Surrogate Markers for Time-Varying Treatments and Outcomes

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dc.contributor.authorHsu, Jesse Y
dc.contributor.authorKennedy, Edward H
dc.contributor.authorRoy, Jason A
dc.contributor.authorStephens-Shields, Alisa J
dc.contributor.authorSmall, Dylan S
dc.contributor.authorJoffe, Marshall M
dc.date2023-05-17T20:23:16.000
dc.date.accessioned2023-05-23T03:38:17Z
dc.date.available2023-05-23T03:38:17Z
dc.date.issued2015-08-01
dc.date.submitted2018-07-13T12:04:43-07:00
dc.description.abstractBACKGROUND: A surrogate marker is a variable commonly used in clinical trials to guide treatment decisions when the outcome of ultimate interest is not available. A good surrogate marker is one where the treatment effect on the surrogate is a strong predictor of the effect of treatment on the outcome. We review the situation when there is one treatment delivered at baseline, one surrogate measured at one later time point, and one ultimate outcome of interest and discuss new issues arising when variables are time-varying. METHODS: Most of the literature on surrogate markers has only considered simple settings with one treatment, one surrogate, and one outcome of interest at a fixed time point. However, more complicated time-varying settings are common in practice. In this article, we describe the unique challenges in two settings, time-varying treatments and time-varying surrogates, while relating the ideas back to the causal-effects and causal-association paradigms. CONCLUSION: In addition to discussing and extending popular notions of surrogacy to time-varying settings, we give examples illustrating that one can be misled by not taking into account time-varying information about the surrogate or treatment. We hope this article has provided some motivation for future work on estimation and inference in such settings.
dc.identifier.urihttps://repository.upenn.edu/handle/20.500.14332/48050
dc.legacy.articleid1628
dc.legacy.fields10.1177/1740774515583500
dc.legacy.fulltexturlhttps://repository.upenn.edu/cgi/viewcontent.cgi?article=1628&context=statistics_papers&unstamped=1
dc.rights<p>Hsu, J.Y., Kennedy, E.H., Roy, J.A., Stephens-Shield, A.J., Small, D.S., & Joffe, M.M., Surrogate Markers for Time-Varying Treatments and Outcomes, Clinical Trials 12, no. 4: pp. 309-316. Copyright © 2015 Society for Clinical Trials. Reprinted by permission of SAGE Publications.</p>
dc.source.beginpage309
dc.source.endpage316
dc.source.issue641
dc.source.issue4
dc.source.journalStatistics Papers
dc.source.journaltitleClinical Trials
dc.source.peerreviewedtrue
dc.source.statuspublished
dc.source.volume12
dc.subject.otherBiomarkers
dc.subject.otherClinical Trials as Topic
dc.subject.otherHumans
dc.subject.otherMathematical Concepts
dc.subject.otherOutcome Assessment (Health Care)
dc.subject.otherRegression Analysis
dc.subject.otherTherapeutics
dc.subject.otherTime Factors
dc.subject.othercausal inference
dc.subject.otherobservational studies
dc.subject.otherrandomization
dc.subject.othersurrogacy
dc.subject.othertime-varying
dc.subject.otherBusiness
dc.subject.otherBusiness Analytics
dc.subject.otherHealth Services Research
dc.subject.otherStatistics and Probability
dc.titleSurrogate Markers for Time-Varying Treatments and Outcomes
dc.typeReport
digcom.contributor.authorHsu, Jesse Y
digcom.contributor.authorKennedy, Edward H
digcom.contributor.authorRoy, Jason A
digcom.contributor.authorStephens-Shields, Alisa J
digcom.contributor.authorSmall, Dylan S
digcom.contributor.authorJoffe, Marshall M
digcom.identifierstatistics_papers/641
digcom.identifier.contextkey12485208
digcom.identifier.submissionpathstatistics_papers/641
digcom.typereport
dspace.entity.typePublication
upenn.schoolDepartmentCenterStatistics Papers
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