CTs for Pregnant & Lactating Women

21st Century Cures Act established the “Task Force on Research Specific to Pregnant and Lactating Women” (PRGLAC) to provide guidance to the Secretary of HHS. The Task Force will study knowledge gaps in federal research regarding safe and effective therapies for this group of women when included in clinical trials.

Federal members of PRGLAC include the National Institute of Child Health and Human Development (NICHD) https://www.nichd.nih.gov, CDC https://www.cdc.gov, National  Office on Women’s Health https://www.womenshealth.gov, National Vaccine Program Office https://www.hhs.gov/nvpo/index.htm, AHRQ https://www.ahrq.gov,  Health Resources and Services Administration (HRSA) https://www.hrsa.gov, as well as FDA https://www.fda,gov, VA https://www.va.gov, and the Department of Defense https://www.defense.gov.

Francis S. Collins MD, PhD, Director of NIH https://www.nih.gov, appearing before the Senate Committee on Health, Education, Labor, and Pensions https://www.help.senate.gov last December, described how discussions are taking place at NIH related to clinical trials since special consideration is needed to address specific populations when conducting trials.

The topic on inclusion and exclusion in clinical trials was discussed in-depth at the public workshop “Evaluating Inclusion and Exclusion Criteria in Clinical Trials” held April 16, 2018. The one day workshop sponsored by the Duke Margolis Center and led by Mark McClellan, Director of the Duke Margolis Center for Health Policy took place at the National Press Club.

The issue related to inclusion and exclusion needs to be considered when initiating clinical trials where special populations will be included such as in the case of the elderly, children, infants, adolescents, patients with organ dysfunction in phase III trials, and pregnant and lactating women.

The problem is that the safety, efficacy, and the doses of medications used and approved for the general population may not apply to special populations and especially for pregnant or nursing women. Also, there are safety considerations that need to be discussed for the developing fetus or newborn when the mother-to-be or the mother nursing is participating in a trial.

According to the experts in the field, pregnancy can sometimes change how drugs are metabolized and cleared, which can alter the dose needed to treat a condition. Pregnancy-related conditions can also affect the health of a mother or newborn long after delivery so more research is needed to develop new drugs to treat pregnancy-related conditions.

Catherine Spong, Deputy Director for NICHD reporting on PRGLAC and their activities related to the needs of pregnant women and nursing mothers at the workshop explained, “When clinical studies omit pregnant women and nursing mothers then healthcare providers are left without evidence-based research to inform care decisions”.

She said, “Without this research, treatment of pregnant or nursing mothers who experience common medical conditions may not be effective and even potentially cause harm. Therapies for pregnant and lactating women ideally should have the best available evidence, given the implications for the developing fetus and newborn.”

PRGLAC is now reviewing current research on pregnancy and lactation along with identifying ethical issues surrounding the inclusion of pregnant women and nursing mothers in clinical research. The Task Force is currently discussing federal activities focusing on specific drugs, formulations, and other pharmacological factors that may affect health outcomes for this group of women.

In further progress, a series of Task Force meetings were held to address the needs of pregnant and lactating women last August and November, and also in February 2018 with the last meeting scheduled to take place May 14-15, 2018.

NIH published an RFI on this subject February 15, 2018 with responses requested by April 2, 2018. The RFI was seeking input from the wider scientific community and the public on how NIH should proceed. Go to https://grants.nih.gov/grants/guide/notice-files/NOT-HD-18-003.html for details on NIH’s interest

This month the Center for Drug Evaluation and Research at FDA, released a draft guidance document titled, “Pregnant Women, Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry”. For more information email druginfo@fda.hhs.gov.

Go to https://www.nichd.nih.gov/about/advisory/PRGLAC for more information on the PRGLAC Task Force.