Expertise in Respiratory Clinical Trials

Respiratory Disorders

Understanding the Unique Challenges in Respiratory Clinical Research

At Worldwide Clinical Trials, our experts understand that the commercial viability of therapeutics for chronic respiratory disorders is influenced by a range of factors, including perceived value and therapeutic novelty. This has particular relevance to illnesses with established pharmacotherapy such as asthma and COPD. Worldwide Clinical Trails’ philosophy of employing expert clinical trial methodology, combined with our commitment to innovation, helps us deliver data relevant to multiple stakeholder perspectives and appropriate to each phase of your drug or device development. Our close relationships with opinion leaders and practitioners in respiratory medicine ensure that complex study objectives and eligibility criteria evolve into a plan that delivers reliable metrics, consistently met timelines, and impeccable data. Our team has success in overcoming the unique challenges in conducting trials in respiratory disorders, including for example, determining the allergic status of patients with asthma and managing co-morbidity often associated with COPD.

Our Experience in the Study of Respiratory Diseases and Disorders

Worldwide has participated in the design, execution, or analysis for more than 100 trials in respiratory diseases and disorders since 2008. For these studies, we provided a wide range of services, such as clinical monitoring or project management services. Of these, the majority were in Chronic Obstructive Pulmonary Disease (16 studies), Asthma (14 studies), and Cystic Fibrosis (10 studies). Our experts have managed studies with a variety of therapeutic interventions, such as corticosteroids, bronchodilators, antibiotics, and kinase inhibitors.

Capabilities of the Worldwideclinical operations staffspecific to respiratory diseases and disorders include:

  • Extensive training on both medical and operational aspects of respiratory disorders.
  • Experience in various scales and measures commonly used in respiratory diseases, including measures of pulmonary function (e.g., FEV1 and forced vital capacity (FVC) evaluated via spirometry), and Patient Reported Outcome instruments (e.g., St George’s Respiratory Questionnaire (SGRQ) and Quality of Life Short Form 36 (SF-36)).
  • Success in overcoming unique challenges in conducting trials in respiratory diseases, for example, understanding the importance of the use of centralized spirometry and operational implications.
  • Extensive practical knowledge of the impact of local clinical management practices and EC/IRB conventions on study design and implementation (e.g., access to principal investigators, knowledge regarding standard of care, and local
    reimbursement conventions).
  • Completion of numerous phase I clinical trials for steroid inhalation compounds, as well as both short-acting and longacting bronchodilators on asthma and allergy compounds.
  • Expertise in the area of bioequivalence, requiring very accurate and consistent dose administration and multiple time-point blood sample collection for pharmacokinetic (PK) assessments.

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