Clinical trials in the elderly. Pivotal points.
A clinical trial, that is, the scientific assessment of drug action in humans, must be undertaken only if there is reference to an expectation of benefit from the trial. Before the trial starts, a series of questions should be answered, including the need for the trial in elderly patients, particularly in view of the possible vulnerability of the elderly study subjects. Patient selection, randomization, follow-up, analysis, and interpretation must be scientifically valid. Of major importance is the external validity of the trial, that is, the generalizability. Any trial, particularly those involving the elderly, should be designed to develop or contribute to generalizable knowledge; that is, it should be possible to extend the conclusions from the trial beyond the study population to the population at large. When elderly are involved, as they should be when a drug is proposed for use mainly in the elderly population, it is especially important that the study be scientifically valid, medically important, and ethically sound. Studies involving the elderly should have sufficient numbers of females and minorities, the former because most elderly patients are females, the latter because minorities now reach the age of 65 years and beyond more so than in the past. Both risk and benefit should be addressed in terms of potential magnitude and duration. If the study drug has a narrow therapeutic window, it should be intensively studied. When the study is completed, there ought to be clear guidelines for the clinician to design initial, individualized, optimal dosage regimens or for subsequent adjustment of the regimen. The final report, which should be easily evaluable by clinicians, should fully discuss reasons for dropouts, inappropriate patient inclusion, number and types of adverse reactions, and defects in design and conduct of the study.
Kitler
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D000368:Aged; D002986:Clinical Trials as Topic; D004358:Drug Therapy; D005853:Geriatrics; D006801:Humans; D010601:Pharmacology, Clinical; D012107:Research Design