This article is more than 5 years old. Information may no longer be current.
ASCO policy statement targets financial barriers to clinical trial participation
Click Here to Manage Email Alerts
A policy statement issued by ASCO emphasizes the importance of increasing participation in cancer clinical research trials and outlines recommendations to improve access for underserved populations.
“Clinical trials are essential for evaluating the safety and efficacy of new cancer treatments, but cancer researchers have seen consistently low patient participation levels — especially among underserved patient populations — in part due to the financial burdens facing many patients with cancer,” Monica M. Bertagnolli, MD, FACS, FASCO, president of ASCO, said in a press release. “Addressing financial barriers will help improve the enrollment rate and the efficiency, quality and applicability of cancer research. By including more — and more diverse — participants in our research studies, we expand our ability to care for all patients.”
HemOnc Today spoke with Karen M. Winkfield, MD, PhD — associate director for cancer health equity at Wake Forest Baptist Comprehensive Cancer Center and former chair of ASCO’s Health Equity Committee — about why ASCO identified this as an important area of need, how the policy statement was created, and the rationale behind each recommendation.
Question: When did ASCO identify this as an important area of need?
Answer: We had questions about financial toxicities associated with cancer clinical trials, but did not formally begin exploring the idea until February 2017. This is when we held our first phone call to convene a steering group comprised of key experts tasked with outlining what we hoped to achieve by bringing together stakeholders for a roundtable discussion.
Q: How did ASCO create its policy statement?
A: This policy statement — “Addressing Financial Barriers to Patient Participation in Clinical Trials” — is a product of a long and thoughtful process that began with discussions among the policy staff at ASCO, Beverly Moy, MD, clinical director of the breast oncology program at Massachusetts General Hospital, and myself. The statement stemmed from research that Dr. Moy and I collaborated on in conjunction with the Lazarex Cancer Foundation that focused on reducing financial barriers to clinical trials. Once the steering committee was formed, we collectively identified key stakeholders to bring to the table, including survivors, experts, ethicists, individuals from the pharmaceutical industry, and individuals from the government sector. An environmental scan was performed to identify manuscripts and data to help provide a comprehensive overview of the topic, policy regulating trial participation, and best practices for reducing financial barriers.
Q: Why is the recommendation on improving payer clinical trial coverage policies important?
A: Certain insurers that were grandfathered into the Affordable Care Act may be able to deny coverage for some of the routine costs associated with clinical trials. There is an assumption that clinical trials will cost a lot of money to insurance providers but, if a new device or drug is being investigated as part of a therapeutic trial, it often is provided at no cost. Additionally, most studies are created such that if any labs or imaging is required beyond what is considered standard of care, those costs are covered by the institution or the clinical trial itself. On the other hand, costs may increase if more frequent monitoring of patients — more clinic visits — is required. It is very challenging to have certain insurers who will not cover care if a patient is on a clinical trial.
Q: Why is the recommendation for transparency regarding out-of-pocket costs important?
A: There is not good data out there on what should be covered in a clinical trial. We need to gather this data in an effort to generate guidelines. To help patients and researchers plan for care, it would be beneficial for insurers to be transparent if there are clinical care items that will not be covered for patients enrolled on clinical trial.
Q: Why is the recommendation on removing impediments to ethically appropriate financial compensation for such costs important?
A: Refuting the specter of inducement is necessary. Most oncology care occurs in the community setting, with 80% of patients treated closer to home. Community settings may or may not have access to clinical trials, so if a patient has pancreatic cancer, but a study is located thousands of miles away from them and they want to participate, they may not have the financial ability to do so. The Lazarex Cancer Foundation has stepped in to cover some of the travel costs for these patients. However, we need to look for sustainable solutions, and that may include allowing sponsors of clinical trials to provide financial support to participants to help cover some of incremental ancillary costs that may be associated with their participation in a clinical trial.
Q: Can you explain the importance of the recommendation to incentivize research that will better characterize trial-related patient costs and support the development of tools to identify and mitigate the risk for trial-associated financial hardship?
A: We have some data on the cost of running a clinical trial from an institutional perspective, but very little data have been compiled exploring the cost of clinical trial enrollment from a patient perspective. We need to find better ways to quantify the financial toxicity of cancer care in general and then to understand the incremental cost associated with clinical trials.
Q: What is the potential impact of these recommendations?
A: If some of these policy recommendations are adopted, it will afford more people the opportunity to participate in clinical trials. An estimated 3% to 6% of patients with cancer enroll in cancer clinical trials. This significantly reduces our capacity to move the field forward quicker. Clinical trials generate new information and allow new drugs to be brought to the market. If we can provide clinical-trials support to more people, it will ensure that folks who are traditionally underrepresented in trials may have the capacity to enroll.
Q: Is there anything else that you would like to mention?
A: This statement is a first step. It would be wonderful for this policy statement to be the matchstick that ignites further discussion on how we want cancer care to be in this country. Transparency around these issues will help us figure out what to do to help those who are suffering. – by Jennifer Southall
Reference:
Winkfield KM, et al. J Clin Oncol. 2018;doi:10.1200/JCO.18. 01132.
For more information:
Karen M. Winkfield, MD, PhD, can be reached at Wake Forest Baptist Health, 1 Medical Center Blvd., Winston-Salem, NC 27157; email: kwinke@wakehealth.edu.
Disclosure: Winkfield reports no relevant financial disclosures.