Practical approaches for design and analysis of clinical trials of infertility treatments: crossover designs and the Mantel-Haenszel method are recommended

2015 ◽  
Vol 14 (3) ◽  
pp. 198-204 ◽  
Author(s):  
Michihiro Takada ◽  
Takashi Sozu ◽  
Tosiya Sato
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

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