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Controlled Clinical Trials in Tuberculosis: Lessons to Be Drawn

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Book cover Mycobacteria

Part of the book series: Chapman & Hall Medical Microbiology Series ((CHMMS))

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Abstract

Any drug combination has to be assessed ultimately in humans, irrespective of how successful it is in the test tube or in experimental animals. In other words, it must be subjected to a clinical trial of some sort. Only rarely does the investigator have in his possession a wonder drug such as a penicillin or an insulin, the effiicacy of which is so obvious that it needs little rigorous investigation. More often than not, he is in the position of having to determine whether a new drug or regimen is indeed better (i.e., has greater efficacy or produces fewer side effects) than the standard, and the magnitude of the expected difference is not dramatically large. It is such situations that the randomized controlled trial (RCT) is designed to meet. One of the earliest, and still perhaps the most lucid, expositions of the controlled clinical trial was made by Bradford Hill (1). The ingredients of a good clinical trial include the following: a detailed description of the treatment regimen (drugs, dosage, rhythm, duration); a clear statement of the objectives (e.g., efficacy, toxicity, acceptability), together with the order of priorities; precise specification of the type of patients to be admitted (i.e., eligibility criteria, contraindications); the use of concurrent controls obtained by a process of random allocation; explicitly described procedures for ensuring similarity in the subsequent management of patients in the different treatment groups; and objective evaluation of the outcome measures, supported by tests of statistical significance.

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Authors
  1. S. Radhakrishna
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Editors and Affiliations

  1. Chicago College of Medicine, University of Illinois, Chicago, Illinois, USA

    Pattisapu R. J. Gangadharam Ph.D. (Professor of Medicine, Microbiology, and Pathology, Director of Mycobacteriology Research) (Professor of Medicine, Microbiology, and Pathology, Director of Mycobacteriology Research)

  2. Public Health Laboratory Service, University Hospital of Wales, UK

    P. Anthony Jenkins Ph.D. (Director) (Director)

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Radhakrishna, S. (1998). Controlled Clinical Trials in Tuberculosis: Lessons to Be Drawn. In: Gangadharam, P.R.J., Jenkins, P.A. (eds) Mycobacteria. Chapman & Hall Medical Microbiology Series. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-7511-5_4

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  • DOI: https://doi.org/10.1007/978-1-4615-7511-5_4

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4615-7513-9

  • Online ISBN: 978-1-4615-7511-5

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