Evidence-based pregnancy testing in clinical trials: Recommendations from a multi-stakeholder development process

• Published in: PloS one Vol. 13; no. 9; p. e0202474
• Main Authors: Morse, Jessica E., Calvert, Sara B., Jurkowski, Claire, Tassinari, Melissa, Sewell, Catherine A., Myers, Evan R.
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 12.09.2018; Public Library of Science (PLoS)
• Subjects: Analysis; Biology and Life Sciences; Birth control; Chorionic Gonadotropin - analysis; Chorionic Gonadotropin - blood; Chorionic Gonadotropin - urine; Clinical trials; Cost assessments; Embryos; Ethics; Evidence-based medicine; Evidence-Based Practice - methods; Exposure; False Negative Reactions; Female; Fetuses; Food; Genetic transformation; Guidelines as Topic; Gynecology; Health aspects; Humans; Identification methods; Internet; Medical research; Medicine and Health Sciences; Obstetrics; Pregnancy; Pregnancy complications; Pregnancy Tests - methods; Pregnant women; Prenatal exposure; Research and Analysis Methods; Researchers; Risk factors; Risk reduction; Social Sciences; Studies; Surveys and Questionnaires; Transformation; Urine; Womens health; North Carolina; United States > US; Maryland
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0202474

Most clinical trials exclude pregnant women in order to avoid the possibility of adverse embryonic and/or fetal effects. Currently, there are no evidence-based guidelines regarding appropriate methods for identifying early pregnancy among research subjects. This lack of guidance results in wide variation in pregnancy testing plans, leading to the potential for inadequate protection against embryonic or fetal exposure in some cases and unnecessary burdens on research participants in others, as well as inefficiencies caused by disagreements among sponsors, investigators, and regulators. To address this issue, the Clinical Trials Transformation Initiative convened content experts and stakeholders to develop recommendations for pregnancy testing in clinical research based on currently available evidence. Recommendations included: 1) the study protocol should clearly state the rationale for pregnancy testing and the plan for handling positive and indeterminate tests; 2) protocols should include an assessment of the pregnancy testing plan advantages (reduced risk of embryo/fetal exposure) versus the burdens (participant burden, study team workload, costs); 3) protocols should assess the participant burdens regarding the likelihood of false negative and false positive results; 4) participant administered home pregnancy testing should be avoided in clinical trials; and 5) the consent process should describe the extent of knowledge about the study intervention's potential risk to the embryo/fetus and the limitations and consequences of pregnancy testing. CTTI has also developed an online tool to help implement these recommendations.