LEADER 04949nam 2200625 450 001 9910787440803321 005 20230803212547.0 010 $a0-309-31003-2 010 $a0-309-31001-6 035 $a(CKB)3710000000336166 035 $a(EBL)3379407 035 $a(SSID)ssj0001467018 035 $a(PQKBManifestationID)11892276 035 $a(PQKBTitleCode)TC0001467018 035 $a(PQKBWorkID)11504063 035 $a(PQKB)11321513 035 $a(MiAaPQ)EBC3379407 035 $a(Au-PeEL)EBL3379407 035 $a(CaPaEBR)ebr11003355 035 $a(OCoLC)904080937 035 $a(EXLCZ)993710000000336166 100 $a20150121h20142014 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aCharacterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products $eworkshop summary /$fDenise Caruso, Rebecca A. English, Anne B. Claiborne 210 1$aWashington, District of Columbia :$cThe National Academies Press,$d2014. 210 4$dİ2014 215 $a1 online resource (150 p.) 300 $aDescription based upon print version of record. 311 $a0-309-31000-8 320 $aIncludes bibliographical references. 327 $a""Front Matter""; ""Reviewers""; ""Contents""; ""Boxes, Figures, and Table""; ""Acronyms""; ""1 Introduction""; ""2 Identifying and Characterizing Uncertainty""; ""3 The Regulators Challenge""; ""4 Basic Methodologies and Applications for Understanding and Evaluating Uncertainty""; ""5 Communicating Uncertainty""; ""6 Final Reflections on Ways to Characterize and Communicate Uncertainty""; ""References""; ""Appendix A: Workshop Agenda""; ""Appendix B: FDA Case Studies""; ""Appendix C: Bibliography""; ""Appendix D: Participant Biographies"" 330 $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. 606 $aRisk assessment$vCongresses 606 $aCommunication$vCongresses 615 0$aRisk assessment 615 0$aCommunication 676 $a363.1 700 $aCaruso$b Denise$01545137 702 $aEnglish$b Rebecca A. 702 $aClaiborne$b Anne B. 712 02$aBoard on Health Sciences Policy. 712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation. 712 02$aInstitute of Medicine (U.S.) 712 12$aCharacterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products (Workshop)$f(2014 :$eWhite Oak, Md.), 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910787440803321 996 $aCharacterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products$93799892 997 $aUNINA