Only approximately 3% of adult cancer patients participate in clinical trials.
In a 2010 analysis of more than 400 National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials, 37.9% failed to attain the minimum accrual goals, and 70.8% of phase 3 trials had poor accrual.
It's really slowing the field down; it's not a burden, but it's slowing it down. We are not able to generate new therapies and new therapeutic strategies. We are condemning ourselves to being stuck where we are right now, which is that most patients are not cured of their cancer. Patients are living longer and more patients are being cured. But if we maintain the status quo, we are not going to be any better, and that is a very, very depressing thought to think -- that 20 years from now we will be doing the same thing we are doing today. We need research and no one wants to see that. I think you have to look beyond that and say, why is only 3% of the population going on trials? What is the barrier? And there are many.
A lot of the studies, the phase 3 studies, are large, costly, and take a long time to do. Many of them have never completed their enrollment. There is a sense that we need a research enterprise that is much more nimble and faster; if our studies are going to fail, we want to find out early on that they are not working and stop the study and go on to some other idea. We don't want to invest 10 years and millions of dollars in an eventually failed trial. So I think there is a greater appreciation for the need to do more phase 1 and phase 2 studies, and less complicated phase 3 studies, in order to complete these trials quicker, and to also make the trials more attractive to patients to enroll in. Efforts to redesign the cooperative group structure are trying to move away from large phase 3 trials; whether that is the right answer or not, I'm still waiting to see. I think that the cuts have gone too far, so I don't want it to be said that I approve of the cuts, but I think that part of the reason for the cuts is because we essentially need to do trials faster.
The other issue is, in the world of big data, can we learn from the patients who aren't on trials? That large resource of 97% who are not on studies is really a source of big data that we can derive a lot of learning from, and that has been the impetus for CancerLinQ, which is ASCO's big data initiative. I'm starting to call it "shrinking big data."
We're not enrolling enough patients in trials and we have so many trials that aren't accruing. Honestly, I think we've got to rethink the way we do research in a big way. Traditionally we've done step-wise research from phase 1 to phase 2 to phase 3 and had lots of different centers duplicating efforts. We're going to have to streamline that, and we're going to have to think about doing research in a faster way without having so many phases of treatment.
The biggest challenge in the community right now has been the reorganization at the National Cancer Institute with the [NCI Community Oncology Research Program] formation. We've been challenged with that in trying to decide who we align with, who can provide us with the most relevant trials for our patients in our community. You're also a bit at the mercy of the cooperative groups in terms of what trials they design and whether those trials meet your patients' needs.
It's much harder in a smaller community to engage with pharmaceutical companies to do that type of research, but we're trying to do that too because you can bring more cutting-edge trials to your patients that way.
It is a major problem and one that a lot of ACCC members look very closely at and try to address. But it is difficult because clinical trials often are a loss leader, for lack of a better term, in many practices. I think a lot of it is resource-based, the fact that resources really aren't available to spend on a lot of these trials. [Community physicians], for the most part, want to do them. It is not that they don't want to participate in clinical trials, but it comes down to the dollars and cents at the end of the day, and it is definitely problematic.