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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Enteral nutrition encompasses various methods of delivering nutrition directly to the gastrointestinal (GI) tract, bypassing traditional oral intake. It is particularly beneficial for patients who cannot eat by mouth but have a functioning digestive system. Key methods include nasointestinal feeding, gastrostomy, and jejunostomy, each suited to different clinical scenarios based on the patient's needs and condition.
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Related Experiment Video

Updated: Mar 25, 2026

Adapting Human Videofluoroscopic Swallow Study Methods to Detect and Characterize Dysphagia in Murine Disease Models
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Navigating Oral Food Challenges in Clinical Trials to Keep the Science Moving Forward.

Edwin H Kim1, J Andrew Bird2, Helen A Brough3,4,5

  • 1Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.

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|March 24, 2026
PubMed
Summary

Oral food challenges (OFCs) are standard for food allergy diagnosis but present limitations in clinical trials. Experts discussed optimizing OFCs and biomarkers for better therapeutic development.

Keywords:
anti‐IgEbasophil activation testbiologicalsdouble‐blind placebo‐controlled food challengefood allergyimmunotherapyoral food challenge

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Area of Science:

  • Allergy and Immunology
  • Clinical Trial Design

Background:

  • Oral food challenges (OFCs) are the gold standard for diagnosing food allergies and assessing oral tolerance.
  • OFCs are increasingly used in clinical trials for eligibility, reactivity assessment, and treatment outcomes.

Purpose of the Study:

  • To discuss the limitations of using OFCs as the sole primary metric in food allergy clinical trials.
  • To explore the role of OFCs and immunologic biomarkers in advancing therapeutic development.
  • To identify potential innovations for conducting future food allergy clinical trials.

Main Methods:

  • Convened a panel of expert allergists.
  • Discussed current and future clinical trial landscapes.
  • Evaluated the role of OFCs and immunologic biomarkers.

Main Results:

  • OFCs as sole efficacy metrics can limit representative population recruitment.
  • Arbitrary OFC reaction criteria may exclude allergic individuals and increase participant burden.
  • OFCs pose risks and unpleasant experiences for study participants.

Conclusions:

  • Rethinking the sole reliance on OFCs is crucial for inclusive and efficient food allergy clinical trials.
  • Integrating immunologic biomarkers alongside OFCs may offer a more comprehensive approach.
  • Innovations are needed to advance therapeutic development in food allergy.