You can teach an old dog new tricks: how AIDS trials are pioneering new strategies

Article Abstract:

The traditional ways of evaluating new drugs are changing as a consequence of the AIDS epidemic. Clinical trials usually pass through three phases: phase I, a test of safety; phase II, a test of effectiveness; and phase III, a test that compares the new drug with the standard therapy. Now, under pressure from AIDS patients, all participants in clinical trials for AIDS-related drugs are to have a similar opportunity to receive beneficial treatment. The control group should receive the best possible care, which follows a principle applied to drug testing in cancer patients. Moreover, patients may enter AIDS drug trials even if they have disease complications; no one is to be excluded. Changes are made in study protocols while the research is ongoing, a practice heretofore forbidden under the rules of rigorous experimental design. When lower doses of zidovudine, the drug approved for treating AIDS, than were used in original clinical trials were found effective, the lower dose immediately became the standard for AIDS Clinical Trials Group studies. Patients sometimes cross over into other treatment groups before their own group has completed its protocol. Such developments represent a dramatic departure from traditional methods of drug research. Attempts are made to shorten all three phases of drug testing to benefit as many patients as possible. However, these changes should not be allowed to compromise the scientific quality of the data collected. The Food and Drug Administration also reviews AIDS drugs more rapidly than before, and has speeded up its licensing processes. Since AIDS symptoms occur, on average, 11 years after infection, the appearance of increased numbers of symptomatic patients can be anticipated in the near future. New drugs and new drug administration strategies are needed. One positive outcome of the heightened patient involvement in the screening process is an improved doctor-patient relationship. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Design considerations for AIDS trials

Article Abstract:

Pressure from a variety of citizen and scientific groups has become increasingly intense to change the ways drugs for treating AIDS are tested. A review is provided of the reactions of a group of statisticians to a document issued by the AIDS Coalition to Unleash Power (ACT UP) in June 1989. The report was entitled 'A National AIDS Treatment Research Agenda', which presented new principles for carrying out AIDS research. This article discusses some of the proposed changes in experimental design. One possibility is to run all three of the traditional drug testing phases concurrently. These include phase I, the study of drug safety; phase II, the study drug effectiveness; and phase III, which compares different drug treatments. Traditionally, phases II and III are randomized. Randomization could be extended to phase I. A discussion of the role of randomization in drug trials is presented. Randomization should be reserved for those patients for whom no treatment will be obviously preferable. Ultimately, randomized trials offer the best chance of accurately evaluating AIDS drugs. The issues of maintaining an untreated control group; the use of placebos; comparisons of different treatments and different drug doses; and the use of factorial designs, are discussed. More patients should be allowed to participate in drug trials, since the treatments tested will potentially be offered to all patients. This will also expand the applicability of results to the general population. Measures of treatment outcome include survival, rate of disease progression, and changes in biologic markers, such as blood cell levels. Patients participating in a trial of an AIDS drug who develop symptoms such as opportunistic infections should be allowed to enter a trial testing drugs against such infections. Other changes that could make clinical trials more accessible to patients and physicians are proposed. (Consumer Summary produced by Reliance Medical Information, Inc.)

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A comparison of the early outcome of acute myocardial infarction in women and men

Article Abstract:

There may be small differences between men and women in the rates of early death and complications following a heart attack. Some studies have suggested that women have as much as a 40% greater risk of death from heart attack. Researchers evaluated clinical complications and death in 9,600 women and 26,480 men during the first 35 days after they were hospitalized for heart attack. After adjusting for age and initial medical condition, the rate of stroke was 16% higher among women, and the rate of early death was 14% higher than the rate among men.

Mortality, Patient outcomes, Demographic aspects, Heart attack, Sex factors in disease, Disease sex factors

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