Asthma, Chronic Obstructive Pulmonary Disease, COPD, Idiopathic Pulmonary Fibrosis, IPF, Respiratory Disease
Conditions
Keywords
IPF, COPD, Respiratory Disease, Asthma
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Target PharmaSolutions, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Adults and children being managed or treated for a chronic disease under study. Diagnosis is based on the clinical judgement of the care provider. * Patient is anticipated to have continued management of their chronic disease at the participating site.
Exclusion criteria
* Inability to provide informed assent/consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event frequency and severity | Up to 10 years |
| Natural history of chronic disease under study: Characteristics of chronic diseases under study. | Up to 10 years |
| Natural history of chronic disease under study: Participant demographics | Up to 10 years |
| Natural history of chronic disease under study: Treatment use | Up to 10 years |
| Natural history of chronic disease under study: Disease progression | Up to 10 years |
Secondary
| Measure | Time frame |
|---|---|
| Time point of clinical response | Every 12 months for 10 years |
| Reasons for treatment discontinuation | Up to 10 years |
| Self-reported patient health measures: Asthma Control Test | Every 12 months for 10 years |
| Natural history of chronic disease under study: Treatment response | Up to 10 years |
Countries
United States
Outcome results
None listed