Extending Medicare Reimbursement in Clinical Trials (2000) / Chapter Skim
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15 1 Clinical Trials in the United States BACKGROUND ON CLINICAL TRIALS A clinical trial is a formal study carried out according to a prospectively defined protocol. It is intended to discover or verify the safety and effectiveness in human beings of interventions to promote well-being, or to prevent, diagnose, or treat illness.
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16 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS diagnostic tests, screening procedures, devices, and other forms of medical advice or patient care. The definition of clinical trial used in this report encompasses some studies involving only a single intervention group.
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CLINICAL TRIALS IN THE UNITED STATES 17 difference in the seed or fertilizer being tested, or due to differences in soil, temperature, moisture, and light? Fisher proposed dividing plots of land into narrow strips and assigning experimental treatments their place in the soil by a chance mechanism.
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18 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS compare two or more "standard" interventions, all of which may be effective to some extent, to find out which works best. Participant Population and Sample Size It is generally accepted that the types and numbers of participants to be sought for a trial must be determined before the trial can begin.
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CLINICAL TRIALS IN THE UNITED STATES 19 Randomization and Blinding It is widely accepted that participants must be assigned to intervention groups through randomization, a process that ensures an equal probability of getting any one of the treatments. Variations on the simplest form of the randomization process (a list of random numbers)
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20 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS Analysis The fundamental analysis of a controlled clinical trial is a comparison of the rates of important outcomes among the intervention groups. The difficult part is assuring that differences are due mainly to the different treatments, and not to chance or bias.
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CLINICAL TRIALS IN THE UNITED STATES 21 vulnerable in decisions relating to their health. In addition, they may not understand all the intricacies of the trial or their alternatives.
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22 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS from central policy makers to the physician in the clinic) is to use all the reliable information available to determine the best intervention for a specific condition.
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CLINICAL TRIALS IN THE UNITED STATES 23 dures) do not involve the approval of commercial products and are typically funded by NIH or a medical center where the trial is undertaken.
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24 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS has estimated that about 108,000 individuals enter into NIH-sponsored clinical treatment trials (this excludes trials of disease prevention) each year, with the largest number (an estimated 30,000)
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CLINICAL TRIALS IN THE UNITED STATES 25 FDA does not conduct clinical trials, but it has a major review function. Clinical trials using pharmaceuticals, biologics, or devices not yet approved by FDA always requires that research protocols be filed with FDA.
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26 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS Mayo Clinic (Wagner et al., 1999) Cases were selected from local Minnesota residents who participated in cancer treatment trials at the Mayo Clinic from 1988 through 1994.
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CLINICAL TRIALS IN THE UNITED STATES 27 Conclusions Taken together, these three pilot studies indicate that there may be a modest excess in medical costs for patients enrolled in NCI-sponsored clinical trials, compared with similar patients not enrolled in trials. While these analyses constitute the best data currently available on this question, they were based on small numbers of patients in a few types of cancer treatment trials.
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28 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS Registry of Clinical Trials of Drugs for Serious and Life-Threatening Diseases The Food and Drug Administration Modernization Act of 1997 (P.L.
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CLINICAL TRIALS IN THE UNITED STATES 29 An NIH working group has developed a somewhat longer (though still brief) list of data elements, but the list is not yet final.
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