MARC Record from Library of Congress

LEADER: 04861cam a22004937i 4500
001 2015304743
003 DLC
005 20150618082527.0
008 150602t20142014dcua b f100 0 eng d
010 $a 2015304743
020 $a9780309310000 (pbk.)
020 $a0309310008 (pbk.)
035 $a(OCoLC)ocn899248711
040 $aUNL$beng$cUNL$erda$dNRZ$dKSU$dIXA$dYDXCP$dDLC
042 $alccopycat
043 $an-us---
050 00 $aRA401.A3$bC375 2014
082 04 $a362.17820973$223
100 1 $aCaruso, Denise,$d1956-$erapporteur.
245 10 $aCharacterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products :$bworkshop summary /$cDenise 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.
264 1 $aWashington, D.C. :$bThe National Academies Press,$c[2014]
264 4 $c©2014
300 $axvi, 134 pages :$billustrations (some color) ;$c23 cm.
336 $atext$btxt$2rdacontent
337 $aunmediated$bn$2rdamedia
338 $avolume$bnc$2rdacarrier
520 $a"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"--$cPublisher's description.
504 $aIncludes bibliographical references (pages 67-69).
505 0 $aIntroduction -- 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.
530 $aAlso available via the World Wide Web.
650 0 $aPharmaceutical policy$zUnited States$xDecision making$vCongresses.
650 0 $aDrugs$xLaw and legislation$zUnited States$xDecision making$vCongresses.
650 0 $aDrugs$xRisk assessment$zUnited States$xDecision making$vCongresses.
650 0 $aDrugs$xTesting$xGovernment policy$zUnited States$vCongresses.
650 0 $aDrugs$xTesting$xLaw and legislation$zUnited States$vCongresses.
650 12 $aPharmaceutical Preparations$vCongresses.
650 12 $aRisk Assessment$vCongresses.
650 22 $aCommunication$vCongresses.
650 22 $aDrug Industry$xstandards$vCongresses.
700 1 $aEnglish, Rebecca A.,$erapporteur.
700 1 $aClaiborne, Anne B.,$erapporteur.
710 2 $aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation.
711 2 $aCharacterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products (Workshop)$d(2014 :$cWhite Oak, Md.),$jauthor.
856 41 $3National Academies Press$uhttp://www.nap.edu/openbook.php?record_id=18870