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Biological therapies need definitive randomized controlled clinical trials
Robert M Califf1,2, Peter W Marks1,2
1Robert M. Califf is the commissioner of food and drugs, U.S. Food and Drug Administration, Silver Spring, MD 20903, USA.
Science Translational Medicine
|January 25, 2023
Summary
Well-designed clinical trials are essential for delivering new medical benefits to patients. These rigorous studies ensure that treatments are safe and effective for those with unmet medical needs.
Area of Science:
- Medical Research
- Clinical Pharmacology
Background:
- Clinical trials are fundamental to medical advancement.
- Ensuring patient benefit requires rigorous study design.
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