Clinical Trials:

Little is Known about Participation by Supplemental Security Income Recipients

GAO-14-734R: Published: Sep 9, 2014. Publicly Released: Sep 9, 2014.

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Daniel Bertoni
202) 512-7215
bertonid@gao.gov

 

Linda T. Kohn
(202) 512-7114
KohnL@gao.gov

 

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What GAO Found

Some Supplemental Security Income (SSI) recipientshave participated in clinical trials for rare diseases and received compensation for their participation in recent years. SSI provides cash benefits to low-income aged, blind, and disabled persons who meet the program’s eligibility requirements, and since April 2011, the Social Security Administration (SSA) has excluded this type of compensation for 36 SSI beneficiaries when determining their eligibility and benefit amounts as a result of its implementation of a statutory exclusion. The amountof compensation that SSA excluded for each recipient generally ranged from $50 to $2,000 each year. Annually, over 8 million individuals receive SSI benefits. Before 2011, federal law did not require SSA to exclude rare disease trial compensation for purposes of SSI eligibility and benefit determinations, and SSA did not require staff to specify this type of compensation in its records. As a result, SSA’s records do not indicate how many SSI recipients received such compensation before 2011. Further, neither the federal registry of clinical trials nor the rare disease organizations GAO contacted had data on SSI recipients’ participation in clinical trials—either before or after the exclusion was implemented.

Little is known about factors that affect SSI recipients’ decisions to participate in rare disease clinical trials, as they have not been specifically studied. However, time, travel requirements, and other factors have been found to affect participation in clinical trials in general, including those for rare diseases. In particular, the amount of time involved in trial participation, including time away from school and work, as well as travel requirements, are factors that affect individuals’ decisions to participate in trials, according to both literature GAO reviewed and rare disease organization officials GAO interviewed. For example, according to officials from one rare disease organization, a recent clinical trial required participants to be available on site at the trial location one day, every other week, for 8 months. According to studies we reviewed, additional factors that affect individuals’ decisions to participate include child care needs and a lack of awareness of the availability of relevant trials or the benefits of participating. Further, some factors that may positively influence individuals’ decisions to participate include a desire to help future patients, the potential for improved health status, and compensation. For example, financial incentives to participate in clinical trials have generally been found to encourage participation in trials, though some officials from clinical care centers noted that compensation decreased participation in clinical trials in the past for individuals who were concerned about its impact on their SSI eligibility and benefits.

Why GAO Did This Study

Clinical trials can help to generate the evidence base for decision-making about the use of new treatments or drugs, and can be especially important for patients with serious or life-threatening health conditions who have limited treatment options. However, because trials are dependent upon voluntary participation from individuals who meet trial-specific criteria, successfully conducting a clinical trial can be challenging if there is a small pool of potential participants, such as individuals with rare diseases. Further, individuals may choose to participate or not participate for a variety of reasons. For example, SSI recipients may be discouraged from participating if the clinical trial offers compensation that could affect their SSI eligibility and benefits, as these are, in part, based on an individual’s income and resources. The Improving Access to Clinical Trials Act of 2009 required that SSA exclude up to $2,000 annually in compensation received by individuals who participate in rare disease clinical trials when determining SSI eligibility and benefits. The act also mandated that GAO review the impact of this change on SSI recipients’ participation in rare disease clinical trials.

GAO assessed what is known about SSI recipients’ participation in clinical trials for rare diseases, including compensation received for their participation, and the factors that affect SSI recipients’ decisions to participate. GAO reviewed SSA’s data on SSI recipients since the agency began excluding rare disease trial compensation in April 2011, national clinical trial data for calendar years 2008 through 2013, and literature on factors that affect individuals’ decisions to participate in clinical trials; interviewed relevant federal agencies and rare disease organizations; and reviewed relevant federal laws, regulations, and guidance.

What GAO Recommends

GAO is not making any recommendations. 

For more information, contact Daniel Bertoni at (202) 512-7215 or bertonid@gao.gov or Linda T. Kohn at (202) 512-7114 or kohnl@gao.gov.

 

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