Observational Research

The Nonexperimental Approach
  • Rosanne B. McTyre
  • Linda M. Pottern


The randomized controlled clinical trial, or experimental approach, is considered to be the “gold standard” for the evaluation of medical device safety and effectiveness, and constitutes the basis of the approval process for many medical devices. 1 One of the most important reasons why this method is preferred is that, through the randomization process, it is more likely to lead to an unbiased interpretation of results than other types of study designs, as described in Chapter 1. It should be recognized, however, that there are situations in which the experimental approach is either not feasible because of cost or practical limitations (e.g., a rare disease), or unethical as in circumstances where no alternative therapy exists. Occasionally, nonrandomized concurrent controlled trials or even observational studies based on sound historical data may be considered valid alternatives in the evaluation of devices. 2


Medical Device National Health Interview Survey Observational Research Artificial Disk Silicone Breast Implant 
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  1. 1.
    Food and Drug Administration, Health and Human Services. 1994. Determination of Safety and Effectiveness. 21 CFR §860.7.Google Scholar
  2. 2.
    Sapirstein, W., Alpert, S., and Callahan, T. J. 1994. The role of clinical trials in the Food and Drug Administration approval process for cardiovascular devices. Circulation 89: 1900–1902.CrossRefGoogle Scholar
  3. 3.
    Lilienfeld, D. E. and Stolley, P. D. 1994. Foundations of Epidemiology. 3rd ed. Oxford University Press, Oxford.Google Scholar
  4. 4.
    Griffith, S. L., Shelokov, A. P., Buttner-Janz, K., LeMaire, J.-P., and Zeegers, W. S. 1994. A multicenter retrospective study of the clinical results of the LINK® SB Charité intervertebral prosthesis. The initial European experience. Spine 19: 1842–1849.CrossRefGoogle Scholar
  5. 5.
    Thompson, W. D. 1994. Statistical analysis of case-control studies. Epidemiol. Rev. 16: 33–50.Google Scholar
  6. 6.
    Hochberg, M. C., Perlmutter, D. L., White, B., Steen, V., Medsger, T. A., Weisman, M., and Wigley, F. M. 1994. The association of augmentation mammoplasty with systemic sclerosis: results from a multicenter case-control study. Abstract presented at 58th Annual Meeting of the American College of Rheumatology, October 23–27, Minneapolis, MN.Google Scholar
  7. 7.
    MacMahon, B. and Pugh, T. F. 1970. Epidemiology Principles and Methods. Little, Brown, Boston.Google Scholar
  8. 8.
    Sanchez-Guerrero, J., Colditz, G. A., Karlson, E. W., Hunter, D. J., Speizer, F. E., and Liang, M. H. 1994. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N. Engl. J. Med. 332:1666–1670.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 1998

Authors and Affiliations

  • Rosanne B. McTyre
  • Linda M. Pottern

There are no affiliations available

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