Module232025

07/05/2025

HD0

Some Clinical Trial Challenges

1. How many subjects are in the trial?, assuming a single foetus One? Two? Not one but not two? More? 2. Paternal rights or interests 3. Foetal “rights” – including safety 4. Maternal “rights”

5. Paternal “interests” 6. Pregnant partners

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How many participants are in the trial? (1)

• Unless the placenta provides an ABSOLUTE barrier to a drug, the foetus will be exposed to the drug. even if that IS the case, the foetus may be exposed to the consequences of the drug – reduced blood sugar, reduced blood pressure, etc. • Art. 33(a) of the CTR requires “direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth”. the use of the possessive ‘her’ might suggest that the embryo, foetus and child after birth are not considered to be research participants in their own right, but derivatively from the pregnant woman. • A ‘one-patient’ model is not easily applicable to trials in pregnant women which may result in foetal exposure to the drug or its effects.

• A ‘two-patient’ model doesn’t work either – the foetus cannot be an independent trial participant

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