Prospective Observational

Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD

Posted on by Jodi Snare

Page last updated November 12, 2025

Study Design: Prospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement, Clinical Research Collaboration Agreement
Principal Investigator: Michael D. Kappelman
Institution: University of North Carolina at Chapel Hill
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2025
Study Duration: 2025 – 2031
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Gastroenterology
Status: Not yet recruiting

Research Question(s):

  1. Can we determine which medicine is the safest and most effective at treating kids with Crohn's disease or ulcerative colitis when the first medicine they take does not work for them?

Implementation Program to Improve Screening and management for CKD in Diabetes (IRIS-CKD)

Posted on by Jodi Snare

Page last updated May 11, 2026

ClinicalTrials.gov#: NCT06906627 - Program 1
ClinicalTrials.gov#: NCT06906640 - Program 2
Study Design: Prospective Observational Study
PCORnet Infrastructure: Patient partners or engagement
Principal Investigator: Neha Pagidipati
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Industry (Bayer, Boehringer Ingelheim, Lilly)
Funding Date: 2024
Study Duration: 2024 – 2026
Participating PCORnet® Clinical Research Networks: INSIGHT, OneFlorida+, PaTH, REACHnet, STAR 
Therapeutic Area: Nephrology
Condition: CKD in Diabetes
Status: Recruiting

Research Question(s):
IRIS-CKD is a project focused on improving how doctors check for and treat chronic kidney disease (CKD) in people with type 2 diabetes (T2D). The main goals of the project are to:

  • Increase the number of people with type 2 diabetes who get screened for chronic kidney disease.
  • Ensure that more patients with both chronic kidney disease and type 2 diabetes receive the treatments recommended by medical guidelines.

A Clinical Trial Readiness Study of Patient Reported Outcome Measures in TTP (THINK-TTP)

Posted on by Jodi Snare

Page last updated May 11, 2026

Study Design: Prospective Observational Study
PCORnet Infrastructure: Single IRB, Patient partners or engagement
Principal Investigator: Toyosi Onwuemene and Theresa Coles
Institution: Duke University
PCORnet® Network Partner: STAR
Funder: Federal (NIH/NCATS)
Funding Date: 2024
Study Duration: 2024 – 2026
Participating PCORnet® Clinical Research Networks: GPC, STAR
Therapeutic Area: Rare Diseases
Status: Active, not recruiting

Research Question(s): Can we develop a consensus-based strategy that comprehensively measures TTP-associated cognitive function impacts from the patient perspective?

Primary Publication(s):

Coles T, Mkumba L, Thompson D, et al. The THINK-TTP Study for Assessing Cognitive Function in Clinical Trials: A Qualitative Research Protocol. International Journal of Qualitative Methods. 2026;25:16094069261429876.
doi:10.1177/16094069261429876

HERO-TOGETHER: A Safety Surveillance Study of Post- Vaccination Events of Interest among People Vaccinated Against COVID-19

Posted on by Jodi Snare

Page last updated May 11, 2026

ClinicalTrials.gov#: NCT04342806
Study Design: Prospective Observational Study
PCORnet Infrastructure: Single IRB, Patient partners or engagement
Principal Investigator: Emily O'Brien
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Industry (Pfizer)
Funding Date: 2020
Study Duration: 2020 – 2022
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PaTH, REACHnet, STAR, The Coordinating Center for PCORnet®
Therapeutic Area: Infectious Disease
Status: Completed

Research Question(s): Can a research registry of people working in healthcare help to answer important questions about the COVID-19 pandemic on medications, vaccines and healthcare worker well-being?

The COVID-19 and Diabetes Assessment (CODA) Study

Posted on by Jodi Snare

Page last updated May 11, 2026

Study Website: https://codadiabetesstudy.org/ 
Study Design: Prospective Observational Study
Principal Investigator: Russell Rothman
Institution: Vanderbilt University Medical Center
PCORnet® Network Partner: STAR
Funder: Federal (NIDDK/NIH)
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: COVID-19, Diabetes
Age Range: 18 Years and older (Adult, Older Adult)
Status: Recruiting

Research Question(s):  The study will answer important questions patients are asking about the link between diabetes and COVID-19.

  1. To what extent does COVID-19 cause worse glycemic control, vascular function, inflammation, and increased risk for blood clots in people with either type 1 or type 2 diabetes?
  2. The study will also explore the role of genomic, social, and environmental factors on metabolic function and the impact of COVID-19 infection and COVID-19 treatments on diabetes-related outcomes.

