BACKGROUND AND OBJECTIVE: There is evidence if the low rate of participation or even exclusion of women in clinical trials (CT), and that sex-differences are not considered in the design and analysis of the CT. The objectives of the study were to determine whether women are properly represented in the CT with rofecoxib and to analyze the information of CT with rofecoxib from a gender perspective. MATERIAL AND METHOD: Twenty eight rofecoxib CT in adults have been reviewed, all indexed in Medline and published between 1999-2001. The FDA Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation Drugs was used to analyze the information. RESULTS: An 80% of the trials do not describe efficacy results by sex, and only one reports side effects by sex. A 78.3% does not report stratified analysis by sex. In the discussion the possible difference by sex of the results is mentioned in 3 occasions. Only 8% of the CT considers the influence of hormonal variation in the results. The pharmacokinetics issues related specifically to women are poorly followed: in 60% of the CT it is not specified the influence of oral contraceptives in the results of the trial, and in 88.9% of CT it is not specified the influence of estrogen treatment in the results of the trial. Pregnancy as exclusion criteria is only considered in 50% of the trials. CONCLUSIONS: CT with rofecoxib has included more women than men. Important information on specific situation related to gender, recommends by FDA Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation Drugs, have not been followed.
BACKGROUND AND OBJECTIVE: There is evidence if the low rate of participation or even exclusion of women in clinical trials (CT), and that sex-differences are not considered in the design and analysis of the CT. The objectives of the study were to determine whether women are properly represented in the CT with rofecoxib and to analyze the information of CT with rofecoxib from a gender perspective. MATERIAL AND METHOD: Twenty eight rofecoxib CT in adults have been reviewed, all indexed in Medline and published between 1999-2001. The FDA Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation Drugs was used to analyze the information. RESULTS: An 80% of the trials do not describe efficacy results by sex, and only one reports side effects by sex. A 78.3% does not report stratified analysis by sex. In the discussion the possible difference by sex of the results is mentioned in 3 occasions. Only 8% of the CT considers the influence of hormonal variation in the results. The pharmacokinetics issues related specifically to women are poorly followed: in 60% of the CT it is not specified the influence of oral contraceptives in the results of the trial, and in 88.9% of CT it is not specified the influence of estrogen treatment in the results of the trial. Pregnancy as exclusion criteria is only considered in 50% of the trials. CONCLUSIONS: CT with rofecoxib has included more women than men. Important information on specific situation related to gender, recommends by FDA Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation Drugs, have not been followed.
Authors: María Teresa Ruiz-Cantero; Carmen Vives-Cases; Lucía Artazcoz; Ana Delgado; Maria Mar García Calvente; Consuelo Miqueo; Isabel Montero; Rocío Ortiz; Elena Ronda; Isabel Ruiz; Carme Valls Journal: J Epidemiol Community Health Date: 2007-12 Impact factor: 3.710