Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research
Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research
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道德标准 (HRPP) 和公共合作 (PARTAKE) 旨在解决印度的临床研究问题：迈向道德、负责任、文化敏感和社区参与的临床研究
DOI：
10.4172/2155-9627.1000195
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发表时间：
2014
期刊：
影响因子：
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通讯作者：
M. Speers
中科院分区：
文献类型：
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作者：
T. Burt;Y. Gupta;N. Mehta;Nagendra Swamy;V. Sovani;M. Speers
与其他新兴经济体一样，印度对独立、循证和负担得起的医疗保健的追求导致了临床研究部门的强劲增长，2005年至2010年的复合年增长率（CAGR）为20.4%。然而，尽管基本驱动力和优势仍然强劲，但在过去几年中，由于监管问题、维权人士抗议和赞助商离职，赞助商的年复合增长率呈下降趋势（CAGR-16.7%）。尽管印度占世界人口的17.5%，但目前仅进行了1%的临床试验。2013年6月，印度和国际专家以及公众利益相关者在新德里举行了为期两天的会议，讨论印度临床研究面临的挑战并探索解决方案。讨论的主题是道德标准、监管监督以及与公共利益攸关方的伙伴关系。这次会议是AAHRPP（人类研究保护计划认证协会）和PARTAKE（通过知识和授权促进治疗进步的公众意识研究）的合作，旨在建立负责任和道德的临床研究标准，旨在向公众提供信息并参与临床研究。本文涵盖了印度最近的临床研究进展以及相关的期望，挑战和未来方向的建议。AAHRPP和PARTAKE提供基于病因的解决方案，以保护，告知和吸引公众和医学研究赞助商。
Like other emerging economies, India’s quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR −16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world’s population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)—aimed at establishing responsible and ethical clinical research standards—and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)—aimed at informing and engaging the public in clinical research. The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors.