National Institute of Environmental Health Sciences/National Institutes of Health, Division of Extramural Research, Research Triangle Park, NC 27709, United States.
Reprod Toxicol. 2013 Sep;40:35-40. doi: 10.1016/j.reprotox.2013.05.010. Epub 2013 Jun 5.
Recently, medical research has seen a strong push toward translational research, or "bench to bedside" collaborations, that strive to enhance the utility of laboratory science for improving medical treatment. The success of that paradigm supports the potential application of the process to other fields, such as risk assessment. Close collaboration among academic, government, and industry scientists may enhance the translation of scientific findings to regulatory decision making. The National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively academic and guideline-compliant research. An initial proof-of-concept collaboration, the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA), uses bisphenol A (BPA) as a test chemical. The CLARITY-BPA program combines a core perinatal guideline-compliant 2-year chronic toxicity study with mechanistic studies/endpoints conducted by academic investigators. Twelve extramural grantees were selected by NIEHS through an RFA-based initiative to participate in the overall study design and conduct disease-relevant investigations using tissues and animals from the core study. While the study is expected to contribute to our understanding of potential effects of BPA, it also has ramifications beyond this specific focus. Through CLARITY-BPA, NIEHS has established an unprecedented level of collaboration among extramural grantees and regulatory researchers. By drawing upon the strengths of academic and regulatory expertise and research approaches, CLARITY-BPA represents a potential new model for filling knowledge gaps, enhancing quality control, informing chemical risk assessment, and identifying new methods or endpoints for regulatory hazard assessments.
最近，医学研究领域强烈推动转化研究，即“从实验室到病床”的合作，努力增强实验室科学在改善医疗方面的实用性。这一模式的成功支持了将该过程应用于其他领域的潜力，例如风险评估。学术、政府和工业界科学家之间的密切合作可能会增强将科学发现转化为监管决策的能力。国家毒理学计划（NTP）、国家环境卫生科学研究所（NIEHS）和美国食品和药物管理局（FDA）开发了一个基于联盟的研究计划，以更有效地将学术和符合指导原则的研究联系起来。作为一个初步的概念验证合作，“将学术和监管对 BPA 毒性的见解联系起来的联盟”（CLARITY-BPA）使用双酚 A（BPA）作为测试化学品。CLARITY-BPA 计划将符合核心围产期指导原则的为期 2 年的慢性毒性研究与由学术研究人员进行的机制研究/终点相结合。NIEHS 通过基于 RFA 的倡议选择了 12 个校外赠款，以参与总体研究设计并使用核心研究中的组织和动物进行与疾病相关的调查。虽然该研究有望有助于我们了解 BPA 的潜在影响，但它也超越了这一特定焦点。通过 CLARITY-BPA，NIEHS 在校外赠款和监管研究人员之间建立了前所未有的合作水平。通过利用学术和监管专业知识和研究方法的优势，CLARITY-BPA 代表了一种潜在的新模式，可以填补知识空白、增强质量控制、为化学风险评估提供信息，并确定新的方法或终点用于监管危害评估。
