Research in clinical practice.
Clinical research in the practice setting can be a rewarding experience. The atmosphere of research is changing, however, with tighter budgets, more oversight, increasing litigation risks, financial pressures, and increased competition. Sites must be increasingly careful to negotiate appropriate study budgets and contract language that is not overly burdensome or risky for the site. The focus on investigator training and use of qualifies personnel is paramount to preserve and improve the quality of clinical research in the United STates. The future may find certification examinations necessary for all research staff, including investigators. Eventually, the number of clinical research sites in the community will decrease, and academic sites, along with international sites, will once again fill the void.