Group of Health Technology Assessment, Institute of Molecular Immunology, Havana, Cuba.
Research Department, Joaquin Castillo Duany's Hospital, Santiago de Cuba, Cuba.
Int J Health Policy Manag. 2018 Jul 1;7(7):623-629. doi: 10.15171/ijhpm.2017.140.
The management of drug safety with the collection of reliable safety data during the conduction of clinical trials conduct is essential for the registry and marketing of products. The systematic evaluation of this process, based on objective measures, requires the application of quality instruments. This study was aimed to design and validate eight instruments through the components of quality (structure, process, and results), for characterizing and assessing the process of drug safety management, during the conduction of clinical trials.
The eight instruments were designed according to the international recommendations for Good Clinical Practice (GCP) and comprise a knowledge survey for professionals at the investigational sites, a satisfaction scale of internal and external clients and a satisfaction survey for patients with the treatment of the adverse events. The instruments also include a checklist to evaluate the safety management infrastructure (human, material and organizational resources) in the sponsoring center, a checklist to evaluate the same criterion at the investigational sites and three checklists that evaluate adherence to regulatory requirements of essential documents (investigator's brochure, protocol, and informed consent form). The content validity was evaluated by Delphi method and the reliability was determined by Cronbach α test.
All the items were valued as very adequate after the second round of the expert panel. The instruments were deemed as appropriate and understandable in the pre-test performed. All responders agreed with the options given and the accessibility of the application. Only 10% of professionals at the research sites suggested that the knowledge survey was too long. Cronbach α values between .66 and .93 were obtained.
The structure, process, and outcome framework allowed for the characterization of drug safety management during clinical trials, providing a useful approach for the promoter to systematically measure and evaluate the process. The eight instruments were deemed as reliable, feasible and easy to be used for examining drug safety management while carrying out clinical trials.
在临床试验进行过程中收集可靠的安全性数据对于产品的注册和上市至关重要。基于客观指标的这一过程的系统评估需要应用质量工具。本研究旨在设计并验证 8 种工具，通过质量（结构、过程和结果）的组成部分，对临床试验进行过程中的药物安全管理进行特征描述和评估。
根据国际良好临床规范（GCP）的建议设计了这 8 种工具，包括调查点专业人员的知识调查、内部和外部客户的满意度量表以及对接受不良事件治疗的患者的满意度调查。这些工具还包括一个检查表，用于评估赞助中心的安全管理基础设施（人力、物力和组织资源），一个检查表，用于评估调查点的相同标准，以及三个检查表，用于评估对基本文件（研究者手册、方案和知情同意书）监管要求的遵守情况。内容有效性通过 Delphi 方法进行评估，可靠性通过 Cronbach α 测试确定。
在专家小组第二轮投票后，所有项目都被评为非常充分。在进行的预测试中，这些工具被认为是合适和易于理解的。所有回应者都同意所提供的选项和应用程序的可访问性。只有 10%的研究点的专业人员认为知识调查太长。Cronbach α 值在.66 到.93 之间。
结构、过程和结果框架允许对临床试验期间的药物安全管理进行特征描述，为发起人提供了一种有用的方法来系统地衡量和评估这一过程。这 8 种工具被认为是可靠、可行且易于在进行临床试验时用于检查药物安全管理。
