| OWH advocates for participation of women in clinical trials and the analyses of data by sex.
- Adequate participation of women in clinical trials allows representation of the population most likely to use a disease therapy.
- Analyzing data by sex allows researchers to determine if there are any sex
differences in a disease therapy.
- Sex differences can include differences in disease prevalence and response.
- Analyses for sex differences can provide insight into the scientific basis for individual therapy differences and provide future directions for research.
OWH R&D program supports studies to track participation of women in clinical trials and collaborate with FDA centers to understand sex and gender differences in disease prevalence and response to therapy through science and research. FDA Center collaborations contribute towards the development of MaPPs, guidances and regulations to advance women’s health.
Past OWH Funded Studies Examining Participation of Women in Clinical Trials (21 KB pdf)
OWH Collaborations Examining Participation of Women in Clinical Trials
2006-2008
Gender Differences and Impact of Pharmacogenomics in Rheumatoid Arthritis.
Shashi Amur Ph.D., Center for Drug Evaluation and Research.
Impact of Gender Analysis and Pharmacogenomics on Clinical Efficacy, Safety, and Pharmacokinetics of Drugs Used for the Treatment of Alzheimer’s Disease.
Angela Men, Ph.D., Center for Drug Evaluation and Research
Evaluation of Availability and Quality of Information Available on Females Included in Mechanical Device Implant Trials. Kathryn O’Callaghan B.S., Center for Devices and Radiological Health
Women in HIV Trials: A Comprehensive Review and Meta-Analysis
Greg Soon, Ph.D., Center for Drug Evaluation and Research
Participation of Women in Clinical Trials and Gender Analysis of Data in Original NDAs Approved 2000-2002. Yongsheng Yang, Ph.D., Center for Drug Evaluation and Research
Statistical Analysis of Gender Specific Data from New Drug Application (NDA) Submissions. Ohidul Siddiqui Ph.D., Center for Drug Evaluation and Research
Identification of Sex Differences in Adverse Outcomes for New Molecular Entities (NMEs) Approved from 2000-2002.Yongsheng Yang, Ph.D., Center for Drug Evaluation and Research
OWH Collaborations Examining Participation of Women in Clinical Trials
CDISC: Clinical Data Interchange Standards Consortium.
The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.
2007
Enrollment of Women and Racial Minorities in Clinical Trials for Diabetes Medications
Ellen Pinnow MS, Pellavi Sharma MPH, Ameeta Parekh Ph.D., Kimberly Thomas MPH, Lina Aljuburi Pharm D, Kathleen Uhl M.D.
2006
Evaluation of NDAs Submitted to the FDA in CDISC SDTM Format: Feasibility of Using Demographic Domain Data to Track the Inclusion of Women in Trials. Presented at CDISC 2006 International Interchange, September 25-29, Bethesda, MD.
Ellen Pinnow MS
Sex Differences of Inclusion Criteria in Clinical Trials: A Regulatory Review of Contraception Requirements
Ellen Pinnow MS, Pamela Scott Ph.D., Janelle Derbis, Theresa Toigo RPh, MBA, Kathleen Uhl M.D.
Demographic Data on Sex in ASCPT Posters: Discrimination or Not?
Kathleen Uhl M.D., Ellen Pinnow MS, Katherine Hollinger D.V.M. |
