Walking the walk to include pregnant participants in non-obstetric clinical trials: Insights from the SNAP Trial

Despite several calls for greater inclusion of pregnant people in non-obstetric clinical trials, their systematic exclusion remains common practice. Excluding pregnant individuals from clinical trials may result in unintended consequences such as inadequate treatment of medical conditions in pregnancy, inappropriate dosing of medications, and investigational therapies being used off-label outside of the context of a clinical trial, risking adverse events in the absence of demonstrated efficacy.

Citation:
Malhamé I, Hardy E, Cheng MP, Tong SYC, Bowen AC. Walking the walk to include pregnant participants in non-obstetric clinical trials: Insights from the SNAP Trial. Obstetric Med. 2023;16(1):3-4

Keywords:
Asthma Australia; James Lind Alliance; asthma; consumer; end-user; engagement; research priority setting

Abstract:
Despite several calls for greater inclusion of pregnant people in non-obstetric clinical trials, their systematic exclusion remains common practice. Excluding pregnant individuals from clinical trials may result in unintended consequences such as inadequate treatment of medical conditions in pregnancy, inappropriate dosing of medications, and investigational therapies being used off-label outside of the context of a clinical trial, risking adverse events in the absence of demonstrated efficacy.