Module232025

07/05/2025

Vulnerable subject commonalities under CTR

Requirement

✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

Legal representative permission required

*

N ✓ ✓ N N N N N N

✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

Subject given information according to capacity to understand Explicit wish to refuse participation in / withdraw from trial is respected

No financial incentives to subject or legal representative

Data of comparable validity cannot be obtained from trials in other persons Trial relates directly to a condition from which the subject suffers Prospect of benefit for the population the subject represents Prospect of direct benefit to the subject outweighs the risks involved Trial poses minimal risk to and imposes minimal burden on subject

Why are pregnant women considered to be similar to incapacitated adults and minors, but different to men and non-pregnant women groups? Foetal personhood?

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The pregnant partner is NOT a trial participant

Phase II/III trialists share common characteristics: • have a disease or condition the IMP is intended to treat; • satisfy selection criteria intended to enable the selection of a reasonably homogeneous group of participants to support the efficacy assessment whilst ensuring participant safety; • have been provided with information relating to the IMP and the study, and given consent prior to protocol-defined procedures being undertaken, including IMP administration; • take or receive a protocol-defined dose of the IMP, according to a protocol-defined treatment regimen, for a protocol-defined period of time; • are under the care of a senior physician specialising in the target condition; • are the intended recipients of the IMP.

The pregnant partner:

may not been told by her partner that he is in a clinical trial ➢ male participant may not wish to do so and is under no legal obligation to do so, e.g., Viagra is under no obligation to provide data regarding the pregnancy or its outcome to the trial sponsor.

•

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