000182282 001__ 182282
000182282 005__ 20241220120852.0
000182282 0247_ $$2doi$$a10.1002/pst.2268
000182282 0247_ $$2pmid$$apmid:36285348
000182282 0247_ $$2ISSN$$a1539-1604
000182282 0247_ $$2ISSN$$a1539-1612
000182282 0247_ $$2altmetric$$aaltmetric:138016756
000182282 037__ $$aDKFZ-2022-02542
000182282 041__ $$aEnglish
000182282 082__ $$a610
000182282 1001_ $$0P:(DE-He78)288ea89dbbad8b91534dfb0ef4dcb02d$$aLabrenz, Jannik$$b0
000182282 245__ $$aPerformance of phase-I dose finding designs with and without a run-in intra-patient dose escalation stage.
000182282 260__ $$aNew York, NY$$bWiley$$c2023
000182282 3367_ $$2DRIVER$$aarticle
000182282 3367_ $$2DataCite$$aOutput Types/Journal article
000182282 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1678877537_29493
000182282 3367_ $$2BibTeX$$aARTICLE
000182282 3367_ $$2ORCID$$aJOURNAL_ARTICLE
000182282 3367_ $$00$$2EndNote$$aJournal Article
000182282 500__ $$a#LA:C060#LA:W010# / 2023 Mar;22(2):236-247
000182282 520__ $$aDose-finding designs for phase-I trials aim to determine the recommended phase-II dose (RP2D) for further phase-II drug development. If the trial includes patients for whom several lines of standard therapy failed or if the toxicity of the investigated agent does not necessarily increase with dose, optimal dose-finding designs should limit the frequency of treatment with suboptimal doses. We propose a two-stage design strategy with a run-in intra-patient dose escalation part followed by a more traditional dose-finding design. We conduct simulation studies to compare the 3 + 3 design, the Bayesian Optimal Interval Design (BOIN) and the Continual Reassessment Method (CRM) with and without intra-patient dose escalation. The endpoints are accuracy, sample size, safety, and therapeutic efficiency. For scenarios where the correct RP2D is the highest dose, inclusion of an intra-patient dose escalation stage generally increases accuracy and therapeutic efficiency. However, for scenarios where the correct RP2D is below the highest dose, intra-patient dose escalation designs lead to increased risk of overdosing and an overestimation of RP2D. The magnitude of the change in operating characteristics after including an intra-patient stage is largest for the 3 + 3 design, decreases for the BOIN and is smallest for the CRM.
000182282 536__ $$0G:(DE-HGF)POF4-313$$a313 - Krebsrisikofaktoren und Prävention (POF4-313)$$cPOF4-313$$fPOF IV$$x0
000182282 588__ $$aDataset connected to CrossRef, PubMed, , Journals: inrepo02.dkfz.de
000182282 650_7 $$2Other$$adose escalation
000182282 650_7 $$2Other$$adose-finding
000182282 650_7 $$2Other$$aintra-patient
000182282 650_7 $$2Other$$amaximum tolerated dose
000182282 650_7 $$2Other$$aphase-I
000182282 7001_ $$0P:(DE-He78)92820b4867c955a04f642707ecf35b40$$aEdelmann, Dominic$$b1
000182282 7001_ $$0P:(DE-He78)647bd2cb06a172c109d3469e8915428d$$aHeitmann, Jonas$$b2
000182282 7001_ $$0P:(DE-He78)15af5d9d6d8f165d5ff4dd165ffecb22$$aSalih, Helmut$$b3
000182282 7001_ $$0P:(DE-He78)bb6a7a70f976eb8df1769944bf913596$$aKopp-Schneider, Annette$$b4$$eLast author
