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Thursday, December 20, 2018

3 Questions on...ASCO's Statement on the Financial Barriers to Clinical Trial Participation

With Beverly Moy, MD, Clinical Director of the Breast Oncology Program at Massachusetts General Hospital

By Sarah DiGiulio

When a patient participates in a clinical trial, costs of medications and/or interventions are covered by the funding for the trial as a way to ensure that clinical trials get fair and equal participation. But there are other costs associated with participating in a clinical trial that go beyond whatever intervention is being administered or tested in the trial. There are supportive care costs that aren't covered by the clinical trial, and there may be travel and/or lodging costs to make it possible to participate in a clinical trial.

It's a topic that has gotten the attention of medical ethicists, including two at the University of Pennsylvania, who penned a viewpoint article in JAMA Oncology earlier this year calling for the FDA to allow for incentives to encourage participation in clinical trials, such as reimbursement for participation expenses, as well as compensation for patients' time and effort (Oncology Times 2018;40(19):66). They say such incentives are not coercive, but instead facilitate fairer participation.

ASCO also recently took a stand on the issue, releasing a policy statement with recommendations to lessen financial barriers to cancer clinical trial participation (J Clin Oncol 2018;36(33):3331-3339).

"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," ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, said in a press release accompanying the statement. "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."

The recommendations (which include more specific directives) include the following:

  1. Clinical trial cost payment policies should be revised to be made more consistent, streamlined, and transparent to all stakeholders.
  2. Patients should be provided clearer information about potential trial-related expenses during the development and enrollment process.
  3. Financial compensation for out-of-pocket costs should not be considered undue inducement and impediments to such reimbursement should be removed.
  4. Research to better understand patient costs of clinical trial participation should be incentivized, as well as investigations of tools to mitigate the risk of trial-associated financial hardship.

In an interview with Oncology Times, one of the ASCO statement co-authors, Beverly Moy, MD, Clinical Director of the Breast Oncology Program at Massachusetts General Hospital in Boston, explained why addressing this issue in cancer care is so important now.

1. What prompted ASCO to issue this statement now and what's most important to know about this topic?

"Among ASCO's most important priorities are to ensure access to quality cancer care and to promote research. Underserved patients, including racial and ethnic minorities and poor patients, face nearly insurmountable obstacles to clinical trial enrollment. Therefore, in line with ASCO's mission, the removal of financial barriers to clinical trial enrollment is a topic where ASCO advocates vigorously.

"The recommendations include the improvement of payer clinical trial policies; providing patients with clear, transparent information about potential trial-related out-of-pocket costs; removal of impediments to ethically appropriate financial compensation for out-of-pocket costs; and incentivized research to better characterize the financial burden of trial participation.

"Oncologists should be aware of the added financial burden of clinical trial participation—and demand policy changes to make it possible for our underserved patients to participate. This is an important social justice issue. Patients should not be deprived of these important cancer treatment options due to financial barriers."

2. There are a lot of groups and stakeholders that need to act to fix this problem. How will these recommendations accomplish that?

"Our specific recommendations provide some concrete solutions to some of the various reasons why there are financial barriers to clinical trial participation. Removing perceived impediments to reimbursing patients for their out-of-pocket costs will make it possible for patients to incur more financial burden by participating in a cancer clinical trial. Increasing the transparency from the payer and sponsor perspective as to who is responsible for specific costs will provide patients reassurance and clarity about the financial implications of clinical trial participation.

"This statement stems from a multi-stakeholder roundtable and summarizes their comments and input. These stakeholders included the FDA, NCI, industry, payers, patient advocates, the Moonshot initiative, private cancer foundations, and academia. With increased recognition of this problem, we are hoping to bring attention to this critically important matter so that stakeholders will make meaningful changes to remove financial barriers to clinical trial participation."

3. Two ethicists recently published an editorial in JAMA Oncologyarguing that the policy banning financial compensation for clinical trial participation for ethical reasons plays a big part in financial barriers limiting clinical trial participation. Does the ASCO statement address their concerns?

"[These ethicists] thoughtfully discussed the important ethical issues behind this critically important issue. I'm glad that they supported many of the points that we made in the statement. Our third recommendation explicitly discusses the removal of impediments of ethically appropriate financial compensation for costs and brings up many of the same points made by the authors of the JAMA Oncology paper."