The Inclusion of Pregnant Women in Clinical Research

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions. Despite some significant progress in including women in clinical research, there is a dearth of sound research data on the safety and efficacy of already approved and commonly used medications for pregnant women. At this point, nearly all medications used to treat illness in pregnant women, including common chronic conditions such as hypertension, depression, diabetes, epilepsy, and cancer, are used off-label; that is, outside of the FDA-approved uses based on clinical trial and post-marketing data. Physicians must make prescribing decisions for their pregnant patients without the benefit of randomized, controlled clinical trials testing the safety and efficacy of drugs in pregnant women or the impact of these products on the health of the fetus. This problem of prescribing in the dark is receiving some attention in the medical and scientific community, but progress appears slow. Meanwhile, pregnant women face the difficult choice between taking untested drugs or foregoing necessary pharmacotherapy during pregnancy, potentially to the detriment of both woman and fetus. The default position — to exclude pregnant women from clinical research — is untenable. Although serious challenges in study design, institutional review board (IRB) oversight, and research participant safety make the thought of research in pregnant women daunting, it is important to find ways to test commonly used drugs in pregnant patients. Postponing action until consensus on the ethical and regulatory issues can be achieved is no solution. Women get ill while pregnant or become pregnant while suffering from chronic illness, and therefore must sometimes take prescription and non-prescription medications. Researchers must, therefore, design and implement clinical trials and other types of data collection techniques for both new and already-approved drugs and therapies that will generate data for the safe use of these drugs for pregnant women and their fetuses. This article will describe the current status of inclusion of pregnant women in research, and will discuss some of the FDA-related regulatory barriers to collecting safety and efficacy information and approaches to improve the availability of data to support safe drug prescribing during pregnancy. Finally, although pro-life constituencies have significant influence on health policy, efforts to improve the quality and quantity of safety data should not bow to external, non-science-based attempts at interference with these goals