Pregnancy and Protection: the Ethics of Limiting a Pregnant Woman’s Participation in Clinical Trials

Abstract

The call for the inclusion of pregnant women in clinical trials has received renewed attention recently. This interest springs from articles in various medical journals highlighting the gaps in medical knowledge and the need to improve health care for pregnant women. It is not a simple decision whether to include pregnant women in studies or not. The general thought is that it’s too dangerous for the baby if a pregnant woman is participating in a trial, and the absence of research on how medications work in pregnant women leave doctors guessing about how to safely and effectively treat patients through pregnancy. Excluding pregnant women from clinical trials are not automatic, not unethical nor is it arbitrarily determined. The regulatory framework is based on sound ethical and legal reasoning that demonstrates when inclusion in a clinical trial is appropriate or when clear and compelling reasons for exclusion are presented. Learning objective Readers will learn about limitations of research, history of the inclusion and exclusion of pregnant women in clinical trials, reticence for inclusions, as well as regulations designed using reasoned legal and ethical principles, such as: Principle of Autonomy, Informed Consent, and Beneficence and Nonmaleficence.

Outcome of pregnancies in women receiving velaglucerase alfa for Gaucher disease

“…In fact, three of four child‐bearing female patients who had participated in the seminal clinical trial decided to initiate a pregnancy during the extension of the trial despite the onus involved in that choice. Whereas this is an issue fraught with ethical and legal considerations, in the case of ERT for Gaucher disease where there is long‐term experience with ERT in pregnancy, deferring family planning in females (and males) who are of child‐bearing potential but are otherwise good candidates for clinical trials, decreases the pool of eligible patients and also denies these young patients access to potentially ameliorative treatment.…”

Group B Streptococcus vaccine development: present status and future considerations, with emphasis on perspectives for low and middle income countries

“…There is no regulatory or ethical prohibition on studies in pregnancy 317 – 319 . However, the concept of maternal vaccination, which may potentially pose harm to both the mother and the infant, may not be well received in countries where uptake of vaccines currently recommended for pregnant women by WHO is low 320 .…”

An exploration of women's experience of taking part in a randomized controlled trial of a diagnostic test during pregnancy: A qualitative study

“…A randomized controlled trial (RCT) is regarded as the gold standard when testing efficacy of any new drug, intervention or diagnostic test . The use of drugs such as thalidomide and diethylstilbestrol in pregnant women has had long‐lasting repercussions, with women of childbearing age traditionally being excluded from clinical trials owing to safety concerns and fear of litigation . Nevertheless, up to 74% of pregnant women take at least one mediation for chronic or acute conditions while the use of prescription medications by pregnant women has risen by more than 60% over the last three decades, with most of these drugs being used off‐label .…”