FDA’s OWH will launch the Women’s Health Research Roadmap beginning with the FY 2017 grants cycle. The conversations, feedback, and analysis during the Roadmap’s planning and vetting phases have laid the groundwork for implementation. OWH will undertake the following as it begins to identify, review, and fund research projects in the seven priority areas.
Enhance Intra-Agency Collaboration
OWH will work with FDA centers to increase collaboration and communication across research endeavors related to women’s health. This will include increasing alignment of the OWH funding programs to support center research projects.
Establish a Formal Women’s Health Research Steering Committee (WH Steering Committee)
Once fully formed, the WH Steering Committee, with representatives from FDA centers and key offices, will help identify and refine research priorities and enhance collaboration and communication within FDA and with external stakeholders. One of the WH Steering Committee’s key roles will be to assist OWH in staying abreast of advances and emerging issues affecting women’s health and scan the horizon for important women’s health research areas. The WH Steering Committee will also help expand and refine metrics for assessing program success and align funding decisions with FDA’s regulatory science priorities.
Implement Mechanisms to Facilitate WH Research
OWH will revise the current OWH grant funding structure and requirements to better support cross-center collaborative projects. For example, OWH will consider projects that exceed the previous funding cap and time limits, provided the scope and impact of the projects merit such consideration, and there is a high degree of cross-center and/or external collaboration. This new funding structure should enable a more comprehensive analysis of the factors affecting toxicity or safety and efficacy. In some cases, OWH will ask for support (e.g., personnel and/or resources) from the centers.
Revisions to the current approach will enable OWH to supplement research underway to incorporate the examination of sex and gender differences. For example, grants will be awarded for adding animals, tissues, cells, or subjects to original grants to facilitate sex analyses (e.g., adding subjects of the opposite sex to a single sex or gender study; adding more subjects of either sex to a sample of both males and females to increase the statistical power of sex analyses) and for further exploration of the mechanisms of any sex differences observed in previously OWH-funded or other FDA-funded projects. 42
Improve General Funding Criteria
Based on input from stakeholders while developing the Research Roadmap, OWH identified important factors to consider when identifying research projects for OWH Funding. For example, does the research align with the principles outlined within the Roadmap and with FDA’s priorities and strategic goals? Research addressing a knowledge gap in relation to public health needs of women or where women have few therapeutic options would be viewed favorably. Specific research funding guidelines surrounding these factors will be defined by OWH and the WH Steering Committee.
The OWH funding mechanism seeks to increase collaboration across FDA centers. For example, OWH would be very interested in supporting new health research projects in the centers, or projects already underway in the centers, that focus on women’s health issues. OWH will also continue partnering with investigators who previously received OWH grants when their research appears to be leading to successful outcomes, or OWH-sponsored work that may require additional support to achieve a successful outcome.
In summary, when selecting projects for funding, OWH will consider a number of factors, for example:
- Does the research address a priority area outlined in the Roadmap?
- Is the research aligned with FDA’s regulatory science priorities or other strategic goals?
- Does the project address a regulatory question with the potential for regulatory impact, policy changes, or revised industry standards?
- Does the project address an area of unmet public health or an area where women have few therapeutic options?
OWH will also consider whether the project is an outgrowth or extension of research previously funded by OWH that has demonstrated the potential to produce regulatory impact or significant scientific impact and if the research addresses issues that can be investigated through collaborations across the FDA centers. Research funding priorities will be refined as needed by OWH and the Women’s Health Research Steering Committee.
42 This project mirrors a similar effort underway since 2013 at the National Institutes of Health. See NIH News and Events announcement. Accessed March 2015.