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Alternatives to randomized clinical trials.

G W Ellison1, M R Mickey, L W Myers

  • 1Department of Neurology, UCLA School of Medicine.

Neurology
|July 1, 1988
PubMed
Summary
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Using historical controls from patient databases in multiple sclerosis trials can be misleading. New treatments may appear more effective than they are, so claims require scrutiny, especially in later-phase trials.

Area of Science:

  • Clinical trials methodology
  • Multiple sclerosis research
  • Biostatistics

Background:

  • Historical controls from patient databases are proposed for multiple sclerosis (MS) clinical trials.
  • These controls may include natural history data or placebo-treated patient courses.
  • Potential biases associated with historical controls require careful consideration.

Purpose of the Study:

  • To evaluate the reliability of using historical controls in clinical therapeutic trials for multiple sclerosis.
  • To assess the potential for misleading efficacy findings when using historical controls.
  • To determine the appropriate phase of clinical trials for utilizing historical control groups.

Main Methods:

  • Review of existing literature on clinical trial design and control groups.

Related Experiment Videos

  • Analysis of potential biases introduced by historical control data.
  • Comparison of historical controls with concurrent controls in therapeutic trials.

    • Main Results:

    • Trials using historical controls show a strong tendency to overestimate treatment efficacy.
    • Efficacy claims derived from historical control comparisons should be critically examined.
    • Historical controls may lead to misleading results, particularly in definitive phase III trials.

    Conclusions:

    • Historical controls in multiple sclerosis trials can produce misleading results.
    • Claims of efficacy based on historical controls warrant close scrutiny.
    • Historical controls are best suited for preliminary and early phase II pilot trials, not definitive phase III trials.