Noa Laguna Goya1, Fernando de Andrés Rodríguez-Trelles. 1. División de Farmacología y Evaluación Clínica, Subdirección General de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Ministerio de Sanidad y Consumo, Madrid, Spain. nlaguna@agemed.es
Abstract
BACKGROUND: The evaluation of the gender bias in clinical trials is not unanimous. The aim of this study has been the assessment of the current situation in Spain regarding the manipulation of data from clinical trials at the publication of the Law of Equality. METHODS: We have examined the study design, sample population, demographic data and baseline clinical characteristics of participants, results and conclusions of the trial in the summaries of the final reports of clinical trials received in the first four months of 2007 in the Agencia Española de Medicamentos y Productos Sanitarios. RESULTS: From twenty-five documents analysed, in their results and conclusions: Five subdivide data sets by age and gender, thirteen do not subdivide data by gender nor do they provide a conclusion, three do not subdivide results neither but do describe severe side effect by gender and four others provide no results or conclusions. CONCLUSIONS: Only twenty percent of the reviewed summaries provide data subdivided by gender. This could be due to the fact that it has not been made or that it was not given enough importance to include it in the summary, neither of which is satisfactory. A more detailed study is difficult due to the current quality of the summaries provided of the final reports of the clinical trials, which is the only document that is mandatory to send to the AEMPS once the trial has concluded. We expect that with the publication of the new Law of Equality this situation will improve, given the growing evidence of the relevance of the subdivision by gender.
BACKGROUND: The evaluation of the gender bias in clinical trials is not unanimous. The aim of this study has been the assessment of the current situation in Spain regarding the manipulation of data from clinical trials at the publication of the Law of Equality. METHODS: We have examined the study design, sample population, demographic data and baseline clinical characteristics of participants, results and conclusions of the trial in the summaries of the final reports of clinical trials received in the first four months of 2007 in the Agencia Española de Medicamentos y Productos Sanitarios. RESULTS: From twenty-five documents analysed, in their results and conclusions: Five subdivide data sets by age and gender, thirteen do not subdivide data by gender nor do they provide a conclusion, three do not subdivide results neither but do describe severe side effect by gender and four others provide no results or conclusions. CONCLUSIONS: Only twenty percent of the reviewed summaries provide data subdivided by gender. This could be due to the fact that it has not been made or that it was not given enough importance to include it in the summary, neither of which is satisfactory. A more detailed study is difficult due to the current quality of the summaries provided of the final reports of the clinical trials, which is the only document that is mandatory to send to the AEMPS once the trial has concluded. We expect that with the publication of the new Law of Equality this situation will improve, given the growing evidence of the relevance of the subdivision by gender.