TARGET-RWE is a 10-year, international, longitudinal, observational study of patients with chronic disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. The protocol will follow a master protocol design in which a shared study infrastructure supports progressive development of the registry across the spectrum of chronic diseases.
The TARGET-RWE master protocol design allows shared study parameters and operational components to be organized within a centralized platform. Utilizing this platform, therapeutic area-aligned Communities with associated Disease-Specific Cohorts (DSC) can be added according to scientific merit and need to address specific research questions in patients diagnosed with chronic diseases. This design capitalizes on a shared, sustainable infrastructure across a diverse patient population, which allows for more efficient coordination and conduct than can be achieved in traditional stand-alone, independently-conducted research studies with narrowly-focused target patient populations. This master protocol design will ultimately support a dynamic program that adapts to the changing landscape of chronic disease management and allows for rapid enrollment and collection of retrospective and long-term prospective data from participants in specific disease areas of interest. TARGET-RWE currently includes the TARGET-RWE.LUNG Community, with open DSCs for Asthma, COPD and Idiopathic Pulmonary Fibrosis.
Study Type
OBSERVATIONAL
Enrollment
579
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
St. Francis Medical Institute
Clearwater, Florida, United States
Family Allergy & Asthma Research Institution
Louisville, Kentucky, United States
University of Michigan Allergy Specialty Clinic & Food Allergy
Ann Arbor, Michigan, United States
Natural history of chronic disease under study: Characteristics of chronic diseases under study.
Time frame: Up to 10 years
Natural history of chronic disease under study: Participant demographics
Time frame: Up to 10 years
Natural history of chronic disease under study: Treatment use
Time frame: Up to 10 years
Natural history of chronic disease under study: Disease progression
Time frame: Up to 10 years
Adverse event frequency and severity
Time frame: Up to 10 years
Natural history of chronic disease under study: Treatment response
Time frame: Up to 10 years
Time point of clinical response
Time frame: Every 12 months for 10 years
Reasons for treatment discontinuation
Time frame: Up to 10 years
Self-reported patient health measures: Asthma Control Test
Time frame: Every 12 months for 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Coastal Carolina Healthcare, P.A.
New Bern, North Carolina, United States