Coverart for item
The Resource Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products : workshop summary, Denise Caruso, Rebecca A. English, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies, (electronic resource)

Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products : workshop summary, Denise Caruso, Rebecca A. English, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies, (electronic resource)

Label
Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products : workshop summary
Title
Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products
Title remainder
workshop summary
Statement of responsibility
Denise Caruso, Rebecca A. English, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
Creator
Contributor
Subject
Genre
Language
eng
Summary
  • "Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle"--
  • "Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle"--
Assigning source
  • Publisher's description
  • Publisher's description
Cataloging source
UNL
http://library.link/vocab/creatorDate
1956-
http://library.link/vocab/creatorName
Caruso, Denise
Dewey number
362.17820973
LC call number
RA401.A3
LC item number
C375 2014
http://library.link/vocab/relatedWorkOrContributorDate
2014
http://library.link/vocab/relatedWorkOrContributorName
  • English, Rebecca A
  • Claiborne, Anne B
  • Institute of Medicine (U.S.)
  • Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products (Workshop)
http://library.link/vocab/subjectName
  • Pharmaceutical policy
  • Drugs
  • Drugs
  • Drugs
  • Drugs
  • Pharmaceutical Preparations
  • Risk Assessment
  • Communication
  • Drug Industry
Label
Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products : workshop summary, Denise Caruso, Rebecca A. English, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies, (electronic resource)
Instantiates
Publication
Bibliography note
Includes bibliographical references (pages 67-69)
Contents
  • Introduction -- Identifying and characterizing uncertainty -- The regulators' challenge -- Basic methodologies and applications for understanding and evaluating uncertainty -- Communicating uncertainty -- Final reflections on ways to characterize and communicate uncertainty
  • Introduction -- Identifying and characterizing uncertainty -- The regulators' challenge -- Basic methodologies and applications for understanding and evaluating uncertainty -- Communicating uncertainty -- Final reflections on ways to characterize and communicate uncertainty
Control code
OCM1bookssj0001467018
Dimensions
unknown
Isbn
9780309310000
Isbn Type
(pbk.)
Lccn
2015304743
Note
Electronic reproduction. Palo Alto, Calif. : ebrary, 2015. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.
Specific material designation
remote
System control number
(WaSeSS)bookssj0001467018
Label
Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products : workshop summary, Denise Caruso, Rebecca A. English, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies, (electronic resource)
Publication
Bibliography note
Includes bibliographical references (pages 67-69)
Contents
  • Introduction -- Identifying and characterizing uncertainty -- The regulators' challenge -- Basic methodologies and applications for understanding and evaluating uncertainty -- Communicating uncertainty -- Final reflections on ways to characterize and communicate uncertainty
  • Introduction -- Identifying and characterizing uncertainty -- The regulators' challenge -- Basic methodologies and applications for understanding and evaluating uncertainty -- Communicating uncertainty -- Final reflections on ways to characterize and communicate uncertainty
Control code
OCM1bookssj0001467018
Dimensions
unknown
Isbn
9780309310000
Isbn Type
(pbk.)
Lccn
2015304743
Note
Electronic reproduction. Palo Alto, Calif. : ebrary, 2015. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.
Specific material designation
remote
System control number
(WaSeSS)bookssj0001467018

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