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NCCS Offers Policy Comments: Strategies for Increasing Patient Participation in FDA Review Activities

December 9, 2014/in Cancer News, Cancer Policy Blog, FDA, NCCS News, Policy Comments Access to Care, Clinical Trials NCCS News, Policy Comments /by actualize

The Food and Drug Administration Safety and Innovation Act (FDASIA) authorized a patient-focused drug development program, and in the years since enactment, the U.S. Food and Drug Administration (FDA) has implemented certain initiatives of the patient-focused program. In recent weeks, FDA has requested feedback regarding patient-focused activities to date and recommendations about future efforts and NCCS was pleased to submit comments.

NCCS commends the FDA for including patient representatives on advisory committees and including periods of public comment but notes that the participation of the public is encouraged too late in the drug development and review process. In our comments, we advise the FDA to engage with patients earlier in the development process so it can better leverage the insights and experience of patients and patient advocates.

In addition, we commend the agency for being diligent in managing conflicts of interest to promote transparency regarding the relationships that patients and patient advocates have with product sponsors, but we are concerned that the current standards for determining conflicts of interest might block patient participation in FDA activities. We recommend a public discussion regarding the current application of the rules take place to better examine the issue.

Tags: Cancer Survivorship, clinical trials, FDA, policy comments, quality
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  • About
    • Our Mission
    • Our History
    • Our Leadership
      • Policy Advisors
    • Employment
    • Partnerships
    • Financial Information
  • Policy
    • Quality Cancer Care
    • Access to Care
    • Health Equity
    • Redefining Functional Status (RFS)
    • 2020 State of Cancer Survivorship Survey
    • Cancer Care Planning and Communications Act (CCPCA)
  • Get Involved
    • What is Advocacy?
    • Cancer Policy and Advocacy Team (CPAT)
    • Elevating Survivorship
    • Survivor Stories
    • Cancerversary
    • State Based Cancer Advocacy
  • Resources
    • Survivorship Checklist
    • Cancer Survival Toolbox
    • Telehealth
    • Publications
      • Talking With Your Doctor
      • Self Advocacy
      • Employment Rights
      • Remaining Hopeful
    • Taking Charge of Your Care
    • Care Planning for Cancer Survivors
    • Tools For Care Providers
    • COVID-19 Resources for Cancer Survivors
    • Order Our Resources
  • News
    • Cancer Convos Podcast
  • Events
    • Ellen L. Stovall Award
      • 2020 Stovall Awards
      • Honorees
      • Sponsors
      • Committees
      • Reception
      • Nominations
    • Cancer Policy Roundtable
      • Fall 2020 Cancer Policy Roundtable
      • Spring 2020 Cancer Policy Roundtable
    • Cancer Policy and Advocacy Team (CPAT) Symposium 2020
    • Webinars
  • Contact Us

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Harmar Brereton, MD

Founder
Northeast Regional Cancer Institute

 

“Perhaps one of the most impactful collaborations in Dr. Brereton’s extraordinary career remains his early work and long friendship with Ellen Stovall. Through him, and in turn through the thousands of lives he has touched, Ellen’s work continues, and her mission lives on.”

—Karen M. Saunders
President, Northeast Regional Cancer Institute