Biostatistical Design and Analyses of Long-Term Animal Studies Simulating Human Postmenopausal Osteoporosis

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Hothorn, L.A.; Bauss, F.: Biostatistical Design and Analyses of Long-Term Animal Studies Simulating Human Postmenopausal Osteoporosis. In: Therapeutic Innovation & Regulatory Science 38 (2004), Nr. 1, S. 47-56. DOI:

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Sum total of downloads: 72

Using three well-designed experimental studies as illustration, we demonstrate that the biostatistical design and analysis of long-term animal studies simulating human osteoporosis should be analogous to the design and analysis of randomized clinical trials. This principal is in accordance with the recommendations from the International Conference on Harmonisation guidelines concerning statistical principles in clinical trials (1). An important element of biostatistical study design is sample size. The three studies that are described herein used an a-priori sample size estimation for the one-way layout that included controls and several treatment and dose groups. In these k-sample designs, with at least one control group, both the multiple comparison procedure and trend tests within procedures for identification of the minimal-effective dose are recommended. Although p-values in pharmacology are quite common, confidence intervals should be used according to their interpretation for both statistical significance and clinical relevance. The use of one-sided confidence intervals for both the difference and the ratio to control for proving either superiority or at least noninferiority is demonstrated by real data examples. Relevant and relatively straightforward software is available for biostatistical analysis and can also be used to aid design. In summary, referring to published, well-designed experimental studies can help to assist with ensuring the quality of future investigations. © 2004, Drug Information Association. All rights reserved.
License of this version: Es gilt deutsches Urheberrecht. Das Dokument darf zum eigenen Gebrauch kostenfrei genutzt, aber nicht im Internet bereitgestellt oder an Außenstehende weitergegeben werden. Dieser Beitrag ist aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
Document Type: article
Publishing status: publishedVersion
Issue Date: 2004
Appears in Collections:Naturwissenschaftliche Fakultät

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1 image of flag of Germany Germany 62 86.11%
2 image of flag of Romania Romania 2 2.78%
3 image of flag of Canada Canada 2 2.78%
4 image of flag of No geo information available No geo information available 1 1.39%
5 image of flag of United States United States 1 1.39%
6 image of flag of Korea, Republic of Korea, Republic of 1 1.39%
7 image of flag of United Kingdom United Kingdom 1 1.39%
8 image of flag of Czech Republic Czech Republic 1 1.39%
9 image of flag of Brazil Brazil 1 1.39%

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