Abstract
Over the past decades the randomized clinical trial has entered an era of continuous improvement and has gradually become accepted as the most effective way of determining the relative efficacy and toxicity of new drug therapies. This book is mainly involved in the methods of prospective randomized clinical trials of new drugs. Other methods for assessment including open-evaluation-studies, cohort- and case-control studies, although sometimes used, e.g., for pilot studies and for the evaluation of long term drug-effects, are, however, not excluded in this course. Traditionally, clinical drug trials are divided into IV phases (from phase I for initial testing to phase IV after release for general use), but scientific rules governing different phases are very much the same, and can thus be discussed simultaneously.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Freirich F (1983) Ethical problem of allowing a random event to determine a patient’s treatment. In: Controversies in clinical trials. Philadelphia, Saunders, p 5
Graham WG, Bradley DA (1978) Efficacy of chest physiotherapy and intermittent positive-pressure breathing in the resolution of pneumonia. N Engl J Med 299:624–627
Kallis F et al (1994) Aspirin versus placebo before coronary artery surgery. Eur J Cardiovasc Surg 8:404–410
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2012 Springer Science+Business Media B.V.
About this chapter
Cite this chapter
Cleophas, T.J., Zwinderman, A.H. (2012). Hypotheses, Data, Stratification. In: Statistics Applied to Clinical Studies. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-2863-9_1
Download citation
DOI: https://doi.org/10.1007/978-94-007-2863-9_1
Published:
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-007-2862-2
Online ISBN: 978-94-007-2863-9
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)