Clinical Trial Protections Sought

April 24, 2002

Tue Apr 23, 4:37 PM ET

WASHINGTON (AP) - Senators are promising legislation to better protect

patients who volunteer for clinical trials amid growing concerns about

the way many of the experimental tests are being administered.

" The protections of the past are proving inadequate to keep up with the

pace and volume of new discoveries, " Sen. Kennedy (news, bio,

voting record), D-Mass., chairman of the Senate Health, Education, Labor

and Pensions Committee, said at a Tuesday hearing. " We must revitalize

our system of protections for this new century of the life sciences. "

Kennedy, who plans to unveil his legislation soon, has said he supports

accrediting the institutional review boards, who ensure that trials meet

federal standards. Kennedy has also hinted that he wants to strengthen

provisions that require that patients be informed of any safety issues.

Sen. Bill Frist (news, bio, voting record), R-Tenn., said lawmakers must

remember to " consider the past without becoming consumed by it. "

" Rather than mistakenly stopping critical research, we should create a

research environment that both protects human participants and encourages

research, " Frist, a surgeon, said.

Last year, the government temporarily shut down nearly all federally

funded research on human subjects at s Hopkins University after a lab

worker died while taking part in an asthma study.

Cherlynn Mathias, a registered nurse who had been a study coordinator at

the University of Oklahoma, told the committee of a 1999 clinical trial

where there was a lack of safety testing for the drug being administered.

The trial also failed to fully report adverse side effects patients

experienced, Mathias said.

" Unfortunately, this sad situation of not reporting adverse events is the

same across the nation, " she said.

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