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.
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.
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.
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.
Using Chinese Materia Medica (CM) as injections is an innovation that is proving effective in extensive clinical use in Mainland China. However, recent reports have focused on adverse reactions, ignoring the considerable successes of these preparations. In order to achieve balance in the media and in the minds of the public, we suggest the first step is to clarify the concepts of and differences between adverse drug reactions (ADR) and adverse events (AE) for all concerned—the public, medical practitioners, government officials, and lawmakers. Second, the State Food and Drug Administration should raise the requirements for Chinese Medicine Injection (CMI) registration and license approval and emphasize the importance of evidence-based CMI development and evidence-based CMI license approval. Thirdly, drug companies and institutions should reinforce basic research about the quality control of herbs and CMI-drug interactions. Fourth, the Government should clarify the legal responsibilities for CMI approval agencies, CMI developers, medical doctors, and patients. Fifth, the medical association and Government should enhance training for health care professionals concerning the usage of CMIs. And finally sixth, State Food and Drug Administration should monitor the content and quality of the directions for use of CMI.
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。
高質量的隨機對照試驗（randomized controlled trials，RCTs）是循證醫學的組成部分。隨機對照試驗是高質量系統評價的基礎，是衛生保健政策和臨床實踐的重要決定因素。為最有效地使用已發表的研究，研究者和作者應遵循準確和透明的 RCTs 報告規范。CONSORT 聲明及其擴展版是生物醫學研究中使用最廣泛的報告規范之一。CONTORT 聲明于 2004 年被 American Journal of Orthodontics and Dentofacial Orthopedics 采用。自 2011 年以來，該期刊一直積極遵守 CONSORT 報告規范。本文旨在解釋 CONSORT 各條目與這一領域研究報告的相關性及其應用，以幫助作者向本雜志和其他矯正類雜志提交 RCTs 報告時，達到 CONSORT 聲明的要求。