MARC Record from marc_columbia

LEADER: 06322cam a2200481Ii 4500
001 13220191
005 20180523155003.0
008 180219t20182018dcua b 100 0 eng d
020 $a9780309457941$q(paperback)
020 $a0309457947$q(paperback)
035 $a(OCoLC)on1023546386
035 $a(OCoLC)1023546386
035 $a(NNC)13220191
040 $aYDX$beng$erda$cYDX$dNRC$dSOI$dOCLCF$dKSU
050 4 $aRM301.27$b.D78 2018
111 2 $aDrug Development Paradigm in Oncology (Workshop)$d(2016 :$cWashington, D.C.),$jauthor.
245 14 $aThe Drug Development Paradigm in Oncology : proceedings of a workshop /$cAmanda Wagner Gee, Erin Balogh, Margie Patlak, and Sharyl J. Nass, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine.
264 1 $aWashington, DC :$bNational Academies Press,$c[2018]
264 4 $c©2018
300 $axxii, 121 pages :$bcolor illustrations ;$c23 cm
336 $atext$btxt$2rdacontent
337 $aunmediated$bn$2rdamedia
338 $avolume$bnc$2rdacarrier
520 $a"Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of efforts--by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)--to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop"--Publisher's description.
504 $aIncludes bibliographical references.
505 0 $aIntroduction -- Background on drug development and regulatory review. Types of FDA drug development and approval pathways -- Ethical requirements of clinical research -- Exploring the challenges with traditional clinical drug development. Inefficiencies and long development timelines -- Generalizability of clinical trial results to clinical practice -- Appropriate use of biomarkers and surrogate endpoints -- Finding the right dose -- New strategies in oncology drug development. Patient-centered drug development -- Informed consent -- Patient risk -- Mechanism-informed cancer drug development -- Targeting mutations in breast cancer -- Targeting the microenvironment in multiple myeloma -- Functional imaging -- New endpoints -- Modeling. Process modeling the drug development pathway -- Dosage modeling -- Modeling benefits and risks -- Development and use of biomarkers in cancer clinical trials -- Innovative clinical trial designs -- Adaptive designs -- Seamless (continuous) clinical trial designs -- Master protocols -- Clinical trials with common control arms -- Issues to consider with innovative clinical trial designs -- Leveraging real-world evidence from clinical practice -- Pragmatic trials -- Using EHR data in studies -- When to use real-world evidence -- Standardization -- Guidance on standardizing and using real-world evidence -- Patient privacy -- Expanding clinical trial eligibility -- Collaboration -- Potential policy opportunities. Innovations at CMS -- FDA oncology center of excellence -- Expanded access -- Cancer moonshot -- Examples of innovations in cancer drug development -- Development of crizotinib -- Development of avelumab -- Development of pembrolizumab -- Development of vemurafenib -- T790M EGFR inhibitors -- Workshop wrap-up -- References -- Appendices. Statement of task. Workshop agenda.
650 0 $aClinical trials$zUnited States$vCongresses.
650 0 $aDrug development$zUnited States$vCongresses.
650 0 $aDevelopmental pharmacology$zUnited States.
650 7 $aClinical trials.$2fast$0(OCoLC)fst00864429
650 7 $aDevelopmental pharmacology.$2fast$0(OCoLC)fst00891814
650 7 $aDrug development.$2fast$0(OCoLC)fst00898670
651 7 $aUnited States.$2fast$0(OCoLC)fst01204155
655 7 $aConference papers and proceedings.$2fast$0(OCoLC)fst01423772
700 1 $aGee, Amanda Wagner,$erapporteur.
700 1 $aBalogh, Erin,$erapporteur.
700 1 $aPatlak, Margie,$erapporteur.
700 1 $aNass, Sharyl J.,$erapporteur.
710 2 $aNational Academies of Sciences, Engineering, and Medicine (U.S.).$bNational Cancer Policy Forum,$eissuing body.
710 2 $aNational Academies of Sciences, Engineering, and Medicine (U.S.).$bBoard on Health Care Services,$eissuing body.
710 2 $aNational Academies of Sciences, Engineering, and Medicine (U.S.).$bHealth and Medicine Division,$eissuing body.
776 08 $iOnline version :$tDrug development paradigm in oncology : proceedings of a workshop.$dWashington, D.C. : National Academies Press, [2018]$w(OCoLC)1000428523
852 00 $boff,sci$hRM301.27$i.D78 2018g