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.
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。
草药产品被广泛使用，其成分及质量差异很大，在随机对照试验（randomized controlled trials，RCTs）中也十分常见。笔者基于 22 项 CONSORT 条目清单，对含草药干预措施 RCTs 的报告内容提出推荐条目。经过电话沟通，笔者于加拿大多伦多与 16 位专家进行了专家共识会议。工作组通过了 9 项草药 RCTs 的 CONSORT 清单条目，其中针对草药干预措施的条目 4 阐述最为详尽。这些推荐将会用于改善草药干预措施 RCTs 的报告。
高质量的随机对照试验（randomized controlled trials，RCTs）是循证医学的组成部分。随机对照试验是高质量系统评价的基础，是卫生保健政策和临床实践的重要决定因素。为最有效地使用已发表的研究，研究者和作者应遵循准确和透明的 RCTs 报告规范。CONSORT 声明及其扩展版是生物医学研究中使用最广泛的报告规范之一。CONTORT 声明于 2004 年被 American Journal of Orthodontics and Dentofacial Orthopedics 采用。自 2011 年以来，该期刊一直积极遵守 CONSORT 报告规范。本文旨在解释 CONSORT 各条目与这一领域研究报告的相关性及其应用，以帮助作者向本杂志和其他矫正类杂志提交 RCTs 报告时，达到 CONSORT 声明的要求。