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Statistics in medicine · Jul 1994
Some practical aspects of the interim monitoring of clinical trials.
- R Simon.
- National Cancer Institute, Biometric Research Branch, Rockville, MD 20852.
- Stat Med. 1994 Jul 15;13(13-14):1401-9.
AbstractThe decision to stop accrual early to a clinical trial is often difficult and multifaceted. Interim monitoring boundaries have been found useful in U.S. oncology trials for such decisions for reasons described here. This paper also discusses rationale that lead to more conservative approaches to early stopping decisions than are currently employed. A recent initiative of the National Cancer Institute to achieve the objectives of independent data monitoring committees in the phase III clinical trials which it sponsors is also described.
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