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For decades, Good Clinical Practice (GCP) has provided the ethical and scientific foundation for clinical investigations submitted to the U.S. Food and Drug Administration. Its purpose is straightforward: establishing a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that helps ensure that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected. All clinical trials of investigational products submitted to the FDA must comply with GCP.
Today, this foundation is being tested by the scale and globalization of modern clinical research. While there are various benefits to this global expansion, it is also introducing new risks to oversight, transparency, and data integrity. Multi-regional trials without an American patient at all or with only a small percentage of patients in the United States present a variety of concerns for American patients, for the FDA, and, increasingly, for policymakers in Congress. Trials that fail to enroll American patients can be less easily generalized to the population the products are intended to treat. It also means Americans are losing out on the opportunity to participate in trials of innovative or breakthrough medical products.
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