A Study of Patients With Chronic Disease

  • STATUS
    Recruiting
  • End date
    Feb 28, 2035
  • participants needed
    100000
  • sponsor
    Target PharmaSolutions, Inc.
Updated on 19 February 2024
a 10
chronic disease

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.

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.

Details
Condition Chronic Obstructive Lung Disease, Chronic Obstructive Lung Disease, Respiratory Tract Diseases, Pulmonary Fibrosis, Pulmonary Fibrosis, Respiratory disorder, Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma
Age 100years or below
Clinical Study IdentifierNCT04263727
SponsorTarget PharmaSolutions, Inc.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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