I think the issue of how to ethically involve children and women in clinical trials when we know or might suspect that there is a problem depends on the question you're asking. It depends on what you want to study. If what you're trying to study is an effective anti-infective for a serious infection that occurs during pregnancy, then the ethical boundary you're crossing to treat women in a clinical trial to determine its effectiveness while exposing them to a potentially risky therapy can be weighed against the potential benefits of that therapy. I think how we get around the ethical issues depends on the question, really.
Anthracyclines destroy the heart. There's a 61% mortality rate. They also cure cancer. So they're effective drugs, and we can get around the ethical issue of using them if we demonstrate that the benefit is more than the risk of the presumed toxicity.
Then there is early clinical trial monitoring. Already mandated are data safety monitoring boards to ensure that interim results are reviewed. Any safety signals that occur early in a clinical trial halt the clinical trial until further evaluation can be done. So we minimize the exposure.
There will always be a risk to using any drug in human life. There will always be risk, much like driving a car entails the risk of accidents. We can make them safer, much safer. I think understanding gender differences is important. Age-related differences are important. But I really believe that the serious effects we're talking about are largely genetically mediated, and that's where the heart of much of the science will push all of us. We'll be followers in this in the coming years.