So, you are a hero and have decided to participate in a clinical trial. We all are deeply in your debt, so I want to start out and extend to you a very big thank you.
Making that decision to participate in a clinical trial isn’t an easy decision for anyone. Participating in a trial means you might be subjecting yourself to side effects, toxicities as well as possibly not receiving or delaying having the current standard of care. Participating in a clinical trial, no matter if it’s a prostate cancer clinical trial, or any other type of trial, comes with inherent and unknown risks.
There has been some recent discussions suggesting that sponsors of trials should work to reduce the risks experienced by providing long term monitoring of subjects. This is a great idea whose time has come.
Monitoring participants during the trial for side effects and results is required in trials, but once the trial has ended, in most cases, all monitoring ceases.
Most trials start out looking at subjects with late stage disease, like chemotherapy for men with castrate resistant prostate cancer. As we find additional treatments that do extend life like abiriterone (Zytiga) and enzaludamide (Xtandi) and as we move these treatment protocols to earlier stage disease as has happened, researchers need to plan to monitor study participants for much longer follow-up periods. Frankly, this isn’t happening at an adequate level!
Increasingly, patie