Special Edition - December 2010 www.fda.gov/womens
Message from the Director
The Office of Women’s Health was established to protect and advance the health of women through policy, science, and outreach. In the early years, OWH focused a lot of its energy on establishing a science program and advocating within and outside the Agency for the participation of women in clinical trials. While OWH efforts have expanded to include our many Take Time To Care outreach initiatives, women’s health research remains at the core of what we do.
To close out the year, we are providing this special e-Update to highlight some of our current research activities. We are also working to find innovative ways to keep you informed about the research projects, workshops, and collaborations we support. To learn more, take a look at the articles below and visit our research website for future updates (www.fda.gov/womenshealthresearch).
Marsha Henderson, MCRP
Assistant Commissioner for Women’s Health (Acting)
Status of Women’s Participation in Clinical TrialsIn 1992 and 2001, the General Accounting Office (GAO) issued reports that examined the participation of women in clinical trials for new drugs submitted to the FDA. Two subsequent OWH-supported studies provided updates to the GAO data. Since the first GAO report, women’s participation has improved to approximately 50% in late phase clinical trials. Women’s participation in late-phase clinical drug trials was reported at 46% in 1992, 55% in 2001, and 49% for drugs approved in 2000-2002. Participation in early phase trials has increased from 22% (1998-2000) to 31% (2006-2007). Sex-based data analysis has also improved since 1992.
To Learn More:
Status of Women’s Participation in Clinical Trials. Journal of Women’s Health, 2010; 19:1771.
Data Standardization InitiativesFDA houses a vast repository of all clinical trials data submitted for regulatory review by sponsors. The major challenge to the electronic pooling of data across studies is the lack of consistent data standards. OWH is supporting FDA efforts to standardize clinical trials data into CDISC format to facilitate demographic and sex analyses for participation and outcome differences within and across regulatory submissions. OWH is also supporting pilot projects conducted by FDA Centers to convert legacy data to the CDISC format on some drug and biologics applications.
To Learn More:
FDA Resources for Data Standards
Prescription Drug User Fee Act (PDUFA) Information Technology Plans
Enrollment of Women in Cardiovascular Drug Trials
Cardiovascular disease is the number one killer of women. Historically, women were either excluded or under-represented in cardiovascular drug (CVD) clinical trials in the United States. OWH conducted a study to assess the participation of women in the FDA-reviewed CVD drug trials from 2007 to 2008. FDA clinical reviews of efficacy and safety data for 31 of 35 New Drug Applications (NDAs) submitted from Jan. 2007 to Dec. 2008 were reviewed to evaluate participation in the clinical trials by sex
Drugs reviewed were primarily for hypertension, pulmonary hypertension, acute coronary syndrome, heart failure and arrhythmia. Data indicated that women and men had nearly the same participation for hypertension and anti-arrhythmic drug trials. Pulmonary hypertension trials enrolled twice as many women as men while heart failure and acute coronary syndrome trials had higher participation of men. This may be reflective of disease prevalence and age on disease onset for men and women.
These findings were presented at the American Society for Clinical Therapeutics (ASCPT) annual meeting in Atlanta (Clin Pharm Ther 87(supp 1), S75 (Abstract # PIII-23, March 2009) and American Association for Pharmaceutical Scientists (AAPS) Annual Meeting, LA, CA, November 2009.
Since 1994, OWH has funded 29 oncology studies that have contributed to the understanding of treatment toxicities, tumor development and the detection/ prevention of cancer in women. In 2010, OWH completed a review and classification of the 19 studies that have been completed to date. The studies examined topics ranging from ways to improve the detection of breast cancer tumors and tumor progression, the economic benefits of mammography regulation, and procedures to monitor chemotherapy treatment response. Five studies also investigated tamoxifen toxicities and supported the black box warning of “serious and life-threatening uterine malignancies” in labeling that was added in 2002.
These findings were presented at the Women’s Health Conference 2010 (J Women’s Health 2010; 19(3):625 (Abstract #63) and Joint FIP/AAPS Annual Meeting, New Orleans, LA, November 2010.
Review of OWH-Funded Cardiovascular Studies
Between, 1994-2009, OWH funded 33 studies on cardiovascular (CVD). The studies examined disease presentation, prevalence, diagnosis as well as treatment and response differences. In addition, four studies examined women’s participation in clinical trials. Review of 10 premarket applications (PMA) for mechanical circulatory support devices showed women’s participation of 0-32.3% (mean 18.6%). A PubMed search of 57 articles showed women’s inclusion of 16.9%. Review of drugs/biologics trials for certain CVDs (1990-2000) showed women’s participation of 26% in phase 2 and 27% in phase 3 studies. In phase 1, 50 of 75 studies did not enroll women. OWH funded studies have generated important information regarding sex differences in treatments and outcomes for drugs, devices and biologics products regulated by FDA.
