Half of all clinical trial delays are a result of patient recruitment problems. Imagine the struggle faced by researchers of rare diseases. In addition to the normal recruitment problems, as well as the standard 20-30% post enrollment dropout rate, they are working with very limited patient populations.
To get viable results for rare disease studies you need adequate participation. The problem is people receiving Supplemental Social Security income are not allowed by US law to accept compensation for research. Doing so makes them ineligible to receive government medical benefits and prevents them from participating in clinical studies. Take that limited pool of participants and make it smaller. Now find a cure. Good luck.
As of the end of September, over 100 patient, academic and industry organizations have joined to support legislation that enables individuals with rare diseases to participate in clinical trials without losing their eligibility for government assisted healthcare benefits. Some of these include the Cystic Fibrosis Foundation, Johns Hopkins Hospital, the National Health Council, PhRMA and the Yale University Medical College.
According to Robert Beall, PhD., President and CEO of the Cystic Fibrosis Foundation, “Clinical trials are critical for developing effective therapies for cystic fibrosis and dozens of other rare diseases. Quick passage of this bill by Congress will support life-saving research for many people in need.” (Medical News Today 9/29/09)
The bill was introduced into the Senate September 16th and is called “The Improving Access to Clinical Trials Act.”
“This bill allows patients with a rare disease to disregard up to $2,000 of compensation received for participation in a clinical trial in their SSI and Medicaid income calculations,” said Senator Inhofe. “Though it will have a negligible impact on the federal budget, it will make a dramatic difference in the lives of those who will gain access to potentially life-saving treatments by enrolling in clinical trials as well as all those in the future whose lives will be improved by the medical advances that arise from this research.”
Over 30 million Americans are afflicted with one of the roughly 700 existing rare diseases and it is estimated two new pathologies are described every week in medical publications.
To track the current status of this bill, please click here: http://www.govtrack.us/congress/bill.xpd?bill=h111-2866
Please feel free to let your elected House and Senate representatives know you support this bill. Their contact information can be found here: http://www.usa.gov/Contact/Elected.shtml
You can even Tweet your support!
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