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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04263727
Other study ID # TARGET-RWE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 27, 2020
Est. completion date February 2035

Study information

Verified date August 2023
Source Target PharmaSolutions, Inc.
Contact Jenna Brininger
Phone 757-469-2574
Email jbrininger@targetrwe.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100000
Est. completion date February 2035
Est. primary completion date February 2035
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Locations

Country Name City State
United States University of Michigan Allergy Specialty Clinic & Food Allergy Ann Arbor Michigan
United States St. Francis Medical Institute Clearwater Florida
United States Asthma and Allergy Associates, PC Colorado Springs Colorado
United States Family Allergy & Asthma Research Institution Louisville Kentucky
United States Coastal Carolina Healthcare, P.A. New Bern North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Target PharmaSolutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Natural history of chronic disease under study: Characteristics of chronic diseases under study. Up to 10 years
Primary Natural history of chronic disease under study: Participant demographics Up to 10 years
Primary Natural history of chronic disease under study: Treatment use Up to 10 years
Primary Natural history of chronic disease under study: Disease progression Up to 10 years
Primary Adverse event frequency and severity Up to 10 years
Secondary Natural history of chronic disease under study: Treatment response Up to 10 years
Secondary Time point of clinical response Every 12 months for 10 years
Secondary Reasons for treatment discontinuation Up to 10 years
Secondary Self-reported patient health measures: Asthma Control Test Every 12 months for 10 years
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