These findings were presented at the Women’s Health Conference 2010 (J Women’s Health 2010; 19(3):612 (Abstract #25) and Cardiovascular Research Technologies (CRT) 2010 annual meeting, Feb 21-23, Washington, DC.
To learn more about the oncology, CVD, and other OWH-funded research, visit:
http://www.fda.gov/womenshealthresearch
Lupus is an autoimmune disease that primarily affects women of color. OWH is collaborating with the FDA Center for Drug Evaluation and Research to conduct a workshop on lupus to be held March 28-30 at the FDA White Oak Campus. The workshop will discuss the clinical complexities of the disease, issues with
diagnosis and treatment, causes of clinical trial failures, and potential biomarkers for disease detection and treatment. FDA processes for biomarker qualification will also be addressed.
Workshop Details are forthcoming.
Ameeta Parekh, OWH Research & Development Director, was invited to present at the Symposium on Gender Medicine for the 200th Anniversary of the Karolinska Institute of Sweden. In her talk, “The American Regulatory Perspective on Women in Clinical Trials”, Dr. Parekh presented a review of the issue in U.S. regulatory applications and advancements in FDA regulations and guidance.
Updated Pregnancy Registry Website
More than 60% of pregnant woman are prescribed one or more drugs during pregnancy for chronic or acute conditions. To facilitate the collection and analysis of data on prescription drug use during pregnancy, OWH has updated and re-launched its Pregnancy Exposure Registry Web Portal. Accessible by health care providers and pregnant women, the portal lists contact information for 41 pregnancy registries and provides links to FDA and external resources on pregnancy.
Pregnancy exposure registries provide prospective observational data on pregnancy and fetal outcomes that can help inform regulatory decision making and provide healthcare practitioners with information to counsel women about prescription drug use during pregnancy. The OWH Pregnancy Exposure Registry Portal is the only web site that lists information for all available registries in one location.
www.fda.gov/pregnancyregistries
To Learn More:
FDA Calls Attention to Pregnancy Exposure Registry. Journal of Women’s Health, 2010; 19:1052
FDA Consumer Update: Registries Help Moms Measure Medication Risks
Upcoming OWH/HRSA Presentation
OWH and the HRSA Office of Pharmacy Affairs will be featured in a podium presentation at the American Academy of Nurse Practitioners 26th National Conference. The presentation will highlight the joint OWH/ HRSA project to utilize OWH health education materials to better enable clinical pharmacists and nurse practitioners to instruct patients on the safe use of prescription and over-the-counter medications. The project is a part of the HRSA Patient Safety and Clinical Pharmacy Services Collaborative (PSPC) which is a national initiative to integrate evidence-based clinical pharmacy services into the care and management of high-risk, high-cost patients.
In its third year, PSPC has formed a cadre of national partners and over 120 community-based teams in 45 states, DC and Puerto Rico that have demonstrated improved health outcomes and patient safety. Data from current PSPC teams indicate that 54% of patients once identified as “out of control” or not optimally medically managed, are now “under control” across a range of chronic conditions using standardized measures. Adverse drug events (ADEs), or actual events that cause patient harm, have also decreased by an average of 49% for this high risk patient population.
Presentation: HRSA’s Patient Safety and Clinical Services Collaborative
Presenters: CDR Karen C Williams (HRSA) and Beverly Gallauresi (FDA)
Meeting Location: Las Vegas, NV
Date: June 24, 2011
To Learn More: HRSA PSPC Website
Update Extras
FDA Guidances and Regulations:
Women in Clinical Trials and Race/ Ethnicity Data
Check the links to view FDA Center for Drug Evaluation and Research (CDER) guidances on gender and race/ethnicity of patients in clinical trials and regulations detailing sponsor requirements for clinical trials data submission.
Guidance Documents
▪ Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs: This guidance outlines FDA's expectations regarding inclusion of both genders in drug development. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072044.pdf
▪ Collection of Race and Ethnicity Data in Clinical Trials: This guidance recommends using a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071596.pdf
Regulations
▪ Investigational New Drug Applications (IND) and New Drug Application (NDA) regulations (21 CFR 312.33 and 21 CFR 314.50): These regulations require that NDAs contain information on clinical trial participation as well as analysis of safety and efficacy broken down for sex, age, and racial subgroups, and required the IND annual reports to tabulate the number of participants enrolled according to sex, age, and racial subgroups.
▪ The Amendment to Clinical Hold Regulations (21 CFR 312.42): These regulations allowed FDA to stop IND studies for treatment of life-threatening diseases if women or men were excluded primarily due to their reproductive potential.
Want more information from the FDA Office of Women’s Health?Follow OWH on Twitter: www.twitter.com/fdawomen
Visit the OWH website: www.fda.gov/womens
Attend an OWH Presentation: OWH Presentations
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