Draft guidance urges inclusion of pregnant and breastfeeding patients in drug trials
Pregnant and breastfeeding patients are often excluded from clinical trials. A new draft international guidance aims to address this gap in evidence.
This affects pregnant and breastfeeding individuals; the evidence is based on current research practices and proposed guidelines.
current trial practices
Pregnant and breastfeeding patients are routinely excluded from clinical trials, leading to a lack of evidence on drug safety and effectiveness for these groups.
guidance proposal
The draft international guidance seeks to ensure that pregnant and breastfeeding individuals are included in future drug trials to improve medical evidence for these populations.
Common questions
Why are pregnant and breastfeeding patients excluded from trials?
They are often excluded due to concerns about potential risks to the fetus or infant, leading to a gap in evidence for these groups.
What does the draft guidance propose?
The guidance proposes including pregnant and breastfeeding individuals in clinical trials to generate more accurate and relevant medical evidence.
Sources
- Drug Trials Must Address Pregnancy Evidence Gap Medscape · medscape.com
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