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.
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.
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.
Scientism and humanism are two main views on the development of medicine, which run through both theory and practice. Under the guidance of the modern medical concept of " bio-psycho-social”, the views of scientism and humanism on medicine have reached an unprecedented level of development and integration, which jointly determine the connotations and demands of current medicine. As one of the current mainstream medical models, evidence-based medicine (EBM) has played an important role in the management of current medical theories and practices. Meanwhile, EBM has also encompassed views of scientism and humanism in its own development and has successfully shaped the knowledge and methodological system. EBM will continue to gain insight into the characteristics of views of scientism and humanism in the future of medicine to improve itself and should pay more attention to the development of humanism view. As an important branch discipline of EBM, evidence-based Chinese medicine may become a model of the perfect combination of scientism view and humanism view.
随机对照试验报告规范声明（consolidated standards of reporting trials，CONSORT）是一个旨在提高随机对照试验（randomized controlled trial，RCT）报告透明度和质量的指南。本扩展版针对将来确定性 RCT 之前所进行的随机先导性和可行性试验制定统一报告规范。该清单适用于任何随机研究，其中包括确定性 RCT 及此前的、在小规模研究样本下进行的任何先导性试验，而其设计（如聚类、析因、交叉）或作者用来描述该研究的术语（如先导性（试验）、可行性（试验）、试验、研究）并不会对此造成影响。不过，需要注意的是，本报告规范扩展范围不直接适用于主要试验设计中内置的先导性试验、非随机的先导性和可行性试验，或者Ⅱ期临床试验。不过这些研究都与随机先导性和可行性试验有一定相似性，因此许多原则也同样适用。本扩展版的研发是因为越来越多的研究被描述为可行性试验或先导性试验，但这些研究的报告和实施存在缺陷。我们遵循了所推荐的良好实践来研发 CONSORT 先导性和可行性试验扩展版，其中包括进行德尔菲调查、召开共识会议和研究团队会议及试行此条目清单等。由于先导性试验和可行性随机试验的目的和目标不同于其他随机试验，因此，尽管在这些试验报告中的许多内容，与评估效果和效力的 RCT 中的报告内容相似，但在报告内容类型、报告条目解释方面，其与标准 CONSORT 存在一些关键差异。本文保留了部分标准 CONSORT 声明的条目，但仔细阅读就会发现，其中大多数条目已经被修改或删除，并且添加了一些新的条目。其中，新增条目包括：如何识别受试者并获得同意；如果适用，用于判断是否或如何进行将来确定性 RCT 的预先制定的标准；如果相关，其他重要的非预期结果；先导性试验的结果对将来确定性 RCT 的影响，还包括任何拟定的修正及伦理批准或研究审查委员会的批准，并要求附有获准批号。本扩展版包括 26 个条目清单、摘要的单独清单、研究的流程图模板及对所做条目更改的解释和相关范例。我们相信，使用 CONSORT 先导性和可行性试验扩展版，将提高先导性试验的报告质量。
背景 基于仿真研究（simulation-based research，SBR）的数量迅速增加，但是这类研究的报告质量却需亟待提高。为使读者能够批判性地评估研究，研究报告的要素需要在文章中清晰地报告出来。我们旨在通过扩展试验报告的统一标准（Consolidated Standards of Reporting Trial，CONSORT）和加强流行病学观察性研究报告（Strengthening the Reporting of Observational Studies in Epidemiology，STROBE）声明来制定卫生保健仿真研究的报告规范。 方法 在制定报告规范的建议步骤基础上，使用迭代的多步共识法建立流程。多步共识法包括以下内容：① 建立指导委员会；② 定义报告规范的范围；③ 确定共识小组参与者；④ 通过在线会前调查生成拟讨论项目清单；⑤ 召开共识会议；⑥ 起草报告规范及解释与说明文件。 结果 对 CONSORT 的 11 个条目进行了扩展，包括条目 1（文题和摘要），条目 2（背景），条目 5（干预措施），条目 6（结局指标），条目 11（盲法），条目 12（统计方法），条目 15（基线数据），条目 17（结果和估计值），条目 20（局限性），条目 21（可推广性）和条目 25（资金来源）。对 STROBE 的 10 个条目进行了扩展：条目 1（文题和摘要），条目 2（背景/原理），条目 7（变量），条目 8（数据来源/数据测量），条目 12（统计方法），条目 14（描述性数据），条目 16（主要结果），条目 19（局限性），条目 21（可推广性）和条目 22（资金来源）。工作组已创建详细说明文档，提供每个扩展条目的示例和说明。 结论 制订基于 CONSORT 和 STROBE 声明的仿真研究扩展版，可帮助提高仿真研究的报告质量。