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Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring
The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding o...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4766962/ https://www.ncbi.nlm.nih.gov/pubmed/27042398 http://dx.doi.org/10.1177/2168479015608415 |
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author | Stewart, J. Breslin, W. J. Beyer, B. K. Chadwick, K. De Schaepdrijver, L. Desai, M. Enright, B. Foster, W. Hui, J. Y. Moffat, G. J. Tornesi, B. Van Malderen, K. Wiesner, L. Chen, C. L. |
author_facet | Stewart, J. Breslin, W. J. Beyer, B. K. Chadwick, K. De Schaepdrijver, L. Desai, M. Enright, B. Foster, W. Hui, J. Y. Moffat, G. J. Tornesi, B. Van Malderen, K. Wiesner, L. Chen, C. L. |
author_sort | Stewart, J. |
collection | PubMed |
description | The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. |
format | Online Article Text |
id | pubmed-4766962 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-47669622016-04-01 Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring Stewart, J. Breslin, W. J. Beyer, B. K. Chadwick, K. De Schaepdrijver, L. Desai, M. Enright, B. Foster, W. Hui, J. Y. Moffat, G. J. Tornesi, B. Van Malderen, K. Wiesner, L. Chen, C. L. Ther Innov Regul Sci Clinical Trials The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. SAGE Publications 2015-10-08 2016-03 /pmc/articles/PMC4766962/ /pubmed/27042398 http://dx.doi.org/10.1177/2168479015608415 Text en © The Author(s) 2015 http://creativecommons.org/licenses/by-nc/3.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Clinical Trials Stewart, J. Breslin, W. J. Beyer, B. K. Chadwick, K. De Schaepdrijver, L. Desai, M. Enright, B. Foster, W. Hui, J. Y. Moffat, G. J. Tornesi, B. Van Malderen, K. Wiesner, L. Chen, C. L. Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring |
title | Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring |
title_full | Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring |
title_fullStr | Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring |
title_full_unstemmed | Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring |
title_short | Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring |
title_sort | birth control in clinical trials: industry survey of current use practices, governance, and monitoring |
topic | Clinical Trials |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4766962/ https://www.ncbi.nlm.nih.gov/pubmed/27042398 http://dx.doi.org/10.1177/2168479015608415 |
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