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  1. CDER Center for Clinical Trial Innovation (C3TI)

Clinical Trials Day

CDER Center for Clinical Trial Innovation (C3TI)

Clinical Trials: A Critical Part of Drug Development

We celebrate Clinical Trials Day on May 20, in recognition of what is often considered the start of the first randomized clinical trial. In 1747, James Lind began a clinical trial on this day to study the effects of different remedies for scurvy among sailors at sea. His research famously provided evidence of the benefits of citrus fruits to treat this disease. Clinical trials have undergone many changes since the time of James Lind, not only in respect to medical, scientific and technological advances, but also in terms of ethical and legal requirements. Regardless, clinical trials remain a critical part of drug development, as a means of generating evidence to support the regulatory decision-making for safe and effective new medicines.

Celebrate Clinical Trials Day

May 20 is an opportunity celebrate the individuals who participate in clinical trials, as well as those professionals who help run clinical research and the FDA staff who review and interpret results from these trials. It is also a chance to emphasize the importance of innovating clinical trials. Despite the tremendous progress we have made, there are new medical challenges and quandaries we have not solved — both of which require innovation and creative thinking. That is why through the CDER Center for Clinical Trial Innovation (C3TI) and other initiatives, CDER is working to further existing clinical trial innovation programs and spur future activities.  

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