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Article: Fractional design: An alternative paradigm for late-onset toxicities in oncology dose-finding studies
Title | Fractional design: An alternative paradigm for late-onset toxicities in oncology dose-finding studies |
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Authors | |
Keywords | Bayesian design Continual reassessment method Dose finding Late-onset toxicityPhase I clinical Trial Time-to-event data |
Issue Date | 2020 |
Publisher | Elsevier: Creative Commons Licenses. The Journal's web site is located at https://journals.elsevier.com/contemporary-clinical-trials-communications/ |
Citation | Contemporary Clinical Trials Communications, 2020, v. 19, p. article no. 100650 How to Cite? |
Abstract | Late-onset (LO) toxicities often arise in the new era of phase I oncology dose-finding trials with targeted agents or immunotherapies. The current LO toxicities modelling is often formulated in a weighted likelihood framework, where the time-to-event continual reassessment method (TITE-CRM) is commonly used. The TITE-CRM uses the patient exposure time as a weight for the censored observation, while there is large uncertainty on which weight function to be used. As an alternative, the fractional scheme formulates an efficient and robust paradigm to address LO toxicity issues in dose finding. We review the fractional continual reassessment method (fCRM) and compare its operating characteristics with those of the TITE-CRM as well as other competitive designs via extensive simulation studies based on both the fixed and randomly generated scenarios. The fCRM is shown to possess desirable operating characteristics in identifying the maximum tolerated dose (MTD) and deliver competitive performances in comparison with other designs. It provides an alternative efficient and robust paradigm for interpreting and addressing LO toxicities in the new era of phase I dose-finding trials in precision oncology. A real trial example is used to illustrate the practical use of the fCRM design. |
Persistent Identifier | http://hdl.handle.net/10722/287725 |
ISSN | 2023 Impact Factor: 1.4 2023 SCImago Journal Rankings: 0.636 |
PubMed Central ID | |
ISI Accession Number ID |
DC Field | Value | Language |
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dc.contributor.author | Yin, G | - |
dc.contributor.author | YANG, Z | - |
dc.date.accessioned | 2020-10-05T12:02:21Z | - |
dc.date.available | 2020-10-05T12:02:21Z | - |
dc.date.issued | 2020 | - |
dc.identifier.citation | Contemporary Clinical Trials Communications, 2020, v. 19, p. article no. 100650 | - |
dc.identifier.issn | 2451-8654 | - |
dc.identifier.uri | http://hdl.handle.net/10722/287725 | - |
dc.description.abstract | Late-onset (LO) toxicities often arise in the new era of phase I oncology dose-finding trials with targeted agents or immunotherapies. The current LO toxicities modelling is often formulated in a weighted likelihood framework, where the time-to-event continual reassessment method (TITE-CRM) is commonly used. The TITE-CRM uses the patient exposure time as a weight for the censored observation, while there is large uncertainty on which weight function to be used. As an alternative, the fractional scheme formulates an efficient and robust paradigm to address LO toxicity issues in dose finding. We review the fractional continual reassessment method (fCRM) and compare its operating characteristics with those of the TITE-CRM as well as other competitive designs via extensive simulation studies based on both the fixed and randomly generated scenarios. The fCRM is shown to possess desirable operating characteristics in identifying the maximum tolerated dose (MTD) and deliver competitive performances in comparison with other designs. It provides an alternative efficient and robust paradigm for interpreting and addressing LO toxicities in the new era of phase I dose-finding trials in precision oncology. A real trial example is used to illustrate the practical use of the fCRM design. | - |
dc.language | eng | - |
dc.publisher | Elsevier: Creative Commons Licenses. The Journal's web site is located at https://journals.elsevier.com/contemporary-clinical-trials-communications/ | - |
dc.relation.ispartof | Contemporary Clinical Trials Communications | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.subject | Bayesian design | - |
dc.subject | Continual reassessment method | - |
dc.subject | Dose finding | - |
dc.subject | Late-onset toxicityPhase I clinical Trial | - |
dc.subject | Time-to-event data | - |
dc.title | Fractional design: An alternative paradigm for late-onset toxicities in oncology dose-finding studies | - |
dc.type | Article | - |
dc.identifier.email | Yin, G: gyin@hku.hk | - |
dc.identifier.authority | Yin, G=rp00831 | - |
dc.description.nature | published_or_final_version | - |
dc.identifier.doi | 10.1016/j.conctc.2020.100650 | - |
dc.identifier.pmid | 32875142 | - |
dc.identifier.pmcid | PMC7451759 | - |
dc.identifier.scopus | eid_2-s2.0-85089525108 | - |
dc.identifier.hkuros | 315624 | - |
dc.identifier.volume | 19 | - |
dc.identifier.spage | article no. 100650 | - |
dc.identifier.epage | article no. 100650 | - |
dc.identifier.isi | WOS:000594377800004 | - |
dc.publisher.place | United States | - |
dc.identifier.issnl | 2451-8654 | - |