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Outcomes for clinical trials of food allergy treatments

Outcomes for clinical trials of food allergy treatments

Authors

Kathleen Sim, MD, PhD Dragan Mijakoski, MD, PhD Sasho Stoleski, MD, PhD Pablo Rodriguez del Rio, MD, PhD Patrick Sammut, MD Thuy-My Le, MD Daniel Munblit, MD, PhD Robert J. Boyle, MD, PhD

Abstract 

Objective: Food allergy is a common condition that can have a significant impact on the quality of life of affected individuals and their caregivers. Recent years have witnessed an increased effort to identify new treatments for food allergy. Here, we review the need to identify core outcomes for measurement in clinical trials of food allergy treatments.

Data Sources: We reviewed the literature regarding core outcome set development, the important role that these play in prioritizing patient-relevant outcomes, and the potential for core outcomes to accelerate the path to product marketing by allowing prompt and reliable evidence synthesis after trial publication.

Study Selection: We reviewed recent clinical trials of food allergy treatments to understand which outcomes have previously been measured, and also reviewed available core outcome set initiatives for other allergic conditions to understand which other outcomes might be explored in future trials.

Results: Clinical trials of food allergy treatments have largely focused on outcomes that are relevant to investigators and commercial investors, especially the threshold of reactivity and immunologic changes. Future trials should consider addressing patient-important outcomes and should report the experiences of both adult and child participants and their caregivers.

Conclusion: There is a pressing need for core outcome set development for food allergy treatment trials.

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