Learn about Research & Clinical Trials

A Study of Patients With Chronic Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04263727
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Target PharmaSolutions, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Asthma, Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, IPF, COPD, Respiratory Disease

Additional Details

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.

Arms & Interventions

Arms

: Asthma

Non-Interventional. Patients with asthma will be screened and enrolled into the active Asthma disease-specific cohort.

: Chronic Obstructive Pulmonary Disease (COPD)

Non-Interventional. Patients with COPD will be screened into the inactive COPD disease-specific cohort.

: Idiopathic Pulmonary Fibrosis (IPF)

Non-Interventional. Patients with IPF will be screened into the inactive IPF disease-specific cohort.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Asthma and Allergy Associates, PC, Colorado Springs, Colorado

Status

Recruiting

Address

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907

Site Contact

jbrininger@targetrwe.com

757-469-2574

St. Francis Medical Institute, Clearwater, Florida

Status

Terminated