The Supreme Court’s decision to overturn Roe v. Wade opened the door to allow states to ban or severely restrict abortion. But as biotech CEO Aoife Brennan and her colleagues are coming to realize, it will also affect how — and perhaps where — clinical trials are conducted.
Pregnancy tests are an important, and sometimes required, part of clinical research, a way to ensure that an experimental drug does not harm a fetus. If a participant in a clinical trial becomes pregnant, that information is recorded and the researchers are required to follow up with the participant to understand if the drug affected the pregnancy. It’s a simple process, but one that will be immensely complicated by the court’s Dobbs decision.
This week on the “First Opinion Podcast,” Brennan, the CEO of Cambridge, Mass.-based Synlogic, talks about how the Supreme Court’s ruling is forcing people involved in clinical research to rethink something as simple as pregnancy tests, which had once been taken for granted, and plan for the possibility that research sponsors and study sites will be required to share pregnancy and outcome data with state officials.
“It’s important to start a conversation around how we’re going to navigate continuing to enroll diverse clinical trials,” Brennan said. “I don’t know what obligations we will have in terms of having to disclose information.”
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