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New Legislation Seeks to Boost Participation in Clinical Trials for Rare Diseases
Date:6/15/2009

Bill would remove financial penalties for participating in research studies

BETHESDA, Md., June 15 /PRNewswire-USNewswire/ -- New legislation introduced today would allow patients with rare diseases to participate in clinical drug studies without losing their eligibility for government healthcare coverage.

The "Improve Access to Clinical Trials Act" is co-sponsored by Representatives Edward J. Markey (D-MA) and Cliff Stearns (R-FL) and 30 members of the House of Representatives.

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.

Researchers developing drugs to treat rare diseases struggle to recruit participants for clinical trials because of limited patient populations. This is particularly true for cystic fibrosis (CF). More than 30 promising CF drugs are in development, yet only about 30,000 people in the U.S. have this life-threatening, genetic disease.

"We are grateful to Representatives Edward Markey and Cliff Stearns for introducing this important bill that allows more people with rare diseases - including cystic fibrosis - to participate in clinical trials," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "Cystic fibrosis is a devastating disease and this new legislation clears the way for promising drugs to move more swiftly from the research phase into the hands of people who need them."

Fifty years ago, there were no drugs for people with CF and those with the disease rarely lived to attend elementary school. Today, because of the Cystic Fibrosis Foundation's focus on innovative and aggressive research, there are more than 30 potential therapie
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SOURCE Cystic Fibrosis Foundation
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