Dear BDRP/OTIS Member,
Please take a few minutes to complete the attached brief questionnaire. At our 2019 Annual Meeting, a work group of volunteers was formed to lead advocacy efforts on behalf of both societies to positively influence the NIH Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC). We know that many members have expertise in the focus areas of the Task Force. Your survey response will advance our advocacy efforts through greater awareness of ongoing work relevant to the goals of the PRGLAC Task Force, governmental funding agencies, and our societies.
Sincerely,
BDRP/OTIS PRGLAC Workgroup

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* 1. What is your name?

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* 2. What is your email address?

Questions 3-6 pertain to the PRGLAC Task Force Work Group on Research and Training.

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* 3. If additional federal research grants were available, what conditions or medications would your organization suggest studying (or be in a position to study) to address gaps in research or access (and how much funding would you need to conduct the study)?

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* 4. Can you provide an example where funding would facilitate advances in research or training by promoting collaboration using shared sample repositories, electronic data, or other means?

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* 5. Are you involved with evidence-based training of health workers in therapeutics during pregnancy and lactation?

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* 6. If yes, what types of health workers do you train?

Questions 7-9 pertain to the PRGLAC Task Force Work Group on Regulatory Recommendations.

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* 7. Does your work involve clinical or nonclinical assessment and/or approval of therapies for women during pregnancy and/or lactation?

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* 8. Can you provide an example of a regulatory barrier that, if removed, would stimulate assessment or approval?

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* 9. What data gaps for assessing the efficacy and safety of treatment during pregnancy and/or lactation would you prioritize as being most useful for risk/benefit decision analysis?

Questions 10-15 pertain to the PRGLAC Task Force Work Group on Communication.

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* 10. Does your work involve evidence-based risk/benefit or exposure communication to pregnant women or through policy development?

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* 11. If yes, can you briefly describe the methods you routinely use for your communication?

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* 12. Can you provide an example(s) (roadmap) of a successful public awareness campaign or communication campaign?

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* 13. Does your work involve post-approval pregnancy and/or lactation studies, including registries or pregnancy surveillance programs (PSPs)?

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* 14. If yes, what type of study was this?

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* 15. What limitations or opportunities were presented by the study design(s)?

Questions 16-18 pertain to the PRGLAC Task Force Work Group on Drug Development.

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* 16. To improve involvement in research that will lead to development of therapies for harmful health conditions during pregnancy or lactation, what incentives, policies, and/or protections would need to be in place to motivate investigators or companies to undertake these studies?

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* 17. What data linkage processes/projects do you use to enhance or support research on conditions or exposures in pregnancy and lactation (e.g., linkages to birth defect registries, birth certificates, medical records, etc.)?

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* 18. What funding methods do you rely upon to develop medications or conduct research on medications/conditions in pregnancy and lactation?

Questions 19-20 pertain to the European initiative, ConcePTION.

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* 19. Do you work with the European initiative, ConcePTION? 

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* 20. If yes, what is your involvement:

Thank you for completing this survey.

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