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.
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.
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.
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.
Evidence-based medicine (EBM) provides a reliable evidence decision-making model for the medical field. The concepts and methods of EBM are gradually extended to other disciplines. At present, the paradigm of evidence-based science (EBS) is formally proposed, which is not only based on a methodological cooperation between different disciplines, but also a deeper potential driving force in optimizing the operation process of knowledge. The advantages of EBS helps promote its extension to other disciplines through standardization concepts and systematic methods, through which the common theories and supporting organization of EBS are formed. Under the guideline of EBS, the evidence-based concepts and methods will play a supportive role in scientific development.
隨機對照試驗報告規范聲明（consolidated standards of reporting trials，CONSORT）是一個旨在提高隨機對照試驗（randomized controlled trial，RCT）報告透明度和質量的指南。本擴展版針對將來確定性 RCT 之前所進行的隨機先導性和可行性試驗制定統一報告規范。該清單適用于任何隨機研究，其中包括確定性 RCT 及此前的、在小規模研究樣本下進行的任何先導性試驗，而其設計（如聚類、析因、交叉）或作者用來描述該研究的術語（如先導性（試驗）、可行性（試驗）、試驗、研究）并不會對此造成影響。不過，需要注意的是，本報告規范擴展范圍不直接適用于主要試驗設計中內置的先導性試驗、非隨機的先導性和可行性試驗，或者Ⅱ期臨床試驗。不過這些研究都與隨機先導性和可行性試驗有一定相似性，因此許多原則也同樣適用。本擴展版的研發是因為越來越多的研究被描述為可行性試驗或先導性試驗，但這些研究的報告和實施存在缺陷。我們遵循了所推薦的良好實踐來研發 CONSORT 先導性和可行性試驗擴展版，其中包括進行德爾菲調查、召開共識會議和研究團隊會議及試行此條目清單等。由于先導性試驗和可行性隨機試驗的目的和目標不同于其他隨機試驗，因此，盡管在這些試驗報告中的許多內容，與評估效果和效力的 RCT 中的報告內容相似，但在報告內容類型、報告條目解釋方面，其與標準 CONSORT 存在一些關鍵差異。本文保留了部分標準 CONSORT 聲明的條目，但仔細閱讀就會發現，其中大多數條目已經被修改或刪除，并且添加了一些新的條目。其中，新增條目包括：如何識別受試者并獲得同意；如果適用，用于判斷是否或如何進行將來確定性 RCT 的預先制定的標準；如果相關，其他重要的非預期結果；先導性試驗的結果對將來確定性 RCT 的影響，還包括任何擬定的修正及倫理批準或研究審查委員會的批準，并要求附有獲準批號。本擴展版包括 26 個條目清單、摘要的單獨清單、研究的流程圖模板及對所做條目更改的解釋和相關范例。我們相信，使用 CONSORT 先導性和可行性試驗擴展版，將提高先導性試驗的報告質量。