Operationalizing Inclusion

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Presentation transcript:

Operationalizing Inclusion George Saade, MD Professor, OB-GYN and Cell Biology Chief of Obstetrics and Maternal-Fetal Medicine Director, Perinatal Research Division The University of Texas Medical Branch Galveston, TX

Teratogenicity, while important, is not the only safety concern

Other Concerns in Pregnancy: Dosing Lack of data on dosage Physicians extrapolate drug dosage regimens from non-pregnant subjects Can lead to under or overdosing

Proportions of PK trials in pregnancy McComack & Best. Frontiers 2014

Magnesium Sulfate Many uses in pregnancy Dosing regimen Stop premature labor Prevent seizures in women with preeclampsia Protect fetal brain in infants born prematurely Dosing regimen No therapeutic level Duration

What about transmission during pregnancy and childbirth?

Drug studies in pregnancy: Additional examples Newer oral anticoagulants AED SSRI MRI and US contrast agents Asthma medications

JAMA Pediatrics April 2014 Volume 168, Number 4

What do I see? Very little evidence to guide OB practice Clinical research in pregnancy is difficult Involves mother, fetus, family Outcomes are rare Long term follow up ROI on clinical research in pregnancy Impacts mother, fetus, family Impacts long term

Cumulative Value of Gains in Longevity by Age in Males Murphy & Topel 2004

Cumulative Value of Gains in Longevity by Age in Males Highest at birth Murphy & Topel 2004

Cumulative Value of Gains in Longevity by Age in Females Highest at birth Murphy & Topel 2004

Cumulative Value of Gains in Longevity by Age in Females Reproductive age in women is another area Murphy & Topel 2004

Cumulative Value of Gains in Longevity by Age in Females Reproductive age in women is another area Murphy & Topel 2004

Economic Value of the War on Cancer Lakdawalla et al. 2010 In Year 2006 dollars

A War on Obstetrical Complications is Needed

Am J Obstet Gynecol 2013;209:150.e1-6.

Ehrhardt et al. JAMA 2015;314:2566-7

Ehrhardt et al. JAMA 2015;314:2566-7

Ehrhardt et al. JAMA 2015;314:2566-7

Burden in Pregnancy Regulatory Paternalistic attitudes (“vulnerability”) Lukewarm interest from industry Reliance on governmental funding Limited researchers

Burden in Pregnancy Overemphasize risk to fetus & underemphasize risk of lack of evidence Burden of IND and IDE in pregnancy IRBs’ limited expertise in pregnancy No good in-vivo model of placenta Reporting of adverse events

Impact Discouraging physician scientists Using treatments and interventions without evidence Preterm birth remains a problem Rising maternal mortality and morbidity Health disparity

Burden of Tocolytic Trials Dose finding studies Inclusion criteria different from clinical practice Placebo Long term outcome Two confirmatory trials

Burden of Prevention of Postpartum Hemorrhage IND Wait until cord clamping Breastfeeding Neonatal examination Creeping clinical practice

What is Needed to Increase Inclusion of Pregnant Women Better federal funding Support research networks Increase length of follow up Track clinical trials Incentivize industry Economic Medico-legal Decrease burden of research in pregnancy Central IRB More measured regulation Promote comparative effectiveness and group-randomized trials

If we knew what we were doing, it would not be called research, would it?