000182282 7001_ $$0P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc$$aSchlenk, Richard$$b5$$eLast author$$udkfz
000182282 773__ $$0PERI:(DE-600)2083706-9$$a10.1002/pst.2268$$gp. pst.2268$$n2$$p236-247$$tPharmaceutical statistics$$v22$$x1539-1604$$y2023
000182282 8767_ $$82022 (V10366)$$92022-06-23$$d2024-12-19$$eHybrid-OA$$jZahlung erfolgt
000182282 909CO $$ooai:inrepo02.dkfz.de:182282$$pVDB$$pOpenAPC$$popenCost
000182282 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)288ea89dbbad8b91534dfb0ef4dcb02d$$aDeutsches Krebsforschungszentrum$$b0$$kDKFZ
000182282 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)92820b4867c955a04f642707ecf35b40$$aDeutsches Krebsforschungszentrum$$b1$$kDKFZ
000182282 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)647bd2cb06a172c109d3469e8915428d$$aDeutsches Krebsforschungszentrum$$b2$$kDKFZ
000182282 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)15af5d9d6d8f165d5ff4dd165ffecb22$$aDeutsches Krebsforschungszentrum$$b3$$kDKFZ
000182282 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)bb6a7a70f976eb8df1769944bf913596$$aDeutsches Krebsforschungszentrum$$b4$$kDKFZ
000182282 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc$$aDeutsches Krebsforschungszentrum$$b5$$kDKFZ
000182282 9131_ $$0G:(DE-HGF)POF4-313$$1G:(DE-HGF)POF4-310$$2G:(DE-HGF)POF4-300$$3G:(DE-HGF)POF4$$4G:(DE-HGF)POF$$aDE-HGF$$bGesundheit$$lKrebsforschung$$vKrebsrisikofaktoren und Prävention$$x0
000182282 9141_ $$y2022
000182282 915__ $$0StatID:(DE-HGF)3001$$2StatID$$aDEAL Wiley$$d2021-01-27$$wger
000182282 915__ $$0StatID:(DE-HGF)0160$$2StatID$$aDBCoverage$$bEssential Science Indicators$$d2021-01-27
000182282 915__ $$0StatID:(DE-HGF)0113$$2StatID$$aWoS$$bScience Citation Index Expanded$$d2021-01-27
000182282 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS$$d2023-10-24
000182282 915__ $$0StatID:(DE-HGF)0300$$2StatID$$aDBCoverage$$bMedline$$d2023-10-24
000182282 915__ $$0StatID:(DE-HGF)0199$$2StatID$$aDBCoverage$$bClarivate Analytics Master Journal List$$d2023-10-24
000182282 915__ $$0StatID:(DE-HGF)0150$$2StatID$$aDBCoverage$$bWeb of Science Core Collection$$d2023-10-24
000182282 915__ $$0StatID:(DE-HGF)1030$$2StatID$$aDBCoverage$$bCurrent Contents - Life Sciences$$d2023-10-24
000182282 915__ $$0StatID:(DE-HGF)0100$$2StatID$$aJCR$$bPHARM STAT : 2022$$d2023-10-24
000182282 915__ $$0StatID:(DE-HGF)0600$$2StatID$$aDBCoverage$$bEbsco Academic Search$$d2023-10-24
000182282 915__ $$0StatID:(DE-HGF)0030$$2StatID$$aPeer Review$$bASC$$d2023-10-24
000182282 915__ $$0StatID:(DE-HGF)9900$$2StatID$$aIF < 5$$d2023-10-24
000182282 915pc $$0PC:(DE-HGF)0000$$2APC$$aAPC keys set
000182282 915pc $$0PC:(DE-HGF)0001$$2APC$$aLocal Funding
000182282 9202_ $$0I:(DE-He78)C060-20160331$$kC060$$lC060 Biostatistik$$x0
000182282 9202_ $$0I:(DE-He78)W010-20160331$$kW010$$lKlinische Studienzentrale$$x1
000182282 9201_ $$0I:(DE-He78)C060-20160331$$kC060$$lC060 Biostatistik$$x0
000182282 9201_ $$0I:(DE-He78)TU01-20160331$$kTU01$$lDKTK TU zentral$$x1
000182282 980__ $$ajournal
000182282 980__ $$aVDB
000182282 980__ $$aI:(DE-He78)C060-20160331
000182282 980__ $$aI:(DE-He78)TU01-20160331
000182282 980__ $$aUNRESTRICTED
000182282 980__ $$aAPC