Modern Methods of Clinical Investigation (1990) / Chapter Skim
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2. The Selection of Endpoints in Evaluation Research
2. The Selection of Endpoints in Evaluation Research
Pages 16-22
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From page 16... ...
SURROGATE VERSUS CLINICAL ENDPOINTS The surrogate-versus-clinical endpoints battle is particularly prominent now in the drug arena. The issue is when new drugs should be released for clinical use.
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From page 17... ...
My personal view reflects a concern for the risks, both known and unknown, of hastily introduced technology. I believe it was Harold Green, chair of the 1973 Artificial Heart Assessment Panel, who suggested that a delay in introducing a new therapy means only that the public has to live with the status quo, while the widespread use of inadequately tested treatments can possibly expose the public to substantial harm.
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From page 18... ...
The investigators found the predicted association between cholesterol level and cardiac deaths, but the reduction in cardiac deaths associated with lower cholesterol was offset by an equal increase in cancer deaths. You may be familar with the unpleasant fact that in three major lipid drug trials, the fall in cardiac mortality associated with lower blood cholesterol was offset by increased accidental deaths in the experimental groups, and total mortality was unchanged (3,4,5~.
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From page 19... ...
It is not quite so easy to accept the inevitable complications and ill effects of other therapies, such as the severe malabsorption problems that followed gastric bypass surgery, metabolic imbalances that could have been easily predicted. Two common operations that are performed to improve quality of life may have an opposite effect.
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From page 20... ...
A third interesting and sobering example is the recent report that, in randomized clinical trials comparing mastectomy with mastectomy plus radiation to the chest wall for breast cancer, there was a late increase in serious cardiac events, coronary artery disease, and unrelated malignancies in the group receiving radiation (11~. With :-PA and chymopapain the adverse effects were detected very quickly.
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From page 21... ...
The use of surrogate endpoints has also been explored with some enthusiasm for cancer chemotherapy, with shrinkage of tumor size the usual proposed surrogate for increased life expectancy. However strong the association between such surrogates and their intended effects may prove to be, a serious limitation of surrogates as a basis for evaluation is that none of the offsetting adverse effects can be determined when SU~Togate outcomes are used.
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From page 22... ...
BUNKER 4. Coronary heart disease death, nonfatal acute myocardial infarction and other clinical outcomes in the Multiple Risk Factor Intervention Trial Research Group.
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