In post-Roe US, clinical trials may be too risky during pregnancy

In an op-ed last year in Stat, Aoife Brennan, the CEO of a Massachusetts-based company developing treatments for metabolic and immune-based diseases, described the situation of a 32-year-old woman who was participating in a Phase 1 trial. She tested negative for pregnancy at enrollment and agreed to use contraception. Still, when she checked in for the second phase of the trial, she tested positive. A visit to her OB-GYN revealed that she had a spontaneous abortion, in line with her history of recurrent miscarriages and irregular menstrual cycles. At the time, the only consequence was that she was disqualified from the rest of the trial. But, “Post-Dobbs, and in a different state, she might now be suspected of a criminal act,” Brennan wrote.

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