Clinical Trials in Inflammatory Diseases: From Organ-Targeted to Mechanism of Action-Targeted Therapies

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Chronic inflammatory diseases primarily caused by dysregulation of the immune system include a broad range of pathologies affecting different organs and functions, such as musculoskeletal, gastrointestinal, endocrine and neurological diseases. The incidence and prevalence of inflammatory diseases, as well as their associated healthcare costs have been growing, and are expected to increase further in the next few years.

The therapeutic approach to this class of diseases has changed dramatically in the last 20 years moving from a predominantly symptomatic treatment targeting affected organs to a therapeutic strategy targeting the underlying etiological mechanism with the purpose of inducing remission and preventing further organ damage. The knowledge of the crucial role of immunology and inflammation in the disease etiological processes has led to the discovery of multiple targets for anti-inflammatory treatment. Since apparently unrelated diseases can share the same inflammatory pathway, their treatment can take advantage of the same therapeutic agent exerting its action on the common altered mechanism.

The clinical development of these types of medications requires a different approach. In fact, due to a potentially broad spectrum of therapeutic indications for the same drug, planning clinical development requires informed decisions regarding the most adequate human models for proof-of-concept studies and the therapeutic to pursue in pivotal confirmatory studies. Executing trials in inflammatory diseases presents specific challenges common to this heterogeneous group across different therapeutic areas, including use of subjective measures and composite indices for disease evaluation, need for sensitive patient reported outcome (PRO) tools and for patient’s diary, and endpoint management. In addition, study investigators must control for a number of potentially biasing factors such as background therapy, placebo effect, variability in standard of care and disease severity, or strict control on eligibility of patients.

After participating in this webinar, you will:

  • Understand more about anti-inflammatory drugs targeting specific inflammatory pathways that are common to different inflammatory diseases
  • Be able to better identify and navigate common challenges across different therapeutic indications presented by clinical trials of anti-inflammatory drugs
  • Develop and execute the right clinical trial procedures to solve these challenges in inflammatory indications
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