Name: Michael Hamilton
Province you live in: British Columbia
How many clinical trials have you participated in: 3
Describe yourself in one word: Advocate
Please introduce yourself:
I am 32 years old living with CF. I was diagnosed at 12 years of age at BC Children’s Hospital, I am heterozygous deltaF508, and I am currently working on my Ph.D. at Simon Fraser University. My research is focused on trying to better understand the mechanisms of action of the new CFTR modulators. I have participated in many advocacy and fundraising activities for Cystic Fibrosis Canada, including GearUp4CF, the Rod Brind’amour & Nugent-Hopkins Golf Classic, and Shinerama. I am currently a community member of the recently formed CF Canada Accelerating Clinical Trials (CF CanACT) Network which aims to increase access and awareness for CF patients to participate in clinical trials across Canada.
Please share your clinical trial experience:
I have participated in a few clinical trials over the years, as well as multiple investigator studies at St. Paul’s hospital, and they have mostly been a positive experience. My journey with participating in clinical trials started a few years ago with a phase II study of a CFTR modulator that was not approved for my indication (one copy of deltaF508-CFTR). I remember it was quite exciting to get onto a trial for a modulator as I had been paying attention to the research of ivacaftor and lumacaftor, and I wanted to experience the results that others were having. Unfortunately after a few months of collecting data they discontinued the trial due to “futility”, this was difficult emotionally, as you want the drugs to work. Every time you see even the slightest positive change you want to attribute it to the drug and to be told you have to stop was difficult.
Luckily a few years later I was able to get onto the phase III trial for Trikafta, and thankfully this time there was no doubt about its efficacy. Within days, I experienced significant effects that I hadn’t experienced before, it was pretty obvious I wasn’t on placebo. By the end of the month I was no longer coughing, I was fat, and I could sleep through the night. I could laugh without going into a coughing fit, and for the first time in my life I got a regular person cold that didn’t turn into an opportunistic infection or exacerbation. My FEV1 jumped from around 80% to over 90% (from my regular clinic visits). To say this drug has changed my life is an understatement. Most days I wake up, take my pills and don’t even think about my breathing or my health. I just exist and do regular people things. I can run and play soccer and never go into a coughing fit. I’m having to consider what I actually want to do for my career because it’s looking like I’ll be able to have one.
None of this would have been possible without participating in a clinical trial and taking that chance to be a research subject. Sometimes it doesn’t pan out, and for a lot of years the rewards were only slightly beneficial, but this time I got lucky and it was worthwhile. The drugs going through clinical trials are usually at the forefront of medicine, and taking the chance to experience their effects can definitely outweigh the risks. The other benefit is that you will be helping others; your contribution will help prove that the drugs are safe and effective and others will be able to benefit from that, particularly those who aren’t healthy enough to participate.
Now the question just becomes one of access to medication, this is the only question I have left about participating in clinical trials, and its uncharted ground for me, as I’ve not been part of a successful trial before. The open label part of the trial I am on will end this fall, and currently Trikafta hasn’t even been submitted for approval in Canada, so my only question is what happens when the trial is over. I know in the past when my mother participated in cancer clinical trials she was able to get access to the drug after the trial, but the consent form specifically said they did not need to provide the drug once the trial concluded. I’m hoping that ethically they can’t halt treatment as they have data for me specifically showing efficacy, and the doctors say they probably won’t stop, but that assurance isn’t in writing yet. Either way, I have so far been able to have the best two years of my adult life and I am very glad I was willing to take the chance to participate in new research.