Promoting good health research practice in low- and middle-income countries
Promoting good health research practice in low- and middle-income countries
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DOI：
10.3402/gha.v9.32474
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发表时间：
2016-01-01
影响因子：
2.6
通讯作者：
Elango, Varalakshmi
中科院分区：
文献类型：
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作者：
Mahendradhata, Yodi;Nabieva, Jamila;Elango, Varalakshmi
背景资料：药物临床试验质量管理规范（GCP）指南一直是提高临床试验质量的源泉;然而，在行业申办的临床试验以外的健康研究中，GCP的应用存在局限性。儿童基金会/开发计划署/世界银行/卫生组织热带疾病研究和培训特别方案正在通过良好卫生研究做法培训方案倡议，促进所有涉及人类的卫生研究的良好做法。报告GHRP培训计划试点的结果，并制定进一步的措施，以利用GHRP促进所有涉及人类的健康研究的良好做法，设计：本培训的目的是传授知识和技能，以便将伦理和质量原则应用于基于风险水平的涉及人类参与者的健康研究的设计、实施、记录和报告，以确保质量体系符合目的。这已被制定为五个连续的模块，将在为期4天的课程交付。在试点阶段（2014-2015年）举办了四期课程。课程进行了评估和评估的基础上，课程实施过程中收集的反馈（定量和定性数据）和定性的电子邮件为基础的前和后课程evaluation.Results：与会者非常满意的课程内容及其组织。课程内容的相关性和适用性带来了积极的反馈，并明确表示愿意调整和传播课程。行动点，以加强培训计划已被确定，并显示迫切需要制定一个共识，与更广泛的关键利益相关者的最终一套GHRP标准和手段的implementation.Conclusions：有迫切需要利用的势头，以促进高质量和道德的健康研究，通过扩大GHRP培训和GHRP原则进一步发展成国际标准，在LMICs。
Background: Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative.Objective: To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs).Design: The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014-2015). The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data) collected during course implementation and qualitative email-based pre- and post-course evaluation.Results: Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation.Conclusions: There is an urgent need to harness the momentum to promote high-quality and ethical health research in LMICs through scaling up GHRP training and further development of GHRP principles into international standards.