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Advocacy >   The case for reimbursing study participants

for the extra costs they incur from study participation while avoiding undue influence

The goal of this proposal is to remove financial barriers to participation in studies,
NOT to influence the decision.


Last update: 12/01/2015

"greater participation of lower-income patients would allow trials to be conducted more quickly, speeding the development of new treatments."  

Joseph M. Unger,  Hershman, MD, et al 1
 

For patient's participating in a clinical trial, the extra costs in terms of both time and money may make it difficult for low and middle income patients to participate. A recent report from JAMA shows that lower income patients are not equally represented in clinical trials.

We are proposing that some reimbursement to patients for documented expenses like travel and time off work may increase participation and help reduce income related sample bias.    

If we can get this right without subjecting lower income persons to undo influence we might: 1) increase participation in clinical trials; 2) reduce income disparity in study samples thereby improving generalizability of results. 3) Improve access to investigational therapies and; 4) improve trial accrual rates.

Background:  Clinical trials can require much more of the patient than what is asked of them when receiving regular care.2  This may include numerous research-related blood tests, extra monitoring scans, and /or additional biopsies.

The physical, social, and financial burden of cancer itself and the extra demands of trial participation can be overwhelming - the latter is especially true for persons who can barely make ends meet.  This is supported by a recent JAMA report on a prospective study on the barriers to trial participation, which concluded:

* lower-income patients were less likely to participate in clinical trials.  Lower-income patients are likely more sensitive to marginal financial expenditures than higher-income patients.

* Incentives or reimbursements may be appropriate, though they should not be coercive to patients.

*  One approach to alleviate the financial risk associated with clinical trial participation would be to cover the excess costs of participation, including copayments and coinsurance.  Direct compensation to clinical trial participants has also been recommended.6

* Considerations with respect to time off from work, child care, and transportation could also improve access to clinical trials for lower-income patients. Future research should investigate how to overcome financial barriers to clinical trial participation.

* The identification of patient income level as an independent predictor of trial participation is important for multiple reasons.  If income is associated with health status, then improving representativeness of lower-income patients in trials would improve the generalizability of study outcomes.

* Also, greater participation of lower-income patients would allow trials to be conducted more quickly, speeding the development of new treatments. Crucially, since clinical trial treatments represent the newest available treatments, access to this vital resource should be available to individuals of all income levels."


Source: Patient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study 1:

Here we propose that reimbursement for expenses be provided to study participants. The goal is to remove financial barriers to participation in studies without it being an incentive to take part.  Specifically, we propose that the sponsors reimburse for the following expenses needed to take part in extra research-related tests and procedures:
bullet
For travel
bullet
For the cost of preparing the study drug

When the participant's insurance does not pay for this.
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For Meals (on a per diem basis)
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For the patient's time off from work if employed
(on a per diem rate, perhaps based on what is due to citizens who serve on jury duty.

Requiring documentation that the participant has taken time off work.
bullet
For the cost of care for the participant's under-age or elderly dependents*

Requiring documentation that the participant has such dependents

Note: It is standard practice for the sponsor to pay for research-related tests and procedures, AND for regular tests that are given more frequently for research purposes. Typically, these extra tests are done to gain knowledge and not for the direct benefit of the study participant. 

It's time to recognize the service to society provided by the participants of clinical research ... not by words, but by our policies and actions Current practice is well-intended to avoid coercion and undue influence, but failing to reimburse the participants for their expenses could well exclude lower-income persons from taking part in clinical research, which can be the only prudent choice for an individual when regular treatments are proven to be ineffective.  This omission also delays progress that is needed to test and find better treatments for life-threatening diseases, and limits the generalizability of study findings.* 

*
In Medicaid (low-income) populations access to transportation and child care are known to be established causes of missed appointments and, thus, poorer outcomes.4

We canít let the perfect be the enemy of the improved. That patients may well be priced out of participation, or must pay extra out of pocket to participate (for the benefit of us all) is clearly wrong ... and is costing us all. The devilish details have to be worked out to everyoneís near satisfaction. Common sense and now evidence from a prospective study is saying the same thing: there's a pressing need to stop imposing financial penalties on study participants - for their sake and ours! 

   

What about costs?

That reimbursing patients for their expenses might increase the expense of doing clinical research ought not be the issue -- after all every stakeholder in research receives compensation and what they realize vastly exceeds their expenses or they would not do it.   But the question has been raised so let's examine it.  Per patient cost of running trials is rising and has been estimated to be about "$40,000 per patient" for late-phase trials.3  The most significant factor for the increase cited in the 2011 report was "patient recruitment."  For discussion sake, if the average reimbursement to the patient is about $1,000,that would increase the cost per patient by 2.5% -- which could be completely offset by more efficient patient recruitment!  (More patients would be able to participate.)

What about undue influence?

