Multiple Sclerosis: Study Design, Sample Sizes and Pitfalls
| Autor: | B. G. Weinshenker, J. H. Noseworthy |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Oncology
medicine.medical_specialty Expanded Disability Status Scale biology medicine.drug_class business.industry Multiple sclerosis medicine.medical_treatment T cell Transforming growth factor beta medicine.disease Monoclonal antibody Clinical trial Cytokine medicine.anatomical_structure Internal medicine medicine biology.protein Glatiramer acetate business medicine.drug |
| Zdroj: | Clinical Trials in Neurology ISBN: 9781849968560 |
| Popis: | Rapid growth in the number, scale and quality of clinical trials in multiple sclerosis (MS) has occurred over the last decade. The recent surge of interest has resulted from a number of developments. Firstly, basic scientific inquiry in such areas as cytokine research, T cell receptor gene recombination and adhesion molecule interactions has suggested novel methods of treatment, including the use of immunoregulatory cytokines (e.g. interferon beta, transforming growth factor beta), T cell or T cell receptor peptide vaccination, and monoclonal antibodies to adhesion cell antigens expressed on the surface of lymphocytes and endothelial cells so as to block their interaction [1]. Secondly, a certain degree of optimism has developed following the report of positive results in three phase III trials of therapeutic agents [2–4], which have now been demonstrated to reduce attacks. One agent, interferon beta-la (Avonex), reduced short-term progression of neurological impairment as determined by change in terms of the Expanded Disability Status Scale (EDSS). Finally, rapid advances in magnetic resonance (MR) technology have provided a sensitive, objective, quantitative, and easily blind method for detecting treatment effects in phase I and II trials in a fraction of the time necessary for a definitive phase III clinical trial. MR technology has been proposed and widely accepted to be the primary outcome of choice for screening potential therapeutic agents for efficacy in phase I and II clinical trials [5]. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|