心理干預相關的 RCT 的報告質量。期刊應修改編輯政策和程序，要求作者使用報告規范準備相關稿件，要求同行評議者使用報告規范評審相關稿件，以使讀者能夠評估研究的質量，評價研究結果的推廣性，并重復有效的干預措施。