Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials

Autor:	Ann Jeanette Davis, Daniel R. Mishell, John Guillebaud, Andrew M. Kaunitz, James Trussell, Anita L. Nelson, Carolyn Westhoff
Rok vydání:	2007
Předmět:	Gynecology medicine.medical_specialty education.field_of_study Data collection business.industry Population MEDLINE Alternative medicine Obstetrics and Gynecology Clinical trial Clinical research Reproductive Medicine Family planning Family medicine medicine education business Developed country
Zdroj:	Contraception. 75:11-15
ISSN:	0010-7824
DOI:	10.1016/j.contraception.2006.08.012
Popis:	This is the second of a two-article series describing the outcomes of the Hormonal Contraceptives Trial Methodology Consensus Conference held in Philadelphia, PA, on September 23, 2005. The first manuscript, "Hormonal Contraceptive Trials: Variable Data Collection and Bleeding Assessment Methodologies Influence Study Outcome and Physician Perception," provided a description of methodologies applied in the US Food and Drug Administration medical officer's review of clinical trial data as contained in the Summary Basis of Approvals of New Drug Applications, results of the review and general conclusions. This manuscript provides recommendations regarding best practices in trial design, data collection and analysis regarding bleeding data in combined hormone contraception trials.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::594f32a9e7ce918de3ab760f6d25f63b https://doi.org/10.1016/j.contraception.2006.08.012 Zobrazit plný text záznamu Full Text from ScienceDirect