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.
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.
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.
背景 随机对照试验（randomized controlled trials，RCTs）常用于评估社会和心理干预措施的效果，这些结果亦常被用于制定决策。有关社会及心理干预措施试验结果的准确、完整和透明的报告，对了解针对这些干预措施的临床试验设计、实施、结果及这些结果的应用至关重要。然而，关于社会和心理干预措施的 RCT 报告质量仍不理想。CONSORT（consolidated standards of reporting trials）声明改善了生物医学领域 RCT 的报告质量，同样，行为和社会科学方面也需要类似的高质量报告规范。我们的目标是基于 RCT 报告规范 2010 年声明（Consolidated Standards of Reporting Trials 2010 Statement，CONSORT 2010）的官方扩展版，制定适用于社会和心理干预措施（social and psychological interventions，SPI）的 RCT 报告规范（CONSORT-SPI 2018）。 方法 我们遵循最佳方案制定报告规范的扩展版。首先，我们对现有报告规范进行了系统评价。随后，我们进行了有 384 位国际参与者参加的德尔菲在线调查。2014 年 3 月，我们举行了为期 3 天的共识会议，由 31 位专家参与，确定针对社会和心理干预措施的 RCT 报告的检查清单内容。专家们仔细讨论了先前与社会和心理干预措施 RCT 相关的研究和方法学问题。然后，投票决定对 CONSORT 2010 条目的修改或扩展。 结果 CONSORT-SPI 2018 检查清单扩展了 CONSORT 2010 的 25 个条目中的 9 个，包括：背景和目标、试验设计、受试者、干预措施、统计方法、受试者流程、基线数据、结果和估计及资助来源。此外，与会者还添加了一个与利益相关方参与度有关的新条目，此外，也修改了与受试者招募和及其后续维持相关的流程图。 结论 作者应使用 CONSORT-SPI 2018 来改善社会和心理干预相关的 RCT 的报告质量。期刊应修改编辑政策和程序，要求作者使用报告规范准备相关稿件，要求同行评议者使用报告规范评审相关稿件，以使读者能够评估研究的质量，评价研究结果的推广性，并重复有效的干预措施。
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。