Trials / Terminated
TerminatedNCT04263727
A Study of Patients With Chronic Disease
A Longitudinal Observational Study of Patients With Chronic Disease
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 579 (actual)
- Sponsor
- Target PharmaSolutions, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2020-02-27
- Primary completion
- 2024-11-21
- Completion
- 2024-11-21
- First posted
- 2020-02-11
- Last updated
- 2025-04-03
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04263727. Inclusion in this directory is not an endorsement.