Washington, DC—Patient involvement in clinical trials will impact the Cancer Moonshot’s goal of achieving 10 years of progress in 5 years’ time, said Kim Thiboldeaux, Chief Executive Officer, Cancer Support Community, Washington, DC, at the Sixth Annual Conference of the Association for Value-Based Cancer Care.
“Getting it done isn’t just going to take the best and brightest across the medical research and data community, but millions of Americans owning a stake in it,” Ms Thiboldeaux said.
In June 2016, the Cancer Support Community was invited to participate in the Cancer Moonshot summit that was hosted by Vice President Joe Biden.
Patient Enrollment Key to Innovation
The Patient Education Program, of the Cancer Support Community, collaborated with 20 organizations to develop a national program on clinical trials for patients with cancer, drawing the attention of the Cancer Moonshot summit.
“We can have all of this conversation about moving the science forward in innovation, but it is not going to happen without the patients,” Ms Thiboldeaux said. “As many of you know, right now only 3% of adult patients with cancer participate in clinical trials, where the data show that about 25% of patients with cancer likely qualify for participation in a trial.”
Using quantitative and qualitative research about patients’ perceptions of clinical trials, the Patient Education Program found that the majority of patients often choose not to participate in a clinical trial because they fear receiving the placebo instead of the active drug.
Providing evidence-based information to patients when they are making treatment decisions can have a significant impact, said Ms Thiboldeaux. A study conducted by the Cancer Support Community showed that after 1 counseling session, 9% of the patients enrolled in a clinical trial, a significant increase compared with the national average of 3% patient participation.
“When I look out at all of the time and money and energy we’re spending to try to recruit patients into clinical trials, there are actually some pretty simple, low-cost, scalable ways that we can educate patients about clinical trials, help to dispel the myths and misconceptions that patients hold about trials, and encourage that enrollment and engagement,” she said.
Another important aspect of the Patient Education Program is that it only costs approximately $50 for one 45-minute session, said Ms Thiboldeaux, so the cost is not prohibitive.
As with nearly every facet of healthcare, the financial burden placed on patients who are interested in participating in clinical trials is growing.
The copayments for tests and scans are increasing, and because the majority of insurance companies will only pay for an allotted number of these procedures, patients enrolled in clinical trials who require additional tests or scans are left with paying the copayments.
“The truth of the matter is that copay was established many years ago, so that you would have to pay $5 on your $25 antibiotic. That’s why copay was established. It was that you had some skin in the game on getting your medication,” Ms Thiboldeaux said. “We never envisioned that patients would have $100,000 therapy, and they have a 20% copay. A $20,000 bill is going to wipe out most American families.”
Although many copay assistance programs are available to patients today, these are a “Band-Aid on a problem,” and the root of the issue of high costs has to be addressed, said Ms Thiboldeaux.
The Role of Big Data
Even if patients decide to participate in clinical trials, several barriers to clinical trial participation remain, including matching a patient to an appropriate clinical trial and utilizing their data. At the Cancer Moonshot summit, several recommendations focused on the potential impact of big data on patient enrollment in clinical trials. Ms Thiboldeaux discussed one recommendation to create a national database where patients can share their tumor profile information.
This database will “essentially create sort of a dating service with companies to match [patients] up to clinical trials based on genetic predisposition, based on results of biomarker tests,” she said. “That’s an idea that we really think has some legs. As we know, as clinical research develops, we’re no longer simply doing trials that are based on your disease stain. We’re doing many more trials that are based on your tumor profile and your genetic predisposition,” Ms Thiboldeaux added.
Ms Thiboldeaux hopes that the Cancer Moonshot initiative does not get pushed to the side when the current presidential administration leaves office. In an effort to keep the progress moving forward, the Cancer Support Community has partnered with several other national organizations to host a summit in June 2017. The “Cancer Moonshot: One Year Later” conference will review what has been achieved, what resources are still needed, and what barriers remain.
“With all of the change and transition that’s coming, it is incumbent upon us to keep people’s feet to the fire and keep them accountable on the work,” she said.