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The Beyond Celiac Coalition

Accelerating clinical trials in celiac disease by addressing major patient barriers

Coalition Objectives:

  • Identify significant roadblocks to the diagnosis and treatment of celiac disease.
  • Address major patient barriers to accelerate clinical trials for celiac disease.


  • Increase and accelerate patient enrollment
  • Address the value of histology in clinical trial development
  • Standardize the gluten challenge
  • Expand clinical trials network
  • Validate prognostic and diagnostic biomarkers
  • Develop best practices to increase clinical trial diversity
  • Increase pediatric opportunities
  • Better utilize real-world evidence
  • Provide enhanced testing for non-celiac gluten sensitivity

Current Priorities:

  • Systematic analysis of barriers to and facilitators of celiac disease patient engagement in clinical research E.g. recruitment, retention, patient and site perspectives. Focus groups, shared clinical trial data etc.
  • Create celiac disease clinical trial guidance for pediatric and/or adult centers By CeD sub-population, synthesize best practices to address barriers (e.g. toolkit, publications). Prep new sites and improve existing sites.

Since 2003, Beyond Celiac has been the leading patient advocacy and research-driven celiac disease organization working to drive diagnosis, advance research and accelerate the discovery of new treatments and a cure.

Now, Beyond Celiac has brought together members of academia, key opinion leaders, government agencies, and pharmaceutical, biotech and diagnostic companies to identify and address significant roadblocks to the diagnosis and treatment of celiac disease.


Our Coalition structure includes an Executive Board to set the vision, strategic priorities and oversee the use of funds, plus a Steering Committee to provide recommendations on project priorities and plans. The Beyond Celiac Coalition is operated and funded by annual membership dues, with projects funded from supplemental funds members provide. Membership benefits include seats on the Executive Board and/or Steering Committee. Participation in project funding is based on the discretion of each potential project participant, with project funding opportunities offered to all members.

Member Benefits:

  • Play a role in shaping best practices and accelerating celiac disease clinical trials
  • Gain knowledge and insights that will help advance business decisions Leverage resources in a pre-competitive environment
  • Gain access to shared data
  • Contribute to celiac disease science and the expansion of the clinical trials network
  • Have the opportunity to work collaboratively, both in person and remotely, with other members of the Beyond Celiac Coalition
  • Receive frequent communications on the latest science/trends

Contact Chief Advancement Officer Mary Kate Carofano at [email protected] to learn more about membership opportunities. 

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