Inclusivity and diversity: Integrating international perspectives on stem cell challenges and potential.
Inclusivity and diversity: Integrating international perspectives on stem cell challenges and potential.
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包容性和多样性：整合关于干细胞挑战和潜力的国际观点。
DOI：
10.1016/j.stemcr.2021.07.003
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发表时间：
2021-08-10
影响因子：
5.9
通讯作者：
Meulen VT
中科院分区：
文献类型：
--
作者：
Fears R;Akutsu H;Alentajan-Aleta LT;Caicedo A;Campos de Carvalho AC;Čolić M;Cornish J;Cossu G;Debré P;Dierckxsens G;El-Badri N;Griffin G;Chingo-Ho Hsieh P;Inamdar MS;Kumar P;Abraham CM;Maciulaitis R;Al Mahtab M;O'Brien FJ;Pepper MS;Meulen VT
再生医学具有巨大的潜力。科学进步的步伐令人兴奋，再生和修复的医疗机会可能是变革性的。然而，人们对以下两方面问题的关注继续增加：一是无良的私人诊所在很少或没有证据的基础上提供不受管制的疗法，二是在科学依据和临床证据不足的基础上过早批准监管机构的做法。国际科学院合作组织（InterAcademy Partnership）发起了一项倡议，召集世界各地的专家，以干细胞为重点，确定机遇和挑战。其目的是具有包容性，协商一致的产出反映了全球研究人口的多样性。在保护患者的同时支持研究和创新的问题包括伦理评估；临床前和临床研究；监管授权和药品获取；以及与患者、政策制定者和公众的接触。国际科学院伙伴关系（IAP）确定了在科学界内部以及与全球其他利益攸关方分享良好做法和建立合作的行动方案。一项包容性IAP研究考察了全球干细胞的机遇和挑战。巨大的潜力导致了对不受监管的诊所证据基础的担忧，也导致了对缺乏充分证据的过早监管批准的担忧。在这篇文章中，Fears及其同事描述了国际科学院合作组织（InterAcademy Partnership）提出的一项包容性全球倡议，该倡议考察了干细胞的机遇和挑战。巨大的治疗潜力带来了对不受监管的诊所使用的证据基础不足的担忧。人们还对监管部门在没有充分证据的情况下过早批准表示担忧。建议包括道德评估；临床前和临床研究；监管授权和药品获取；以及与患者、政策制定者和公众的接触。
Regenerative medicine has great potential. The pace of scientific advance is exciting and the medical opportunities for regeneration and repair may be transformative. However, concerns continue to grow, relating to problems caused both by unscrupulous private clinics offering unregulated therapies based on little or no evidence and by premature regulatory approval on the basis of insufficient scientific rationale and clinical evidence. An initiative by the InterAcademy Partnership convened experts worldwide to identify opportunities and challenges, with a focus on stem cells. This was designed to be inclusive and consensus outputs reflected the diversity of the global research population. Among issues addressed for supporting research and innovation while protecting patients were ethical assessment; pre-clinical and clinical research; regulatory authorization and medicines access; and engagement with patients, policy makers, and the public. The InterAcademy Partnership (IAP) identified options for action for sharing good practice and building collaboration within the scientific community and with other stakeholders worldwide. An inclusive IAP study examined global stem cell opportunities and challenges Great potential leads to concerns for evidence base in unregulated clinics Also concerns for premature regulatory approval without sufficient evidence Recommendations for responsible research and innovation and collaborations In this article, Fears and colleagues describe an inclusive global initiative by the InterAcademy Partnership examining stem cell opportunities and challenges. Great therapeutic potential brings concerns about the inadequate evidence base used by unregulated clinics. Concerns are also expressed about premature regulatory approval without sufficient evidence. Recommendations cover ethical assessment; pre-clinical and clinical research; regulatory authorization and medicines access; and engagement with patients, policy makers, and the public.
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影响因子：
10
作者：
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通讯作者：
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影响因子：
7.2
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2.2
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