Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials.

ABSTRACT: Clinical trials to address the COVID-19 public health emergency have broadly excluded pregnant people from participation, illustrating a long-standing trend of clinical trial exclusion that has led to a clear knowledge gap and unmet need in the treatment and prevention of medical conditions experienced during pregnancy and of pregnancy-related conditions. Drugs (includes products such as drugs, biologics, biosimilars and vaccines) approved for a certain medical condition in adults are also approved for use in pregnant adults with the same medical condition, unless contraindicated for use in pregnancy. However, there are limited pregnancy-specific data on risks and benefits of drugs in pregnant people, despite their approval for all adults. The United States Food and Drug Administration-app

SUBMITTER: Sewell CA 

PROVIDER: S-EPMC9351207 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature