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

Author:

Takada Michihiro1,Sozu Takashi2,Sato Tosiya2

Affiliation:

1. Ajinomoto Pharmaceutical CO., Ltd., 1-1; Irifune2-chome; Chuo-ku Tokyo 104-0042 Japan

2. Department of Biostatistics, School of Public Health; Kyoto University; Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference16 articles.

1. Crossover or parallel design in infertility trials? The discussion continues;Cohlen;Fertility and Sterility,1998

2. The alternating-sequence design (or multiple-period crossover) trial for evaluating treatment efficacy in infertility;Norman;Fertility and Sterility,2000

3. Cross‐over Trials In Clinical Research

4. Current thoughts on cross-over designs;Dubey;Clinical Research and Regulatory Affairs,1986

5. Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff. Design Considerations for Pivotal Clinical Investigations for Medical Devices Rockville, MD 2013

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