By Karl E. Peace
Utilizing time-to-event research technique calls for cautious definition of the development, censored remark, provision of enough follow-up, variety of occasions, and independence or "noninformativeness" of the censoring mechanisms relative to the development. layout and research of scientific Trials with Time-to-Event Endpoints offers an intensive presentation of the layout, tracking, research, and interpretation of scientific trials during which time-to-event is of serious interest.
After reviewing time-to-event endpoint technique, scientific trial matters, and the layout and tracking of scientific trials, the publication specializes in inferential research tools, together with parametric, semiparametric, express, and Bayesian equipment; a substitute for the Cox version for small samples; and estimation and trying out for swap in threat. It then provides descriptive and graphical tools invaluable within the research of time-to-event endpoints. the following a number of chapters discover numerous medical trials, from analgesic, antibiotic, and antiviral trials to cardiovascular and melanoma prevention, prostate melanoma, astrocytoma mind tumor, and protracted myelogonous leukemia trials. The e-book then covers parts of drug improvement, clinical perform, and protection review. It concludes with the layout and research of medical trials of animals required via the FDA for brand new drug applications.
Drawing at the specialist members’ studies operating in biomedical learn and scientific drug improvement, this complete source covers an array of time-to-event equipment and explores an collection of real-world functions.
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Extra resources for Design and Analysis of Clinical Trials with Time-to-Event Endpoints
2 Phase II Studies (with Time-to-Event Endpoints—PFS or OS) Some phase II studies are beginning to be done with PFS endpoints, rather than tumor response endpoints, for reasons given below. Occasionally, for diseases with very short median OS, or where PFS cannot be reliably measured, OS is the endpoint. Such trials can be one-armed studies, with PFS or OS, measured at a ß 2008 by Taylor & Francis Group, LLC. particular time point, compared to that of historical controls, or they can be randomized studies, utilizing the logrank test.
Finally, a positive phase II result based on PFS is less likely to complicate randomization to the deﬁnitive phase III study than a positive phase II result based on OS. There are also signiﬁcant disadvantages to using PFS as the primary endpoint. Sometimes PFS is difﬁcult to measure reliably. There may also be concern that evaluation of the endpoint is inﬂuenced by investigator treatment bias. Even if the determination of progression is unbiased, bias can arise from differential follow-up by treatment.
Annals of the Institute of Statistical Mathematics, 45: 331–340. ß 2008 by Taylor & Francis Group, LLC.  Pocock SJ, Clayton TC, and Altman DG (2002): Survival plots of time-toevent outcomes in clinical trials: Good practice and pitfalls. The Lancet, 359: 1686–1689.  Prentice RL (1989): Surrogate endpoints in clinical trials: Deﬁnition and operational criteria. Statistics in Medicine, 8: 431–440.  Lin DY, Fleming TR, and De Gruttola V (1997): Estimating the proportion of treatment effect explained by a surrogate marker.
Design and Analysis of Clinical Trials with Time-to-Event Endpoints by Karl E. Peace