Clinical trials are an essential part of advancing new cancer treatments and reducing suffering and death from the disease. However, a significant percentage of cancer clinical trials never get off the ground because not enough patients enroll. Christine Weason, North Carolina government relations director of The American Cancer Society Cancer Action Network (ACS CAN), explains:
PRA is a proud presenting sponsor of ACS CAN’s ninth annual Research Breakfast, which focuses on the barriers to cancer clinical trial enrollments and efforts to overcome them.
ACS CAN is eager to better understand the barriers to clinical trial enrollment. So, after intensive research into patient challenges, our policy experts put together a new report, Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer.
The report, which was released this past April at ACS CAN’s annual national health policy forum, identified four overarching categories of barriers: provider and institutional, patient, trial design, and disparities.
These different barriers all contribute to a concerning reality—approximately one in four patients (27 percent) has access to clinical trials where they are being treated; yet, if asked to enroll in an available trial, more than half of eligible patients typically agree to do so. Most patients who actively decline to participate said they were afraid of side effects, losing control of their treatment or that they would encounter logistical or cost issues with enrolling.
The numerous barriers that keep patients from enrolling in clinical trials have been well researched but are often addressed in isolation from other barriers. The landscape portion of the report attempts to bring all the relevant evidence together in one place, synthesizing the relationships of barriers to each other and scaling each barrier’s contribution to the problem. This report is meant to serve as a resource to inform discussions and actions aimed at addressing the barriers.
The recommendations in the report require both programmatic activities and policy changes to be realized and are directed at cancer therapeutic trials and cancer patients. Examples include:
- Ensuring that research sites selected for multi-site trials have diverse patient populations that reflect the broader population with cancer.
- Create and implement ways to streamline the process and reduce effort needed to open clinical trials.
- Providing clinical trial navigation services for patients from medically underserved groups to connect with publicly available support resources and culturally sensitive education materials.
- Seeking engagement and partnerships with community leaders and community-based organizations–especially those serving racial and ethnic minority groups as well as medically underserved communities–to effectively disseminate information about the importance of clinical research participation as a social justice issue.
The demographics of participants in registrational trials for cancer drugs do not match the demographics of the U.S. cancer population, due in large part to many of these trials occurring outside of the U.S. Participants in NCI trials skew significantly younger than the U.S. cancer population and both minorities and the poor are also underrepresented in such trials.
Unlike adults with cancer, most children with cancer participate in trials, and corresponding advances in cancer outcomes for childhood cancer have been shown to exceed those for adults.
Enrollment of pediatric patients younger than 15 years old in clinical trials is around 50 to 60 percent. About half of these patients participate in treatment trials, and the remainder in observational cohort studies. Importantly, the structural and clinical environment for treatment of childhood cancers differs from the treatment of adult cancers, with most treatment of children occurring at a small number of specialized academic centers with a high proportion of care providers also involved in research.
There are a number of meaningful measures the cancer research community has identified to improve trial enrollment and many of these are already being pursued. We hope to continue to build on this progress and work together to make sure that patients interested in clinical trials don’t have anything standing in the way of their taking part.
- Increasing funding for trial-support personnel
- Shielding patients from out-of-pocket ancillary costs of trial participation such as travel, parking, and housing.
- Having stakeholders collaborate to develop free or affordable technology, tools and processes targeted toward non-research sites/providers that make matching patients to trial opportunities and referral of patients interested in trial participation easier.
The cancer community must do more to expand the reach of available trials and to make sure trials are designed so that those who want to participate can participate. ACS CAN, along with 14 other organizations from all sectors of the cancer research community including patient advocacy groups, provider groups, cancer institutions, and the drug research and development industry, developed a set of consensus recommendations to improve patient enrollment including making the discussion of specific trial options a more regular part of the doctor-patient treatment decision, increasing funding for trial-support personnel to help patients understand, enroll and manage their trial, and helping patients with added costs that occasionally result from trial participation.
The issue of barriers to patient enrollment in clinical trials is a new public policy arena that ACS CAN is addressing. This year, ACS CAN is conducting five clinical trial forums across the country, including one here in North Carolina, to focus on its Report: Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer.
We will convene key thought leaders and subject matter experts from the cancer community in each of the states to consider ACS CAN’s Barriers Report and to gain foundational insight to the barriers identified in the report and explore potential opportunities and promising practices that may alleviate the barriers patients confront in enrolling and participating in clinical trials.
We will consider the dialogue and discussion of the program policy experts, including the Directors from North Carolina’s three NCI designated comprehensive cancer centers, industry leaders from PRA Health Sciences, NC State Representative Greg Murphy, MD, and an UNC Researcher, along with his patient, who has participated in clinical trials. We hope to capture the experts’ salient points and apply this instruction and guidance to assist our organization to drive forward our development of public policy solutions and interventions for increased patient access to therapeutic clinical trials for cancer.
If we are to succeed in our mission to end suffering and death from cancer, it won't just happen in the doctor's office or research lab. This movement must start at the statehouse and in Congress. And, it will be led by volunteers - regular people whose lives have been impacted by cancer - rallying together to demand change from their elected officials.
ACS CAN is the organization empowering volunteers to do just that - influence change and impact the future of cancer. From gaining dramatic increases in funding for cancer research to ensuring all Americans have access to cancer care, our work is saving lives and leading to new innovative breakthroughs in how to fight this disease.
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