Amendment Provides Opportunity for Patients to More Easily Gain Access to Potentially Beneficial Experimental Therapies While in Development

Friends of Cancer Research (Friends) would like to thank and applaud the work of Senators Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) who once again showed their tireless commitment to patients by introducing an amendment to the PDUFA VI Reauthorization bill that takes important steps in eliminating barriers to clinical trial participation. The amendment is an area of great focus for Friends and the outgrowth of a series of multi-stakeholder working groups, scientific whitepapers, and a joint effort launched in May by Friends and the American Society for Clinical Oncology (ASCO) aimed at modernizing eligibility criteria where scientifically and clinically appropriate.

“The Hatch/Bennet/Burr/Casey amendment takes important steps to make clinical trials accessible to more individuals,” said Jeff Allen, President & CEO of Friends of Cancer Research. “Clinical trials are often conducted in a narrowly defined set of patients. This amendment will spur the development of methods and study designs to broaden eligibility criteria in appropriate trials. The broadening of these criteria will allow more patients to participate in clinical studies and result in trials that may be more reflective of the patient that will ultimately use the drug once it is on the market.”

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Friends of Cancer Research (Friends) drives collaboration among partners from every healthcare sector to power advances in science, policy and regulation that speed lifesaving treatments to patients. For more information, please visit www.focr.org.