Clinical Trial Awareness Week 2017: Policy Roundtable Recap
Location Location Location: Advocacy Opportunities
When I moved to Arlington, Virginia to attend graduate school in the summer of 1999, I figured I’d spend my five years at Georgetown University, and after earning my PhD in tumor biology, my husband and I would move away. It seemed a fun adventure for newlyweds, but not the kind of place to settle, have a family, call home. And yet, here it is, eighteen years later, and I have the degree, but also a house, kids and a dog, and I call this place home.
There are lots of reasons I really love my home, and all of the opportunities I have as an advocate are just one reason. The FDA sponsors some fabulous workshops, there are great opportunities to learn or advocate on Capitol Hill, and I’m looking forward to some new chances to visit and learn on the NIH and NCI campus in Bethesda. But because I know not everyone has the same chance to pop over to all these cool events, I’m determined to share as I go. I try to tweet diligently at events like these, and frequently even ask questions that have been passed along to me on twitter, so follow along and share the questions you would ask if you were in the room!
— Jamie Holloway, PhD (@jamienholloway) May 3, 2017
What I Knew: Patients Need Trials!
In the past year, I’ve spent a lot more time thinking about the clinical trial than the average healthy person. I have developed a relationship with so many wonderful metastatic breast cancer (MBC) patients, and they have shared the frustration of trying to not only find a trial they think will be promising (they’re hard to find) but also one for which they are eligible (too many exclusionary criteria and washout periods that are too long). Having spent time working with the crew at Cure Forward, I have heard the stories of patients whose own health has benefitted from clinical trials — no longer are trials a last ditch treatment option that patients endure for purely altruistic reasons. Many MBC patients I know are acutely aware that their treatment options are limited. While they are fully committed to participating in research and clinical trials, hoping that they can spare future patients their grim prognosis, they are searching for their own clinical trial story — the story they can tell that will inspire others like themselves, that can bring tears to eyes like mine. They search for their own story that can dare use a word like “cure.”
What I Learned: Trials Need Patients!
With those thoughts coloring the way I think about trials, I was caught by surprise at the roundtable when it seemed that the discussion revolved around the fact that too many clinical trials never meet their accrual goals, and are forced to end without ever obtaining a complete data set. Dr. Jonca Bull, from the FDA Office of Minority Health, pointed out that an incomplete trial represents a terrible waste of resources. Not only does it waste financial resources, but it is a terrible waste of the patient’s time, experience, and data. Researchers can’t draw conclusions from an incomplete trial, and so none of the data captured has any value.
I listened as doctors discussed their own struggle to be aware of all the trials that had the potential to help patients but were only offered at other hospitals. Those same doctors lamented not having enough patients fill their own trials, and the uncertainty about how to find eligible patients at other hospitals.
I was glad to see two patient advocates on the panel as well, and they both highlighted how difficult it was, even for well-educated and highly motivated patients, to find a trial. “The burden is too big to put on a patient,” one advocate commented, and she was answered by the nodding heads of the entire panel and those attending the roundtable.
Even as an advocate well-versed in the process, I was struck by how much the doctors need to find patients to fill their trials, while the patients need to find trials to treat their disease. Yet the doctors struggle to find eligible patients and the patients struggle to find the doctor offering the right trial. They seek each other, yet successful matches are too infrequent, and when they do occur, are usually the result of exhaustive searching.
Making Policy: The Government’s Role
A policy roundtable held on Capitol Hill wouldn’t be complete without action items that can inform policy, and the panel had some solid suggestions. They proposed the formation of a public-private partnership, or a federally appointed commission, to embark on a clinical trial awareness campaign modeled after the Donate Life campaign for organ donation awareness initiated in the early 1990’s. In what I think was a pretty smart move, they even suggested that the cost for the formation of such a commission could be covered by the upcoming PDUFA reauthorization slated to happen this fall. The Prescription Drug User Fee Act permits the FDA to collect fees from drug manufacturers to fund the approval process, so this would essentially mean that the drug companies (who benefit from full, complete trials) would be the ones paying for the commission to further clinical trials awareness. The ultimate goal of the commission would be the production of a multi-media, multi-stakeholder, awareness campaign that would educate the country about the benefits — to the nation, and to some individuals — of participation in a clinical trial.
Aren’t we already aware?
I realize I’m probably preaching to the choir with this post. If you’re reading this, you’re probably already pretty aware of clinical trials and why they are important. Yet, only about 5% of cancer patients participate in a clinical trial, and in data presented at the event, the CCTA reported that nearly 40% of adults surveyed don’t understand clinical trials.
— Jamie Holloway, PhD (@jamienholloway) May 3, 2017
In fact, several panelists relayed that their own surveys and informal observations showed the reason most patients give for not participating in a clinical trial is quite simply that they aren’t asked or they didn’t know it was a possibility. As a breast cancer advocate, I tend to recoil at the notion of breast cancer awareness because I don’t think there are many adults (or kids, for that matter) who aren’t aware of breast cancer, but this is one area where I think a good old-fashioned awareness campaign would do some real good.
Moving Forward: Physicians Need Support
I wasn’t invited to be on the panel, but that doesn’t stop me from coming up with a few final thoughts and next steps! Clearly, the survey results and anecdotes the panel shared indicate that not enough adults in our country really understand the clinical trial process — what it is and why it is important. A full-on awareness campaign could really make a difference, and working with all the relevant stakeholders would be a phenomenal way to position this campaign for success. Having tried to help friends find clinical trials, I understand the extreme difficulty, and I count it a privilege to work with the team at Cure Forward to ease that burden on patients.
But sitting in that room, tucked under the Senate side of the Capitol, I realized that there is a huge burden on physicians who really do want the best for their patients, but lack the time required to do extensive, exhaustive searches on their patients’ behalf. I realized that Cure Forward can stand in that gap, not only providing a service to patients wanting to find a trial and sponsors looking for participants, but to time-strapped oncologists who want to ensure their patients find the very best trial. I sincerely hope that the CCTA can make considering a clinical trial as commonplace as the ubiquitous pink ribbon. And I am so happy to work with a team who will ensure that patients, now aware of the benefits, are spared the burdensome task of sifting through a haystack of inappropriate trial options to find the few needles that represent their best bets.
*Clinical Trials Awareness Capitol Hill Policy Roundtable 2017:
David Charles, MD – Chairman, Alliance for Patient Access & Medical Researcher
Ellie Dehoney – Vice President, Policy and Advocacy, Research!America
Jonca Bull, MD – Assistant Commissioner, FDA Office of Minority Health
Renata Louwers – Patient Advocate, Clinical Trials Writer
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Jamie Holloway is a both a scientist and a survivor, earning her PhD in tumor biology from Georgetown University a few years before her own breast cancer diagnosis. Now living with no evidence of disease after treatment for early stage triple negative breast cancer, she bridges the gap between scientists and researchers as a Precision Medicine Advocate for Cure Forward and as the Patient Advocate for the Metastatic Breast Cancer Project at the Broad Institute. She works with researchers as part of the Georgetown Breast Cancer Advocates and writes about her personal experience with cancer on her blog, Run Lipstick Chemo, and as a contributor to the Cure Magazine community.