Lance-DeGette Effort Improves Clinical Trials
WASHINGTON, D.C. --- U.S. Representatives Leonard Lance (NJ-07) and Diana DeGette (CO-01) teamed up on a bipartisan effort to improve clinical trials that was unanimously passed as part of the FDA Reauthorization Act. The Lance-DeGette effort would improve the way clinical trials are conducted to better measure the patient experience and ultimately help create better medicines and devices for the patient market.
“Clinical trials are where we discover cures and therapies that will save lives. We need to measure both the physical and psychological impacts of disease so the most informed decisions can be made on trial effectiveness. When patients participate in clinical trials, they are putting confidence in their team of doctors for what could be their best hope against challenging diagnoses. We need to make sure clinical trials are as strong as they can be and I am pleased to have bipartisan support on this effort with the help of Congresswoman DeGette,” said Lance.
“I was proud to work with Congressman Lance, together with the chair and ranking member of our committee, to fold provisions into the FDA bill that will deepen our understanding of the psychosocial impact of disease,” DeGette said. “As more is learned about the social and emotional effects of disease, we can deliver better outcomes for patients by improving medication adherence, tailoring treatment regimens, and enhancing participation in clinical trials.”
Lance and DeGette are members of the Energy and Commerce Committee, which crafted the bipartisan FDA Reauthorization Act to renew the system by which new medicines and medical devices are approved for patient use. The FDA reviews data from clinical trials to determine the safety and efficacy of new drugs. Lance and DeGette worked together to include new instructions for improving the patient experience and collecting data on the physical and psychological effects of disease and increasing participation in clinical trials. Recent evidence has shown that distress screening and follow-up in clinical trials leads to improved patient outcomes, enhanced clinical trial efficiency and better understanding of the burdens of clinical trials beyond the physical ones. The U.S. House-passed measure now heads to the U.S. Senate for consideration.