Engaging Patients in Oncology Trials Is a Team Effort

Joseph Alvarnas, MD: It does make all of this much more complex, which begs the questions: How do we educate patients, or referring physicians, in order to improve recruitment, and who can help us? Are advocacy groups an important adjunct to that educational process? Are there others who can help us foster that learning that you talked about? How do we move this forward in a meaningful and engaging way?

John Fox, MD: Yes, that’s a tough question—specifically about enrolling in clinical trials. I think one of the things that we have to do is figure out how to make it more affordable and even more accessible. I know that one of the large cancer centers in Boston is trying to push cancer clinical trials out into the community to make sure that patients can get access to trials with their local physicians under the guidance of the mothership. I think the biggest problem in our area in enrolling patients in clinical trials is that they have to travel.

Joseph Alvarnas, MD: And for us, part of what we’ve done is develop a network of 15 enrolling community-based practices where we can offer these trials. I live in an area where there are 127 different spoken languages, and among the top 5 are Armenian, Vietnamese, and Tagalog. So, making sure that the materials are available in a format that patients can actually appreciate and understand so they can move forward is tough to navigate, but it’s part of the cost of doing that business.

Robert Carlson, MD: One of the challenges is, and I think we’ll talk about it in a minute, the NCI-MATCH trial. That’s a trial that’s active at the institution where I see patients. There are 30 arms to that trial. This last week, within a 15-minute time span, I got, in my email, 60 different documents to review relating to the MATCH trial. I am supposed to be required to be intimately knowledgeable in all of those different documents for 30 different arms of a trial. That’s a huge barrier. And my response to that was to take my name off the list of investigators, because I cannot legitimately maintain that sort of expertise and knowledge on 30 different arms—realizing that the arms in that trial come and go.

So, one of the things that I think that the regulatory environment needs to start to understand is that the clinical investigation, in today’s medical world in the United States, is a team sport. There is no one who can know everything, but somebody needs to know a lot about different things so that the whole field is covered. It’s an unrealistic expectation that a single individual can do that. That’s probably a very strong lesson from the TAPUR trial and the MATCH trial—that it’s a team sport, and we need to recognize that, and empower people other than the principal investigator at each institution, to really be able to inform patients and to do some of the different regulatory activities.

Joseph Alvarnas, MD: You’ve asked an important question, which is how do we manage through the complexity of all this? The NCI-MATCH trial is one in which patients whose tumors have not responded or proven refractory to the therapeutic intervention are evaluated for existing mutations from biopsies and matched to what could be many, many trial arms. Do you see that as an advantage or a disadvantage of the trial? You’ve talked about a clear disadvantage, which is that it creates a very, very complex, paper-heavy experience of trying to figure out, as an investigator, how this works. Is the flip side—by having that level of specificity—that you might learn something about a specific population of patients? Are there advantages to this trial design, or is it just a lot of complexity and paperwork? I’m looking at both of you.

Robert Carlson, MD: From my perspective, it’s all of the above. We’re learning how to do these multiple, multiple arm trials. It’s very complex, but we have multiple, multiple arms because there are highly specific populations that we’re targeting for those trials. And so, I think we will learn more about those specific small populations, but it’s much more complicated in order to be able to do that. Again, because the sample sizes are going to be smaller, the confidence that the result is a true result is going to be lower, and we’re going to have to recognize that and figure out ways to correct for that if we make the wrong inference from the data that we have.

John Fox, MD: From my vantage point, I’m not an expert in making sausage. We’ve got very competent people who are. I want to make sure, at the end of the day, that the sausage is high-quality sausage, and I have to rely on people other than health plan medical directors to provide insight on that.