From a patient's perspective, the principal questions about medical therapeutics are “Will I live longer or feel better?” and “What are the risks?” Until answers about the benefits of treatment on meaningful patient outcomes as well as about the attendant treatment risks are available, therapies have no role in the clinical armamentarium. Yet the answers to these deceptively simple questions often remain uncertain, even for some therapies commonly used in medical practice. The 2 faces of uncertainty for new therapeutics are hope and fear. The hope is that a treatment will provide meaningful benefits on patient outcomes. The fear is that, pending robust outcome studies, the only documented “benefits” of treatment may be for surrogate measures that may not translate into better outcomes or that any benefit will come at the expense of unacceptable risks.
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