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Senate Introduces Bill to Boost Participation in Clinical Trials for Rare Diseases
Date:9/16/2009

Bill would remove financial penalties for participating in research studies

BETHESDA, Md., Sept. 16 /PRNewswire-USNewswire/ -- Four members of the United States Senate introduced legislation today to allow patients with rare diseases to participate in clinical drug studies without losing their eligibility for public healthcare coverage, echoing a move by the House of Representatives last month.

The "Improving Access to Clinical Trials Act" is co-sponsored by Senators Ron Wyden (D-OR), Chris Dodd (D-CT), James Inhofe (R-OK) and Richard Shelby (R-AL).

Researchers who develop drugs to treat rare diseases such as cystic fibrosis often struggle to recruit participants for clinical trials because of limited patient populations. To compound the problem, current law prevents many people who receive Supplemental Security Income (SSI) from accepting research compensation because it would make them ineligible to continue receiving government medical benefits. This financial penalty prevents significant numbers of people with rare diseases from participating in clinical studies.

"For many suffering from rare diseases, access to clinical trials is their best hope for treatment," said Senator Wyden. "This legislation will make sure the small financial incentives these people receive will not be counted against them if they are on SSI or Medicaid. Patients suffering from rare diseases should not have to choose between their best hope for treatment or losing benefits, nor be denied the access more financially fortunate patients receive."

"For those living with a rare disease, clinical drug studies can offer a ray of hope: access to cutting-edge medical technologies that may help treat or even cure a serious illness," Senator Dodd said. "Currently, individuals who receive public assistance often do not participate in compensated clinical trials
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SOURCE Cystic Fibrosis Foundation
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