Points to consider in designing a clinical trial to ascertain the utility of a genetic screening test.
In designing a clinical trial to ascertain the utility of a genetic screening test, the follow recommendations should be considered: (1) imbed the genetic test in a genetic service; (2) choose a specific outcome to monitor; (3) compare two strategies for achieving the desired outcome; (4) assemble a multidisciplinary team; (5) attempt to reach all potential subjects in a defined region; (6) derive an outcome for each subject; (7) assess each expected benefit and burden.
Rowley
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Division of Genetics, University of Rochester School of Medicine, 601 Elmwood Avenue, Box 641, Rochester, NY 14642-0001, USA. peter_rowley@urmc.rochester.edu
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D002986:Clinical Trials as Topic; D005820:Genetic Testing; D012107:Research Design