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Clinical Trials for New Drugs Should Enroll Older Patients
Sponsors should include at least 100 geriatric
patients in trials of new drugs to detect clinically important differences between patient populations, according to an International Conference on Harmonisation
(ICH) question-and-answer (Q&A) document.
The recommendations are being made because of advances in the field of geriatrics since the ICH E7 guideline was
established in 1993, the ICH says in the Q&A posted on the FDA website this week. Comments on the draft are due Jan. 9.
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