There are 30 million Americans living with what S. 139 calls “rare diseases or conditions.” It is difficult enough facing such disorders, but it can be even more difficult finding those willing to participate in clinical trials to provide information, treat and perhaps even cure these conditions. The definition of “rare disease” in the U.S. is “any disease or condition where the prevalence is less than 200,000 patients.” In an interview in pharmaphorum Yaffa Rubenstein, of the Office of Rare Diseases USA-map-ColourResearch (ORDR), explained there are “…more than 6,800 rare diseases known today.”
On September 28, 2015, Congress maintained federal support for the participation of low-income Americans in clinical trials for these conditions. The bill, titled “Ensuring Access to Clinical Trials,” includes renewal of the Improving Access to Clinical Trials Act of 2009, which allows compensation for participation in clinical trials to those on Supplemental Security (SSI) and Medicaid. The Improving Access bill directs that “the first $2,000 per year received by individuals who participate in clinical trials for rare diseases or conditions” are not counted against the individual’s eligibility for SSI and Medicaid benefits.
The bill has passed both the House and Senate and was signed by the President (became law) on the 7th October 2015.

Trial participants

Finding clinical trial participants is a growing challenge. According to the Tufts Center for the Study of Drug Development, clinical trial enrollment rates overall have dropped 20 percent since 2000, with only 2 million volunteers now participating, thereby creating elongated timelines in 85 percent of trials.
Lack of financial reimbursement is often a major turn-down factor, especially among the low-income population. In a research report, Joseph M. Unger, PhD, a health services researcher and statistician with the Fred Hutchinson Cancer Research Center in Seattle, wrote that “patients whose income was less than $20,000 a year were 44% less likely to participate in a clinical trial” than higher-income patients.
For example, less than 5% of adult cancer patients participate in cancer trials, according to one study with the National Cancer Institute’s (NCI) State Cancer Legislative Database. These include few participants among those with low income, those in rural areas, those without some form of health insurance, those age 65-plus and others often overlooked.
The NCI study concluded: “Increasing the participation of underrepresented groups in clinical trials is a national research objective.”

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