BOX 2-4Task Force on Research Specific to Pregnant Women and Lactating Women Report Recommendations

1.

Include and integrate pregnant women and lactating women in the clinical research agenda

2.

Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women

3.

Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics

4.

Remove regulatory barriers to research in pregnant women

5.

Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women

6.

Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women

7.

Develop separate programs to study therapeutic products used off-patent in pregnant women and lactating women using the National Institute of Health (NIH) Best Pharmaceuticals for Children Act (BPCA) as a model

8.

Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women

9.

Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research

10.

Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women

11.

Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women

12.

Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women

13.

Optimize registries for pregnancy and lactation

14.

The Department of Health and Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019

15.

Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research

SOURCE: NIH, 2018b.