Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today's challenges and opportunities. The Catalyst welcomes guest contributors including patients, stakeholders, innovators and others to share their perspectives and point of view. Over the coming weeks and months, Clinical Trials Q&A, will highlight different aspects of the clinical trials process from the people and organizations on the front lines of bringing essential medicines to the patients that need them. Like our Conversations series, views represented here may not be those of PhRMA, though they are no less key to a healthy dialogue on issues in health care today.
This is the second post in our Clinical Trials Q&A series with individuals and organizations on the front lines of bringing essential medicines to the patients that need them. We know that, in many cases, participation in clinical trials can offer the best chance for access to a new, promising therapy for patients. Yet, fewer than 5 percent of adult cancer patients enroll in a clinical trial. To learn more about what the National Patient Advocate Foundation (NPAF) and Patient Advocate Foundation (PAF) are doing to address the problem, we talked with Lisa Hughes, Director, Strategic Partnerships and Projects, National Patient Advocate Foundation.
JOCELYN ULRICH: Why is it hard to recruit volunteers for oncology trials?
LISA HUGHES: The question of why accrual in clinical trials remains low and how to address this has plagued the oncology community for decades. We’ve identified multiple barriers that discourage participation, originating from different components of the clinical trials system, ranging from the regulatory burden of conducting trials, physician/patient communication, insurance coverage, and patient education. These burdens are discussed at length in Securing the Future of Cancer Innovation and Responsibility for Costs Associated with Clinical Trials.
JOCELYN ULRICH: What is NPAF doing to help increase education and improve patient recruitment?
LISA HUGHES: Our organization, alongside others in the community, continues to educate and advocate for policy change to address these issues. We have initiated a coalition called Project Innovation, through which we provide resources to the public and policymakers as to why clinical trials are an essential component of research innovation but also in many cases they may be the best treatment option for a patient. The site also serves as a clearinghouse of resources for patients and caregivers, and features information and infographics explaining the clinical trials process, myths and facts, and terms often heard when talking about clinical trials.
Our website features a merkel cell carcinoma patient enrolled in a clinical trial, who shares, in his own very powerful words, why he made the decision to participate in a trial. In his video, Stan Collender states that “at least for merkel cell, the systemic treatment didn’t exist, except on an experimental basis…so the clinical trial became a real, favorable option and I didn’t want to wait for something to happen. I wanted to get ahead of it,” explains Stan. “This is exciting, because I’m not only helping myself. Getting healthy is the primary motivation, but based on what they find from me, I’m also going to be able to help other people.”
JOCELYN ULRICH: In addition to educating patients, what else can be done to improve awareness?
LISA HUGHES: While patient education is critical, another regularly identified barrier to enrollment is the often insufficient dialogue between provider and patient. Patients and caregivers, while wanting to educate themselves about all available treatment options, also rely on their health care team to include a discussion about clinical trials that they may be eligible for. Our Project Innovation website also features the perspectives of health care professionals Dr. Shailender Bhatia and Research Coordinator Cassie Oh, sharing why from the provider point of view, clinical trials may be the best choice of treatment for many of their patients.
Ultimately, improving patient awareness of and enrollment in clinical trials will take continued collaborative efforts among stakeholders, particularly as trials become more targeted and personalized with the growth of precision medicine as a method of care. Our organization and community are committed to both education and policy change to ensure that clinical trials continue to benefit patients and serve as a driver of innovation.
Lisa Hughes is the Director, Strategic Partnerships and Projects, National Patient Advocate Foundation and leads the Project Innovation and Cancer Innovation Coalition initiatives of the Patient Advocate Foundation and National Patient Advocate Foundation.
Jocelyn Ulrich Jocelyn Ulrich, MPH, is Deputy Vice President, Policy and Research, at the Pharmaceutical Research and Manufacturers of America (PhRMA). At PhRMA, she is responsible for developing legislative and policy analysis and research studies on a range of issues impacting innovative biopharmaceutical companies including intellectual property issues, FDA policy issues, the R&D process, the value of innovation, and other issue areas impacting the environment for innovation. In addition to her experience at PhRMA she has over 15 years of experience in the pharmaceutical industry at Pfizer, Human Genome Sciences, and EMD Serono in roles in clinical research management, investigator-initiated and collaborative research, and global policy and corporate affairs. Jocelyn holds an MPH in global health policy and management from New York University.