title: A new approach to synergize academic and guideline-compliant research: the CLARITY-BPA research program.
abstract: 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.
authors.affiliation: National Institute of Environmental Health Sciences/National Institutes of Health, Division of Extramural Research, Research Triangle Park, NC 27709, United States. Schugt@niehs.nih.gov
authors.forename: Thaddeus T
authors.initials: TT
authors.lastname: Schug
authors.forename: Jerrold J
authors.initials: JJ
authors.lastname: Heindel
authors.forename: Luísa
authors.initials: L
authors.lastname: Camacho
authors.forename: K Barry
authors.initials: KB
authors.lastname: Delclos
authors.forename: Paul
authors.initials: P
authors.lastname: Howard
authors.forename: Anne F
authors.initials: AF
authors.lastname: Johnson
authors.forename: Jason
authors.initials: J
authors.lastname: Aungst
authors.forename: Dennis
authors.initials: D
authors.lastname: Keefe
authors.forename: Retha
authors.initials: R
authors.lastname: Newbold
authors.forename: Nigel J
authors.initials: NJ
authors.lastname: Walker
authors.forename: R
authors.initials: R
authors.lastname: Thomas Zoeller
authors.forename: John R
authors.initials: JR
authors.lastname: Bucher
mesh_terms: D000818:Animals; D001559:Benzhydryl Compounds / Q000633:toxicity*; D003299:Cooperative Behavior; D004968:Estrogens, Non-Steroidal / Q000633:toxicity*; D019983:Guideline Adherence; D006801:Humans; D054585:National Institute of Environmental Health Sciences (U.S.); D010636:Phenols / Q000633:toxicity*; D012107:Research Design / Q000592:standards*; D018570:Risk Assessment / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration; D000098826:Bisphenol A Compounds
chemical_list: D001559:Benzhydryl Compounds; D004968:Estrogens, Non-Steroidal; D010636:Phenols; C006780:bisphenol A; D000098826:Bisphenol A Compounds
keywords: Bisphenol A; Consortium-based research; FDA; Low dose; NIEHS; NTP