Childbearing vs. clinical trial participation: is it one or the other?

Abstract

Recent advances have shed light on the importance of early therapeutic intervention for neurodegenerative diseases. Primary prevention trials present a potential disease-modifying strategy for pre-symptomatic patients of autosomal dominant neurodegenerative diseases (ADND), such as early onset familial Alzheimer’s disease (AD) and Huntington’s disease (HD). As trials target earlier disease stages, however, prospective participants face new ethical and logistical challenges, namely childbearing and reproductive health decisions. Since pregnancy is an exclusion criteria for such trials, participants of reproductive age must choose between participating in research and having a family. Such decisions carry significant burdens for ADND patients that if left unaddressed could impact patient well-being and the field as whole. We use our perspective as scientists, advocates, and ADND family members to highlight current shortcomings in the field regarding trial participation and family planning issues for ADND patients and call for the establishment of a normative standard to address these concerns.