Clinical Trials: On Information and Luck

During a recent clinic visit and conversation with my son’s doctor, I mentioned our desire to have a CT scan performed to assess disease progression in his airways. It had been almost 18 months since our last scan, and it’s important for us to know how his cystic fibrosis (CF) is progressing in light of the different treatments and therapies that we use in an effort to slow that progress. In response, she mentioned a research study that uses both CT scan and MRI imaging to identify disease progression in people with CF and asked if it was something we might be interested in learning more about. Naturally, I said yes! On my way home, I started to think about how lucky I was that my doctor knew about that study. I wish that we could design a way for people and important information to intersect more seamlessly, without relying on luck.

Considering Participation

A few days later I received a phone call from the study coordinator who wanted to tell me a little bit more about the study, see whether we met the inclusion criteria, and if we did, whether it was something that we would be interested in participating in. She reviewed the protocol, told me about what they were hoping to learn and made me aware of the risks. I should tell you that I was walking into school to pick up my kids when she called (because life doesn’t pause for health care concerns), so as she started to review the visits and what each entailed over the course of the next 12 months, it became more information than I could take down at that time. It sounded good, and so when we neared the end of the conversation and she asked, “How does this sound?” I said, “Great!” and we agreed to connect over email. 

As the day progressed, I realized that I wasn’t really sure what I had verbally agreed to. The things I heard included that he would have a CT scan and an MRI, he would need to come into clinic for a visit, or maybe two, that would be three to four hours long, and that one or some of those things would be repeated in about 12 months. The next day when I had some time to sit down with a pen and paper, I called her back and asked if we could go through the details again. She went through the study protocol, including what needed to happen and in what order and time frame, answered my questions about flexibility with any of those appointments and asked questions to better understand my priorities and concerns. 

When I’d had a moment to reflect after our first conversation, I realized that this sounded like a pretty big time commitment, and while it wouldn’t likely be a problem for me, I had to consider how it would interfere with Drew’s life. He hates missing school, and I hate for him to miss it. How long would these appointments be? Could we break them down into smaller chunks or did it require us spending an entire day at the hospital? Was there a way that we could integrate this into his regular care visits so that additional trips to the hospital weren’t required? With my concerns addressed and the study team being appropriately accommodating, we agreed to participate. Our first visit is scheduled for mid-February.

Making it Better

I started to think about how valuable it would be in situations like these to have a tool like Trial Visit Overview—I had gotten a look at it not long before Leigh Anne’s recent blog post was published. What would have helped was to have a place where I could go to get simplified and specific information, high level details about what would happen during the course of this study. Having this information in a visual form and not just explained over the phone would enable me to make informed decisions about whether or not this would be the right trial for me.

Clinical trials are a critically important part of health care improvement. It’s not more information that will help people to be better informed, but rather the right information, organized and presented in a way that makes sense to them. While Trial Visit Overview doesn’t quite crack the nut on raising awareness of the importance of clinical trial participation, it does support the people who have decided, in one way or another, that participating in a clinical trial might be right for them. It allows you to see the comprehensive picture of what participation means, on a visit by visit basis, beyond the risks and benefits, into the implication of participation in your everyday life.

While recruitment tends to be a success metric in clinical research, I’d like to suggest that perhaps what we need more than just filling up clinical trials is sustained and complete participation in them. 

I think that a lot of people sign up for studies without really understanding what’s required of them for participation, as I did with my son and the CT study. Informed participation, theoretically at least, would mean fewer people drop out of studies when they realize at some point in the course of their participation that they can no longer commit to the regimen that perhaps wasn’t so clearly laid out at the start of the trial. We need to get the right people into the right trials so that we can get the right drugs to the right people, faster. I think that Trial Visit Overview has the potential to help.

Clinical trials are just one part of a complicated journey that people who are living with a disease or new diagnosis are expected to become aware of, figure out how to navigate and then change their lives to participate in. Any resources that make that journey less bumpy get two thumbs up from me.