Allergy CRO

An allergy CRO with the expertise you need

Unprecedented advances in allergy treatments – including traditional therapeutics, innovative biologics, novel immunotherapies, and optimized routes of administration – are bringing heartening news to those affected and creating exciting opportunities for drug developers. Conducting successful clinical trials, however, requires a deep understanding of best practices for each of these complex indications and their wide-ranging symptoms and causality.

For example, allergic rhinitis is typically impacted by regional differences and seasonal environments, thereby involving specialized vendors, high-touch clinical support for sites, and risk mitigation strategies.  Food allergy trials often require complex challenge procedures and rigorous safety monitoring, making early planning and site training essential for successful execution. In every case, a patient-centered approach is key to recruitment, retention, and compliance.

Our approach

At Parexel, our best practices have developed over many years of conducting clinical trials in this challenging therapeutic area. Led by a board-certified allergist-immunologist, our dedicated therapeutic area team with focused experience in allergic conditions plays an essential role on the entire path to approval, beginning with study startup – the crucial initial planning process.  We have extensive experience conducting allergy and immunology trials in both pediatric and adult populations, tailoring study designs and operational strategies to meet the unique needs of each age group.  We have executed studies across the spectrum of allergic diseases and immunodeficiencies including allergic rhinitis/rhino conjunctivitis, chronic rhinosinusitis with nasal polyps, food allergy, asthma, atopic dermatitis, urticaria, primary immunodeficiency, hereditary angioedema, and more. 

We have specialized relationships with sites equipped with environmental exposure chamber capabilities for controlled allergen-exposure studies. Our experience ranges from Early Phase trials conducted in our own Early Phase Clinical Units to complex global trials in Phases II-IV. 

CASE STUDY

Pivotal Phase III food allergy case study

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Situation

  • Phase III, randomised, pivotal trial to confirm the efficacy and safety of the study drug in food-allergic children, aged 4-11 years
  • Over 300 pediatric patients in more than 30 sites across North America, Europe and Australia

Challenges

  • Randomized short-term study, so patients not likely to experience significant/durable treatment effect  diminished incentive to participate
  • Double-blind, placebo-controlled, food challenge visits (DBPCFC) must occur within seven days of each other presented challenges – patients coming from far away
    • Illness and need for antihistamines presented issues
  • COVID-19 impact on spirometry & study drug dispensing 
  • Epi-Pen shortage
     

Solution

  • Patients guaranteed entry into a long-term, open-label extension
  • Permitted to perform DBPCFC despite recent antihistamine use if histamine skin prick test positive that morning
  • Allow short washout for diphenhydramine after first day of food challenge 
  • For patients/sites unable to perform spirometry (due to COVID-19), permit verbal history for non-asthmatics and peak flow in car or at home for asthmatics
  • Allowed direct-to-patient shipments of study drug during COVID-19
  • Allowed sites to prescribe, instead of provide, epinephrine auto-injectors (and reimburse patients) and use vials of epinephrine onsite
  • Ongoing training and staff availability to adapt to protocol changes 
     

Result

Completed all major milestones on-time including enrollment, final and interim database lock, data safety monitoring board, and interim analysis.


Experience in the past 5 years

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clinical projects
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patients
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sites