Health of Women (HoW) Program Launch: Participant Workbook

What did the Participant Workbook use to help you get involved in the work?
What did the program launch take place?
What is one of the main goals of medical device studies?

Transcription

1 Health of Women (HoW) Program Launch: Participant Workbook June 24-25, 2013 Name: Title: Affiliation /Organization: Workbook completion instructions: Record your action-oriented ideas throughout the day Discuss at small table groups during the first breakout session Extract most effective or promising strategies into the action plan during the second breakout session Hand in your completed workbook OR submit electronically before leaving the workshop to: Additional blank sheets are provided at the end of your workbook for personal notes to take with you U.S. Food and Drug Administration - Center for Devices and Radiological Health

2 Health of Women (HoW) Program Launch: Participant Workbook Based on the discussion at your table, define specific shared goals, strategies, and approaches that need to be accomplished by each of the stakeholder groups identified in the first column. Please include suggestions that need to be addressed in the next 6 months (Immediate), in 1-2 years (Mid-Range), and in 3-5 years (Long-Range). Please fill-in, tear off sheet and hand-in. Healthcare Practitioner Patients & Advocacy Groups Investigators & Researchers Industry & Study Sponsors FDA Strategies & Approaches ( What ) Tools & Vehicles ( How ) Potential Partners ( Who ) Immediate, Mid or Long Range Goals ( When ) Professional Societies Federal Funders Venture Capital and other private funders Other Page 2 of 13

3 Getting to Goal Thinking About Your Place in the Medical Device Ecosystem Within your space (e.g. as a manufacturer, innovator, clinical researcher, healthcare practitioner, patient, patient advocate, scientist, policy maker, etc): 1) Recruitment & Retention Strategies: List the top 3 areas relevant for medical device studies where increased recruitment and retention of women is needed. List effective strategies for overcoming barriers to appropriate accrual of women, which could be practically applied to medical device studies. Identify needs or incremental actions that can be taken (information, data, toolkits, incentives, etc.) to motivate greater adoption and commitment to inclusion of women in research amongst study sponsors? 2) Communication Strategies: How do we effectively communicate sex- and gender-specific medical device information to diverse audiences in a timely manner? List sources you rely on for information related to medical device use and to the health of women. List at least 3 ways to maximize the value and impact of sex- and gender-specific information to inform innovation, research and regulatory science. Page 3 of 13

4 Health of Women (HoW) Program Launch Participant Workbook June 24, 2013 Plenary 1: Device-Specific Recruitment and Retention Strategies 1. List the top 3 clinical research areas where increased recruitment and retention of women is needed. Please consider: How do you determine the appropriate representation of women for your research area? 2. List 3 effective strategies for overcoming barriers to appropriate accrual of women, which could be practically applied to medical device studies. Please consider: What top 3 strategies have worked in your space or could be adapted for the particular barriers in your space? What data or information is available supporting the successful implementation of these strategies? What new strategies could be tested / piloted? Who/what are the partners/resources necessary to develop a successful pilot? Page 4 of 13

5 3. Identify needs or incremental actions that should be taken (information, data, toolkits, incentives, etc.) to motivate greater adoption and commitment to inclusion of women in research amongst study sponsors. Please consider: Define the top 3 methods to educate o sponsors o investigators o referring physicians How do we test potential strategies? How should we measure success of these pilot strategies? What benchmarks and measurements should be utilized to measure progress overall? What would success look like from your perspective? Page 5 of 13

6 Health of Women (HoW) Program Launch Participant Workbook June 24, 2013 Plenary 2: Communication of Sex-Specific Research Findings 1. How do we effectively communicate sex- and gender-specific medical device information to diverse audiences in a timely manner? Please consider: Diverse messages (for device labeling, to providers and patients to guide tailored care, to inform future research, etc) Intended audience (patients, providers, researchers) and differences in communication Delivery (i.e. tools, vehicles, avenues, mechanisms) Frequency of data / information reporting 2. List sources you rely on for information related to medical device use and to the health of women. Please consider: How do women approach healthcare decision-making? Health seeking behaviors? Consider different tolerance of risk and valuation of benefit for different subsets (e.g. pregnant/lactating, elderly, disease-specific) Page 6 of 13

