The Impact of Clinical Trials on Clinical Practice
In the process of deciding whether to fund a clinical trial, the sponsor weighs the investment of dollars, effort, and time against the information the trial is likely to generate. Varying objectives are reflected in the trial design. For example, a new drug goes through several phases of development, from dose-response studies to large, randomized clinical trials. Industry-sponsored, large-scale trials are primarily designed to document an anticipated beneficial effect, while federal agencies or foundations may have a broader interest in determining whether an intervention effect is beneficial, indifferent, or even harmful. It is important to distinguish between these goals in any analysis of the impact of clinical trials on medical practice. Moreover, it should be recognized that clinical practice itself cannot be measured directly. Indirect measures such as number of patient visits by clinical diagnosis as well as drug prescriptions or sales can indicate the impact of clinical trials. Physician interviews can provide additional information in terms of knowledge, prescription habits, perceived effectiveness, and safety. However, this approach has drawbacks, including cost.
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