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Minimizing Risk in Clinical Research

Daniel D. Federman, MD
[+] Article and Author Information

From Harvard Medical School, Boston, MA 02115.

Potential Conflicts of Interest: None disclosed.

Requests for Single Reprints: Daniel D. Federman, MD, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115.

Ann Intern Med. 2003;139(1):71-72. doi:10.7326/0003-4819-139-1-200307010-00015
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The randomized clinical trial, the gold standard of modern clinical investigation, is a remarkable social construction. Its overall goal is the scientific demonstration that a new drug or device produces a health benefit that justifies its risk. Ultimately, the therapeutic fruits of all biomedical advance have to be submitted to this scrutiny before they can enter clinical use.

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