Daniel D. Federman, MD
Potential Conflicts of Interest: None disclosed.
Requests for Single Reprints: Daniel D. Federman, MD, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115.
Federman D.; Minimizing Risk in Clinical Research. Ann Intern Med. 2003;139:71-72. doi: 10.7326/0003-4819-139-1-200307010-00015
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Published: Ann Intern Med. 2003;139(1):71-72.
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.
Normal volunteers and patients are by far the most important participants in the process. Since many of these are in the group receiving the placebo, and since many trials fail, many sick and well participants have little likelihood of benefiting in the trial. The protection of these individuals from harm is therefore a compelling moral responsibility.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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