NCPA - National Center for Policy Analysis

Clinical Trials Lack Patients

May 13, 1999

Clinical trials are important in developing new treatments for diseases; but the clinical trials required by the Food & Drug Administration are randomized tests involving hundreds or thousands of patients at several hospitals and typically last three to five years. These trials are a bottleneck, and may delay the availability of new treatments for years, says Francine Russo in Atlantic Monthly.

One reason for the delay is the lack of patient participation, particularly in trials for treatment of life-threatening diseases such as cancer.

  • More than a million Americans will be diagnosed with cancer this year, but fewer than three percent of adult cancer patients in the United States are part of a clinical trial.
  • By contrast, 95 percent of children with cancer in the U.S. were enrolled in studies in the 1970s and 1980s and 75 percent of cancers in children are now curable.
  • Some trials have been abandoned for lack of patients, and some groups, such as the elderly and ethnic minorities, are seriously underrepresented.

Trials have already led to major advances in the treatment of melanoma, and cancers of the breast, cervix, uterus, prostate and bladder. But for various reasons, most patients aren't given an opportunity to participate.

  • In fact, 80 percent of patients are enrolled by just 10 percent of doctors.
  • Insurers, including Medicare, have often refused to reimburse for care in a trial even when the patient would receive identical treatment outside the trial.

However, the National Cancer Institute hopes to enroll 10 percent to 15 percent of cancer patients in trials by 2003. And in February, the American Association of Health Plans agreed to encourage managed care organizations to pay the routine care costs for patients in NIH sponsored trials.

Source: Francine Russo, "The Clinical-Trials Bottleneck," Atlantic Monthly, May 1999.


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