Introduction
Richard Vinci, 51, an engineering professor at Lehigh University, is participating in a clinical trial for treatment of amyotrophic lateral sclerosis, or Lou Gehrig's Disease, at Massachusetts General Hospital in Boston. It is the first late-stage U.S. trial to determine if stem cells harvested from bone marrow, modified and then injected into spinal fluid, will halt or slow the fatal disease. (Cover: Getty Images/The Boston Globe/David L. Ryan)
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Clinical trials are designed to answer questions about the safety and effectiveness of experimental drugs, medical devices, vaccines and behavioral therapies. The U.S. Food and Drug Administration relies on trials when considering whether to approve new medical treatments or new uses for existing drugs and devices. But the clinical trials system in the United States is in crisis. Few patients participate, causing nearly a fifth of trials to shut down early or before they even begin. In addition, trials are becoming increasingly long, complex and costly. The net effect, many medical experts warn, is that health care innovation and advances are threatened. Analysts have proposed some controversial remedies: requiring drug companies to publicly release more trial data to increase trust in their results, broadening eligibility requirements to attract more participants, involving patients in the design of clinical trials and incorporating the use of smartwatches and other wearable biosensors to gather data, which could make trials easier and cheaper to conduct.
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