7 3. List at least 3 ways to maximize the value and impact of sex- and gender-specific information to inform innovation, research and regulatory science. Please consider: How do we get more useful information out of available sex/gender-specific data? In cases where data analysis leads to hypothesis-generating findings, how can we stimulate collaborative research? Who do you believe are the responsible parties/partners? Page 7 of 13

8 Health of Women (HoW) Program Launch Participant Feedback June 25, 2013 As CDRH develops and refines a Priority Research Road Map for the HoW Device EcoSystem, your input and suggestions will be taken into consideration. Please complete the questions based on what you hear during the day and based on your own perspectives and expertise. For additional background and guiding information, refer to page 10. Plenary 3: Research Road Map 1. What are the priority areas where we should be asking focused sex- or gender-specific questions within medical device research agendas? What specific questions should be asked within those areas? What do we need to know? 2. Are there common themes to be explored across priority areas, e.g., related to sexdifferences in anatomy, physiology, patient reported outcomes (PRO) in pain or function, inflammatory response, bleeding/clotting, materials science, imaging? Page 8 of 13

9 Participant Feedback June 25, Based on what was discussed in the plenaries and your sphere of influence, how would you prioritize research efforts related to the health or women? 4. How can we influence /spur innovation to address identified needs and gaps in the priority HoW device ecosystem areas? Page 9 of 13

10 Research Road Map Background June 25, 2013 What would a potential Research Road Map for the HoW device ecosystem entail? Identify regulatory science research priorities (i.e. outline research agendas for the high priority disease areas e.g. musculoskeletal, cardiovascular, women specific) to allow for appropriate funding and resource allocation. Identify cross-cutting comprehensive women-specific research considerations for incorporation into a research agenda (e.g. unique anatomy/pathophysiology considerations that may influence device design, hormonal influences i.e. from menarche through to menopause etc). Create innovative research to address identified gaps/needs in priority areas. Develop the infrastructure and collaborations/relationships to support improved health outcomes for the health of women. Identify a set of milestones with forecasted completion dates to measure outcomes. Goals for Research Agendas Within Priority Areas Develop a basic outline of a research agenda that takes into account clinical, basic science, and epidemiological factors, to achieve 3 main goals: (1) identify gaps/needs, (2) prioritize research and resources, and (3) influence/spur innovation to address prioritized needs. Within 5 years: 1) Device clinical studies will be designed to evaluate clinically meaningful sex differences in outcomes 2) Sex-specific device outcome information will be communicated in a way that is meaningful to healthcare practitioners and patients 3) Research will consistently account for the unique differences in women so the appropriate considerations will be taken into account, for example: a. Is this product likely to be used in women? b. Will the use of this product in women likely raise different issues and outcomes? c. If you where to design, develop a market this product, what women specific questions do you need to take into consideration? Page 10 of 13

11 Please consider the following factors for the HoW ecosystem research agenda: Biological Sex: Genetic or phenotypic factors Anatomy Physiology Hormonal milieu Comorbidities What biological differences matter o For performance? (outcomes) o For trial design? (covariates, confounding) o For device design? (anatomical or use parameters, materials) Baseline characteristics (disease prevalence, incidence, manifestation, comorbidites) Should preclinical testing be performed in animals that are female, pregnant, etc.? What is the role of genomics? Clinical and Social Gender: PRO (patient reported outcomes), e.g., pain response behaviors, quality of life Recruitment and retention Physician and/or patient bias Comorbidities What do we know about the safety and effectiveness of medical devices in women: o In general? Compared to men? o Those of child bearing potential? o Who are pregnant? Lactating? The impact on fetus? o Throughout the menstrual cycles; menarche menopause; those on postmenopausal hormone therapy? o Ethnic/racial differences in female populations What other aspects make women a special population in need of targeted policy and research development? Why do women continue to be excluded / underrepresented in clinical studies? Overarching factors: Research outcomes Prevention Sex-specific device development Novel technologies and innovation Page 11 of 13