Recent advances in the field of biotechnology have created the potential for innovative therapies for the treatment of patients. These scientific innovations, however, have also created challenges in the assessment of efficacy in the clinical development process. Additionally, changes in the health care environment have led to increased demands on producers for information to be used in reimbursement decision making. Established methods of evaluation of more traditional therapies based on “clinical judgment” or the results of previous clinical trials may not meet these demands. This paper reviews the application of health services research techniques in the assessment of potential clinical endpoints and the time horizon of evaluation for clinical trials of innovative and more traditional clinical therapies.
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