Crossover designs for two-treatment clinical trials

2000 ◽  
Vol 87 (1) ◽  
pp. 125-134 ◽  
Author(s):  
K.C. Carriere ◽  
Rong Huang
Author(s):  
Jigneshkumar Gondaliya ◽  
Jyoti Divecha

Abstract Crossover designs robust to changes in carryover models are useful in clinical trials where the nature of carryover effects is not known in advance. The designs have been characterized for being optimal and efficient under no carryover-, traditional-, and, self and mixed carryover- models, however, ignoring the number of subjects, which has significant impact on both optimality and administrative convenience. In this article, adding two more practical models, the traditional, and, self and mixed carryover models having carryover effect only for the new or test treatment, a 5M algorithm is presented. The 5M algorithm based computer code searches all possible two treatment crossover designs under the five carryover models and list those which are optimal and /or efficient to all the five carryover models. The resultant exhaustive list consists of optimal and/or efficient crossover designs in two, three, and four periods, having 4 to 20 subjects of which 24 designs are new optimal for one of the established carryover models, and 34 designs are optimal for newly added models.


CNS Spectrums ◽  
2004 ◽  
Vol 9 (1) ◽  
pp. 49-56 ◽  
Author(s):  
Eric Hollander ◽  
Ann Phillips ◽  
Bryan H. King ◽  
Donald Guthrie ◽  
Michael G. Aman ◽  
...  

ABSTRACTThere are specific challenges to studying the design of pharmacologic trials in child/adolescent and adult autism, such as subject stratification and parallel versus crossover designs. This article describes how optimal study design is influenced by subject selection and outcome measures chosen. Lessons learned in study design from the Research Units on Pediatric Psychopharmacology Autism Network trial with risperidone, Seaver Center trials with fluoxetine and valproate, Dartmouth trials with amantadine, and National Institutes of Health secretin trials are highlighted. The Internet System for Assessing Autistic Children system for managing multicenter clinical trials in autism and statistical issues in autism research are also described.


1991 ◽  
Vol 12 (5) ◽  
pp. 694
Author(s):  
Tom G. Filloon ◽  
Michael P. Meredith

2002 ◽  
Vol 11 (2) ◽  
pp. 111-123 ◽  
Author(s):  
Alan Feingold ◽  
Alison Oliveto ◽  
Richard Schottenfeld ◽  
Thomas R. Kosten

1994 ◽  
Vol 13 (10) ◽  
pp. 1063-1069 ◽  
Author(s):  
K. C. Carriere

2021 ◽  
Author(s):  
Dan-Yu Lin ◽  
Donglin Zeng ◽  
Peter B. Gilbert

AbstractLarge-scale deployment of safe and durably effective vaccines can halt the COVID-19 pandemic.1–3 However, the high vaccine efficacy reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months4–5 and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross placebo recipients to the vaccine arm according to priority groups. Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of placebo recipients. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.SummaryWe show how to estimate potentially waning long-term efficacy of COVID-19 vaccines in randomized, placebo-controlled clinical trials with staggered enrollment of participants and sequential crossover of placebo recipients.


Author(s):  
D. C. Swartzendruber ◽  
Norma L. Idoyaga-Vargas

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.


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