Yesterday I was honored to speak at a session on Clinical Trials at the annual meeting of the American Society of Breast Surgeons in Dallas. Dr. Deanna Attai, the President of ASBrS and a breast surgeon I have gotten to know via social media, was very kind to invite me. Thank you Deanna!
I spoke alongside several breast cancer experts who described current and future trends in the rapidly moving field of breast cancer clinical trials. They also addressed the ways that breast surgeons not in academic medical centers can be a part of such important research.
Before the session the audience was asked the following question via an audience response system:
The correct answer is ‘a third’. It was very interesting to see that nearly 70% thought the eligibility was significantly lower, at one in ten. This suggests that there may be a surprisingly high level of acceptance in the community of the possibility that men are excluded. Nearly a quarter thought the level of access is better than it is.
My presentation started with a brief description of my personal cancer journey, but focused primarily on the observation that men are only eligible for one in three trials when looking at the breast cancer clinical trials in clinicaltrials.gov. Here are some of the key slides that I showed.
- The first explains the methodology – I downloaded trials and filtered them for breast
- The second shows at a high level the finding that men are eligible for 1/3rd of trials in the database – the blue segments of the bars which indicate trials where both genders are eligible. It is the same when you focus on trials that are currently accruing. When you focus on surgery trial it drops to one in four.
- The third slide shows the conclusions, my challenge/request to the community of breast doctors and my thanks to one of them, Dr. Beth Mittendorf, whose immunotherapy trials for breast cancer allow men to join, and one of which I was fortunate to be a part of.
Here is that challenge:
“I believe that excluding men from clinical trials for which their disease is a match should require justification in the context of established guidelines for ethical subject selection.”
In other words, if you don’t include men you have to come out and say so, and give a reason that is acceptable to medical ethicists and experts in the field. I am sure that there are many situations where that is true, but I bet there are others where men could well be included, and as a result we may learn new things about their disease and how to treat it.
Thank you again to the ASBrS for a chance to speak and to be a part of the great meeting! And thank you for all you do for patients!