CONGRESSIONAL RECORD
SENATE
Oct. 7, 2004
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
Mr. WYDEN. Mr. President, today I join Senators DODD, KENNEDY, and JOHNSON in introducing the Fair Access to Clinical Trials Act of 2004. This legislation is an important milestone for patients and doctors around this country because it would create a centralized clinical trials registry by expanding the current clinical trials.gov website to provide not only information about clinical trials they might want to be part of, but also the results of those trials. If information is not provided so it can be posted on the website, serious penalties could be imposed, including a researcher losing their ability to get future Federal grants.
It is vitally important that patients and their doctors have the information they need to decide upon the best treatment for them. As we all know, drugs are often the key treatment for many health problems. Good results about the safety and effectiveness of treatments are often trumpeted by drug companies and the media, but Americans are less likely to hear about clinical trial results that are not so good or truly negative. This legislation will ensure that everyone can get a fair picture of all results of clinical trials.
I believe that this legislation strikes the delicate balance needed so that companies which create breakthrough drugs can keep their trade secrets, the important process of assuring peer review in medical literature can continue, and consumers, doctors and researchers can have access to the information they need to make sound decisions about their health care.
Research is key in assuring health care improvements. Knowing the results of research is key in assuring better health care quality and improving decision-making by doctors and their patients. I believe that the expanded website created by this legislation will be an important tool in improving doctors' and patients' knowledge and decision-making that might well mean life or death for some patients.