If we get it right (what is reimbursed matches well with the patients expenses for research-related tests and procedures), it's a difficult to understand how this amounts to undo influence.  The patient has a life-threatening illness and will also be guided in many cases by his or her independent treating physician.   Are we to believe that the patient would choose a study over regular care simply because she will get reimbursed (and modestly) for the expenses she would not otherwise have?  

What about the administrative burden?

The policies and procedures can be standardized in order to minimize the administrative burden to the centers and to facilitate IRB approvals.  Standard forms, instructions, and per diem reimbursements can be used for meals, travel, lodging, and time. 


What is the impact of current practice on enrollment overall?

Mike's story (below) suggests that failing to reimburse the participant for his or her expenses (substantial in his case) might reduce participation rates overall - across other income groups.

 

Click to comment or ask a question

Related resources:

  1. JAMA Oncology, 2015:
    Patient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study http://bit.ly/1LUuaJq 
  2. The ASCO Post, April 2015 by By Lee M. Krug, MD
    On trial participation: ďDoctor, is this all worth it?Ē The tests, procedures, can be burdensome http://bit.ly/1kkoMt9

    "Consider the following scenario:

    MD: Hello, Ms. Smith. Thanks for coming in today. As we discussed at our last visit, the computed tomography (CT) scan showed that the chemotherapy has stopped working, and we need to come up with a plan for your next course of therapy. There are other chemotherapy options, or we could consider a clinical trial with a new drug.

    Ms. Smith: I canít say Iím too enthusiastic about getting more chemotherapy. Tell me more about the clinical trial.

    MD: We have seen excellent results with this drug in other cancers, and we think it has a good chance of working in your cancer also. You are in good shape, so I think you would make an excellent candidate for the study.

    Ms. Smith: That sounds encouraging. Can I start that treatment today?

    MD: No. First you need to have some testing done to make sure you are eligible to participate. You will need to come back later this week to get some blood work and three electrocardiograms (ECGs).

    Ms. Smith: Can I get the blood work done today while I am here?

    MD: No. It needs to be collected in the morning after fasting.

    Ms. Smith: Ugh, okay. Itís just that I live an hour away. Can I start after that?

    MD: Well, you also need a biopsy of the tumor in your lung.

    Ms. Smith: Donít we already know this is cancer?

    MD: Yes, but this biopsy is being done for research purposes.

    Ms. Smith: When will I get the results of this biopsy?

    MD: You wonít. The samples are sent to the pharmaceutical company for analysis.
     

  3. 2011 report -- probably higher still:
    Per-Patient Clinical Trial Costs Rise 70% in Three Years

    "But the largest increases in per-patient costs came in Phase IIIa and Phase IIIb, which saw an average 88 percent and 86 percent rise, respectively. The study found that both Phase IIIa and Phase IIIb per-patient costs now top $40,000 compared to approximately $25,000 three years ago. Phase IV (post-marketing studies) costs also rose, but at a more modest 31 percent, on average.

    "The most significant factor for increased clinical trial costs is patient recruitment," said Adam Bianchi, chief operating officer of Cutting Edge Information. "This comes as no surprise because clinical development teams have struggled to enroll sufficient volunteers to fill trials for several years now. But other factors, such as site recruitment challenges and vendor management, also play a big part in the rising costs we now see."
  4. Health Disparities Based on Socioeconomic Inequities: Implications for Urban Health Care: Academic Medicine http://bit.ly/1MGmyeh

Mike's Story

As a trial participant , I note that although some of the extra costs associated with the trial were borne by the trial (primarily the cost of the study drugs and associated health care costs), most were not.

My maintenance treatment extended several years longer than that usually scheduled, and as a result, I paid several thousand dollars out of pocket to pay for the added treatment. I'm hopeful that this will be a beneficial result of the trial, but it would be incorrect to say that this hasn't placed a financial burden on our family.

Fortunately, the company has instituted a co-pay card which helped cover the cost of extended treatment, but did not cover all the extra costs.

I personally would not ask for total reimbursement of costs in my financial position (wage earner with decent, but by no means extravagant health insurance), but I could see where those that have a need for extra transportation over longer distances, etc. could find a barrier to trial participation when these expenses are not covered.
 

Typical language in a consent form on the costs of taking part in a clinical trials

What are the costs of taking part in this study?

Both XYZ and ABC will be supplied at no charge while you take part in this study. It is possible that XYZ and ABC may not continue to be supplied while you are on the study. Although not likely, if this occurs, your study doctor will talk to you about your options.

You will not be charged for any costs related to the blood samples that are collected for research purposes. These samples are not used for testing that affects your care.

You and/or your health plan/insurance company will be billed for all standard costs of treating your cancer, including the cost of tests, procedures, or medicines to manage any side effects. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for.

You will not be paid for taking part in this study.

[In this example there is no offer to reimburse for travel or taking time off work  in order to have study-related tests or procedures.]

 
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