May 2011

New Law Opens Doors for CF Clinical Trial Volunteers

Advocates Speak Out on Capitol Hill
Amy and Peter Barry, National Advocacy Co-Chairs, joined advocates from across the country to speak out on Capitol Hill for the “Improving Access to Clinical Trials Act” and other issues important to CF.

This spring, because of the efforts of Cystic Fibrosis Foundation volunteers across the nation, a new law will allow more people with cystic fibrosis to participate in clinical research studies.

The legislation, called the “Improving Access to Clinical Trials Act,” protects people with CF and other rare diseases from losing their public health coverage because of income earned from clinical trials.

An estimated one half of all people with CF rely on some form of public health coverage, according to a recent study by the Foundation.

Many patients who rely on programs, such as Supplemental Security Income (SSI) or Medicaid, have been unable to participate because of requirements that any compensation earned from clinical trials be counted as income.

The Foundation was the first organization to identify this barrier to clinical research and collaborated with CF Caucus Co-Chairs Reps. Edward Markey (D-Mass.) and Cliff Stearns (R-Fla.), and Sens. Ron Wyden (D-Ore.), Richard Shelby (R-Ala.), James Inhofe (R-Okla.) and Christopher Dodd (D-Conn.) to write the bill and lead the charge toward passage.

The law is especially important for cystic fibrosis because a limited patient population makes it challenging to find enough people to participate in research studies needed to test the effectiveness of promising new drugs.

“We are thankful to the CF advocates and our champions in Congress who made this momentous achievement possible,” says Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. “This important legislation will benefit 25 million Americans with rare diseases and will help swiftly move promising new treatments from the research stage to the patients who need them most.”

People with CF who participate in clinical trials receive, on average, $750 per study. This money compensates patients for their time and covers any expenses they incur as a result of participating in the trial, such as transportation or meals.

Under the new law, which will take effect in April, patients can earn up to $2,000 dollars each year from clinical trials without having that compensation counted toward their income.

“This is a big victory for the CF community,” said National Advocacy Co-Chair Amy Barry. “Patients should not have to choose between participating in important clinical research and keeping their health coverage. And now, they won’t have to!”

People with cystic fibrosis who participate in clinical trials also find volunteering has its own rewards. Volunteers may get access to investigational drugs before they become available to the public, they can take a more active role in their own health care, and they can feel good knowing they are helping to find new therapies to improve the quality of life for everyone with CF.

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