| Autor: |
Ling Chen1 ling.chen@fda.hhs.gov, Moh-Jee Ng1, Van der Vlugt, Theresa H.2, Price, Phill H.2, Orencia, Anthony3 |
| Předmět: |
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| Zdroj: |
Drug Information Journal. Sep2010, Vol. 44 Issue 5, p581-588. 8p. 5 Charts. |
| Abstrakt: |
The US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Division of Reproductive and Urologic Products (DRUP) released its draft "Guidance for Industry: Estrogen and Estrogen/ Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommendations for Clinical Evaluation" in 2005. The guidance references the assessment of safety and efficacy of estrogen and estrogen and progestin drugs indicated for the treatment of moderate to severe vasomotor symptoms and the treatment of moderate to severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause. Since the release of the draft guidance, DRUP has reviewed several VVA clinical studies in new drug applications. Statistical issues with the coprimary endpoints in WA studies have been raised by the pharmaceutical industry and some reviewers within the FDA. In this article, we discuss statistical issues in VVA studies and provide methodologies to improve the efficacy assessment for the VVA indication. These include the following recommendations: (a) that the "most bothersome symptom designation" be removed from the coprimary endpoint of mean change from baseline to week 12 in the moderate to severe symptom that has been identified by the patient as being the most bothersome to her, and (b) that the drug efficacy assessment criteria be modified. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Library, Information Science & Technology Abstracts |
| Externí odkaz: |
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