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Senators Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) introduced legislation to improve clinical trials for experimental medical treatments that will ultimately save lives. 

“The long clinical trial and evaluation process prevents many Americans from getting the care they need when they need it.” Hatch said. “What’s worse, the cumbersome process discourages high-risk patients from enrolling in clinical trials, even though these are the very patients who need the treatments most. These obstacles prevent the FDA and drug manufacturers from gathering critical data, resulting in fewer treatment options for patients. Our bill seeks to correct these shortcomings by giving drug manufacturers and sponsors suggestions on how to broaden eligibility for clinical trials. This proposal will improve medical treatments by encouraging manufacturers to recruit more high-risk patients in their clinical trials. With more comprehensive data, manufacturers will be better equipped to develop drug treatments that offer hope and relief to thousands of Americans.”

“The current clinical trial process is outdated, preventing the FDA and drug manufacturers from developing critical treatments for patients who need them most,” Bennet said. “This legislation will provide needed direction to improve clinical trials by expanding eligibility to high-risk patients. It will also create a more streamlined and transparent process for patients who still don’t qualify for a clinical trial, but need access to experimental treatments.”

"I am proud to support legislation that enhances our understanding of the clinical trial process today so that Americans may benefit from new treatments and therapies in the future,” Burr said. “The new information provided by the Enhanced Clinical Trial Design Act is a step in the right direction to modernize the process that provides Americans with medicines that save and improve lives.”

"Promising new drugs brings hope to patients,” said Casey. “This legislation will take important steps to improve clinical trial enrollment and increase access to experimental drugs for the patients who are most eager to try these therapies."

Background

This bill:

  • Authorizes a public meeting between the Food and Drug Administration (FDA) and National Institutes of Health (NIH) to discuss clinical trial criteria;
  • Requires a Government Accountability Study to be completed;
  • Provides guidance about eligibility for clinical trials following the publication of study; 
  • Improves the institutional review board review of individual pediatric and adult patient expanded access protocol and how the institutional review boards may facilitate the use of the protocols;
  • Allows drug manufacturers and sponsors would make their policies available during phase 1 of study, rather than phase 2 or 3, for drugs going through the breakthrough therapy, fast track product or regenerative advanced therapy pathways.