Controlled Clinical Trials in Neurological Disease

1. Front Matter

   Pages i-xxiii

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2. Design of Controlled Clinical Trials

   1. Front Matter

      Pages 1-1

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   2. Clinical Considerations

      • John F. Kurtzke

      Pages 3-16

   3. Initial Statistical Considerations

      • B. G. White

      Pages 17-27

   4. Statistical and Epidemiological Considerations

      • James M. Dambrosia

      Pages 29-51

3. Implementation and Interpretations of Controlled Clinical Trials (Example: Epilepsy)

   1. Front Matter

      Pages 53-53

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   2. Perspective of the Patient

      • Nancy Santilli

      Pages 55-62

   3. Perspective of the Participating Investigator

      • Fritz E. Dreifuss, Nancy Santilli

      Pages 63-68

   4. Perspective of the Clinical Center

      • Nancy Santilli

      Pages 69-76

   5. Perspective of the Coordinating Center

      • James J. Cereghino

      Pages 77-83

   6. Perspective of the Food and Drug Administration

      • Russell Katz

      Pages 85-96

   7. Perspective of the Pharmaceutical Industry

      • Lynn D. Kramer, James L. Perhach

      Pages 97-104

   8. Perspective of the Insurance Industry

      • Lawrence C. Morris

      Pages 105-110

4. Applications of Controlled Clinical Trials to Diseases of the Nervous System

   1. Front Matter

      Pages 111-111

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   2. Cerebrovascular Disease

      • Michel A. Beaudry, Vladimir C. Hachinski

      Pages 113-132

   3. Epilepsy

      • Roger J. Porter

      Pages 133-155

   4. Movement Disorders

      • Lawrence I. Golbe, Roger C. Duvoisin

      Pages 157-170

   5. Head and Spinal Cord Injury

      • Howard M. Eisenberg

      Pages 171-183

   6. Headache

      • Jes Olesen, Peer Tfelt-Hansen

      Pages 185-201

   7. Peripheral Neuropathy

      • Peter James Dyck, Peter O’brien

      Pages 203-224

The evaluation of the efficacy and safety of a clinical tool, be it a diagnostic technique, a preventive methodology, or a therapeutic intervention, is an im­ portant responsibility of physicians. The history of medicine is characterized by the authoritarianisms of teachers and of organizations giving way to the clinical experience of physicians; authoritarian dictum was replaced by case report and then by case series. As physicians learned to substitute the analysis of data for the inconsistencies of dictums and anecdotes, the problems of the case series as an investigative tool became more evident: patient selection criteria, measurements of outcome, significance of results, and extrapolation of conclusions to the community of patients. In response to these issues, the methodology of the controlled clinical trial has evolved and with it the instru­ ments of study design and of biostatistics as aids to study design and data analysis. The medical - surgical armamentarium has evolved from being dependent solely upon the observations and conclusions of a skilled clinician to being constructed upon the systematic collection and evaluation of data by a team of skilled clinicians and their statistical colleagues: this is the controlled clinical trial. During the past two decades, the evaluation of clinical approaches to pre­ vention and therapy has become particularly important to clinicians concerned with nervous system dysfunction. There has been and continues to be an explosion of information from the basic neurosciences and from the applica­ tion of biotechnology to the nervous system.

• Alzheimer
• Nervous System
• alzheimer's disease
• brain
• brain tumor
• neuroscience
• spinal cord
• tumor

`Cet ouvrage, rédigée par de nombreux experts et d'une manière fort critique, est certainement très précieux. Il mérite d'être lu et médité.'
Acta Neurologica, 90, 1990

` ... for any serious researcher. The book is recommended for all health care professionals who have an interest in neurological neurosurgical or neurorehabilitative research.'
Brain Injury, 7:1

• National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, USA

  Roger J. Porter, Bruce S. Schoenberg

Policies and ethics