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.
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.
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.
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.
若在已发表的报告中干预措施描述不完整，临床工作者和患者就无法可靠地实施有效的干预措施，其他研究人员也无法在此研究基础上重复或进一步开展研究。然而，已发表文章中干预措施的报告质量非常差。为提高报告的完整性并最终提高干预措施的可重复性，一个国际专家组和利益相关方共同制订了描述干预措施的清单和报告规范（Template for Intervention Description and Replication，TIDieR）。制订过程包括：相关清单和研究的文献综述，针对国际专家小组的德尔菲调查以指导选择清单条目及召开面对面的小组会议。最终确定的 12 条 TIDieR 清单条目（包括：干预措施简称、实施理由、实施资料、实施过程、干预措施实施者、实施方法、实施地点、实施时间及强度、个性化方案、方案更改、预期效果和实际效果）是对 CONSORT（The Consolidated Standards of Reporting Trials）2010 声明中条目 5 和 SPIRIT（Standard Protocol Items: Recommendations for Interventional Trials）2013 声明中条目 11 的扩展。虽然该清单强调的是试验中干预措施描述，但该指导仍适用于所有评价性研究设计。本文对 TIDieR 清单的每个条目进行了解释和说明并呈现了高质量报告的实例。TIDieR 清单和报告规范可提高干预措施的报告质量，并且使得作者对干预措施的描述、审稿人和编辑对有关干预措施描述的评估、读者对干预措施的使用更加容易。
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。
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.