Clinical trials high risk individuals

In high-risk individuals and groups people with clinical evidence of macrovascular disease other than CHD, the Heart Protection Study (HPS) (II) with diabetes, the HPS and Collaborative Atorvastatin Diabetes Study (CARDS) (12) the elderly, Prospective Study of Pravastatin in the Elderly at Risk (PROSPER) (13) or with hypertension, Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) (14) and Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) (15). 

There is a lack of agreement among clinicians as to whether patients with stage II colon cancer should receive adjuvant chemotherapy. Some believe all patients should receive some form of chemotherapy, while others only recommend treatment or clinical trials for high-risk individuals. 

Based on this concept of correlation between high replication rate/high persistent mutation risk, Pike et al. (1983) formulated the hypothesis of breast tissue age and developed a mathematical model to predict the effects of exposure to ovarian hormones. This model incorporates reproductive and endocrine items related to breast cancer and is able to predict the relative risk of individual situations with results that are very close to those observed in clinical trials. According to this hypothesis, both the years of exposure and the circulating serum levels of estrogens are associated to short-term breast cancer risk in postmenopausal women (Toniolo et al. 1995). 

Many ongoing clinical trials for efficacy and toxicity of new pharmaceutical products or new indications for previously developed pharmaceuticals have employed pharmacogenetic testing. Thus it is anticipated that pharmacogenetic guidelines and possibly tests will be simultaneously released to market with the pharmaceutical. In addition, medications that were previously removed from development because of adverse reactions may be reconsidered if a genetic test can be demonstrated to identify individuals at high risk for ADRs. 

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