Thursday, September 19, 2019

Thursday, September 19, 2019

EndBrainCancer Initiative urges support, offers amendments


New guidelines proposed by the Food and Drug Administration are receiving support by the EndBrainCancer Initiative (EBCI). The new guidelines focus on diversity in clinical trials.

EBCI, however, does propose a change to the guidelines which would allow brain cancer patients and others with rare diseases to meet with advocacy oriented outside “Patient Partners Navigation Services”.

"The EndBrainCancer Initiative (EBCI) fully supports FDA's efforts to broaden eligibility criteria for enrollment into clinical trials and increase enrollment of underrepresented populations," said Dellann Elliott Mydland, president and CEO of EBCI. "Currently an estimated only 3% of brain cancer patients enroll in trials. As an organization, our aim is to increase that significantly through immediate access and decreased barriers."

EBCI wants all patients to have access to all treatment options, including clinical trials.

"Brain cancer and rare disease patients want immediate access to the most advanced knowledge, specialists, devices, diagnostics, treatments, and the best potential clinical trials possible,” Mydland said. “We believe offering patients access to outside Patient Partner Navigation Services will help ensure the best opportunity for greater diversity and greater numbers of patients participating in clinical trials and ultimately, increased survivorship."

The EBCI has a direct connect program that has connected patients directly to clinical trials. It hopes the FDA will also propose a program such as the one the EBCI adopted.

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