000294420 001__ 294420
000294420 005__ 20241127153259.0
000294420 0247_ $$2doi$$a10.1200/EDBK_278893
000294420 0247_ $$2pmid$$apmid:32207673
000294420 0247_ $$2ISSN$$a1548-8748
000294420 0247_ $$2ISSN$$a1548-8756
000294420 0247_ $$2ISSN$$a1930-7020
000294420 037__ $$aDKFZ-2024-02249
000294420 041__ $$aEnglish
000294420 082__ $$a610
000294420 1001_ $$aReaman, Gregory$$b0
000294420 245__ $$aCrossing Oceans: Preclinical Collaboration to Improve Pediatric Drug Development.
000294420 260__ $$aAlexandria, VA$$bAmerican Society of Clinical Oncology$$c2020
000294420 3367_ $$2DRIVER$$aarticle
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000294420 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1730991084_24895
000294420 3367_ $$2BibTeX$$aARTICLE
000294420 3367_ $$2ORCID$$aJOURNAL_ARTICLE
000294420 3367_ $$00$$2EndNote$$aJournal Article
000294420 520__ $$aChanges in the regulatory environment affecting pediatric cancer drug development in the United States and the European Union provide unprecedented opportunity to advance the concept of precision medicine to children with cancer. Increasing evidence suggests that new drugs and biologic products directed at molecular targets presumed to be etiologically associated with many adult cancers may well provide therapeutic options for selected subsets of children with cancer despite their histologic and biologic differences. Regulatory requirements for early evaluation of appropriate new drugs for children based on their molecular mechanism of action, rather than the specific clinical indications for which they are developed and/or approved, will shorten the unacceptable time lag between first-in-human and first-in-children studies. The relative scarcity of pediatric patients eligible for biomarker-directed studies and the ever-expanding compendium of new targeted agents mandate rational, science-based decision-making in selecting and prioritizing appropriate drugs to study early in development. A critical component of the evidence base in such decision-making includes preclinical testing of relevant drugs in pediatric tumor-specific in vitro and in vivo models. Established preclinical testing programs with academic investigator-industry collaborations are actively engaged in such activities. International collaboration is required to address the resource constraints and increasing number of potential products to be tested in a timely, efficient, nonduplicative, and cost-effective manner.
000294420 588__ $$aDataset connected to CrossRef, PubMed, , Journals: inrepo02.dkfz.de
000294420 650_2 $$2MeSH$$aChild
000294420 650_2 $$2MeSH$$aDrug Development
000294420 650_2 $$2MeSH$$aHumans
000294420 7001_ $$aStancato, Louis$$b1
000294420 7001_ $$aVassal, Gilles$$b2
000294420 7001_ $$aMaris, John M$$b3
000294420 773__ $$0PERI:(DE-600)2431126-1$$a10.1200/EDBK_278893$$gVol. 40, no. 40, p. 409 - 416$$n40$$p409 - 416$$tEducational book / American Society of Clinical Oncology$$v40$$x1548-8748$$y2020
000294420 8564_ $$uhttps://inrepo02.dkfz.de/record/294420/files/et-al-2020-crossing-oceans-preclinical-collaboration-to-improve-pediatric-drug-development.pdf
000294420 8564_ $$uhttps://inrepo02.dkfz.de/record/294420/files/et-al-2020-crossing-oceans-preclinical-collaboration-to-improve-pediatric-drug-development.pdf?subformat=pdfa$$xpdfa
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000294420 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS$$d2023-09-02
000294420 9801_ $$aEXTERN4VITA
000294420 980__ $$ajournal
000294420 980__ $$aEDITORS
000294420 980__ $$aI:(DE-He78)W510-20160331
000294420 980__ $$aI:(DE-He78)W500-20160331