Rachel: In your experience in the drug trials that you’ve been involved with, over 40, do you remember the percentage of women versus men involved and was gender discussed?
Prof. Carolyn Young, Consultant Neurologist: So, it hasn’t been discussed in the scientific committees following on because we have usually had a pretty clear signal that other than, I can think of perhaps two studies, men and women are behaving the same. What is becoming more of a topic of concern is whether recruiting in different countries is potentially warping some of our end points.
The representativeness of the trial population to the overall treated population, the true scientific concern is not so much the male/female, it’s that a lot of trials put an upper age limit, but in real life people over that age limit wish to be able to access these drugs and to try and unravel whether the upper age limit is a matter of convenience or is a matter of de-escalating risk or of avoiding futility, has been extremely difficult to determine.
So I fear that there may be some medications coming through that do not work as well, depending on certain characteristics like your age, but you, as a clinician, as a patient, to try and find that out, to personalise it to your own particular age, very difficult.
Rachel: Just out of curiosity, what is the usual upper age, where you find there’s less trials?
Prof. Carolyn Young: So, to my amusement, you might be considered too elderly at 55 or 50. And you have to be an adult to go in. So the age range looks great if it’s 18 to 50, but actually when you template that against the time that people get the disease and how long they live with it, it really doesn’t match at all.