The choice of sites for planned clinical trials is a decision which often involves the greatest degree of uncertainty. The purpose of this paper is to present guidelines and available resources to aid in the evaluation of sites before a study is initiated, while the study is ongoing, and after a study is completed. The types of sites, components, and strategies for investigational techniques are explored. The advantages of using experienced versus novice investigators are compared using data from a multisite clinical trial.
AngellMKassirerJP. Setting the record straight in the breast-cancer trials. New Engl J Med.1994; 330(20): 1448–1450.
2.
LowryF. Dr. Roger Poisson: “I have learned my lesson the hard way.”Can Med Assoc J.1994; 151(6):835–837.
3.
SpilkerB. Guide to Planning and Managing Multiple Clinical Studies.New York, NY: Raven Press; 1987:41–48.
4.
MathieuM. New Drug Development: A Regulatory Overview.3rd edition. Waltham, MA: PAREXEL International Corp.; 1994: 132–133.
5.
McFarlandLVSurawiczCMGreenbergRN. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. JAMA.1994;271(24):1913–1918.
6.
VogelJRLinzmayerMI. Achieving results with contract research organizations: Evaluating and selecting CROs. App. Clin. Trials.1993; 1(8): 36–41.
7.
SouzaKSmallRD. The use of total quality management principles in placing and monitoring clinical trials. Drug Inf J.1995;29:695–703.
