title: Regulatory decision-making meets the real world.
abstract: As patient input in drug development increases and new data sources are tapped, regulators need to organize and ensure the quality of data to inform decision-making.
authors.affiliation: Friends of Cancer Research, 1800 M Street, NW, Washington, DC 20036, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Hohman
authors.affiliation: Friends of Cancer Research, 1800 M Street, NW, Washington, DC 20036, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Shea
authors.affiliation: Friends of Cancer Research, 1800 M Street, NW, Washington, DC 20036, USA.
authors.forename: Marina
authors.initials: M
authors.lastname: Kozak
authors.affiliation: Friends of Cancer Research, 1800 M Street, NW, Washington, DC 20036, USA.
authors.forename: Samantha
authors.initials: S
authors.lastname: Roberts
authors.affiliation: Friends of Cancer Research, 1800 M Street, NW, Washington, DC 20036, USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Allen
authors.affiliation: Friends of Cancer Research, 1800 M Street, NW, Washington, DC 20036, USA. esigal@focr.org.
authors.forename: Ellen
authors.initials: E
authors.lastname: Sigal
mesh_terms: D003219:Confidentiality / Q000331:legislation & jurisprudence; D003657:Decision Making; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D010358:Patient Participation; D014481:United States; D014486:United States Food and Drug Administration