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.
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。
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.
在臨床干預試驗中，運用隨機分配是對照試驗中控制偏倚和混雜的最佳工具。研究人員必須確保在試驗報告中包含讀者所需要的信息，以判斷結果的有效性及其意義。事實上，完整的試驗報告可讓臨床醫生改進他們的臨床實踐，以反映當前最佳證據，并改善患者臨床終點。制定 CONSORT 聲明可協助研究人員、作者、審稿人及編輯了解臨床試驗報告中所需的必要信息。CONSORT 聲明適用于任何干預措施，包括草藥產品。當前草藥干預措施的對照試驗未充分報告 CONSORT 建議的信息條目。我們希望最近制定的 CONSORT 建議條目擴展版能更準確地報告草藥干預措施隨機對照試驗，使其更加完整。我們編寫的這份解釋性文件除概述了每項建議的理由外，還提供了 CONSORT 條目和相關詳細說明，并為每項建議提供了良好報告和經驗證據的范例，以幫助作者能更好地運用它們。隨著越來越多的證據積累和反饋意見的收集，這些有關草藥產品臨床試驗報告的建議可隨時進行修訂。
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.