Cardiovascular Multicenter Observational Investigation of Lipid Care in the United States-2 (cvMOBIUS2)

Posted on by Jodi Snare

Page last updated May 11, 2026

Study Design: Prospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigators: Eric Peterson and Ann Marie Navar
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Industry (Amgen)
Funding Date: 2021
Study Duration: 2021 - 2026
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)
Age Range: 18 Years and older (Adult, Older Adult)
Study Status: Active, not recruiting

Research Question:

Can we reduce the number of people who die from atherosclerotic cardiovascular disease (ASCVD) related deaths by using PCSK9 medicines to lower their cholesterol?

Primary Publication(s):

Navar AM, Shah NP, Shrader P, et al. Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry. Am Heart J. 2025;279:107-117. doi:10.1016/j.ahj.2024.06.012

Shoji S, Shah NP, Shrader P, et al. Achievement of guideline-based lipid goals among very-high-risk patients with atherosclerotic cardiovascular disease and type 2 diabetes: results in 213,380 individuals from the cvMOBIUS2 registry. Am J Prev Cardiol. 2024;21:100921. Published 2024 Dec 21. doi:10.1016/j.ajpc.2024.100921

Shah NP, Peterson ED, Shrader P, et al. Variation in Lipid Management for Atherosclerotic Cardiovascular Disease Across US Health Systems. Circ Popul Health Outcomes. Published online February 20, 2026. doi:10.1161/CIRCOUTCOMES.125.012622

Comparing patient-reported impact of COVID-19 shelter-in-place policies and access to containment and mitigation strategies, overall and in vulnerable populations

Posted on by Jodi Snare

Page last updated October 29, 2025

Study Website: COVID-19 Citizen Science
ClinicalTrials.gov#: NCT05548803
Study Design: Prospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Mark Pletcher
Institution: University of California, San Francisco
PCORnet® Network Partner: REACHnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (project webpage)
Funding Date: 2020
Study Duration: 2020 – 2023
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, REACHnet
Therapeutic Area: Infectious Disease
Condition: COVID-19
Age Range: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. What is the comparative impact of different shelter-in-place/reopening policies, overall and in vulnerable populations, on patient-reported financial insecurity, mental health, and other subjective outcomes important to patients?
  2. What is the comparative effectiveness of county-level containment and mitigation strategies at achieving timely access to testing, healthcare, information, and contact tracing, overall and in vulnerable populations?
  3. What is the comparative accuracy of different algorithms designed to predict risk of infection and severe COVID-19 among patients with symptoms, overall and in vulnerable populations?

Primary Publication(s):

Beatty AL, Peyser ND, Butcher XE, et al. The COVID-19 citizen science study: protocol for a longitudinal digital health cohort. JMIR Res Protoc, 2021; 10(8):e28169. doi:10.2196/28169

Neuroendocrine Tumors – Patient Reported Outcomes (NET-PRO)

Posted on by Jodi Snare

Page last updated April 14, 2026

ClinicalTrials.gov#: NCT05064150
Study Design: Prospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Michael O'Rorke
Institution: University of Iowa
PCORnet® Network Partner: GPC
Funder: Patient-Centered Outcomes Research Institute (PCORI), project website
Funding Date: 2021
Study Duration: 2021 – 2027
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, Path, STAR
Therapeutic Area: Oncology, Rare Diseases
Condition: Neuroendocrine Tumors; Gastroenteropancreatic Neuroendocrine Tumor; Lung Neuroendocrine Neoplasm; Neuroendocrine Carcinoma
Age Range: 18 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):

Which care options work, for whom, and under which circumstances in order to improve symptom management, treatment outcomes and quality of life among NET patients?

  • Common treatment combinations and their relation to disease symptoms and quality of life
  • Identification of the best ordering of treatments and relation to patient outcomes and survival
  • The impact of patient traits and tumor characteristics on treatment choice(s) and survival

Primary Publication(s):

Hourcade JP, O'Rorke M, Chrischilles E, et al. Personal Health Record Software for Neuroendocrine Tumors: Patient Centered Design Approach. JMIR Hum Factors. 2025;12:e68788. Published 2025 Jun 3. doi:10.2196/68788

Outcomes Database to Prospectively Assess Changing Therapy Landscape in Renal Cell Carcinoma (ODYSSEY RCC)

Posted on by Jodi Snare

Page last updated May 11, 2026

ClinicalTrials.gov#: NCT04919122
Study Design: Prospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigator: Dan George
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Industry (Exelixis, Bristol Myers Squibb, Merck, Pfizer)
Funding Date: 2020
Study Duration: 2022 – 2026
Participating PCORnet® Clinical Research Networks: GPC, PaTH, REACHnet, STAR
Therapeutic Area: Oncology
Condition: Metastatic Renal Cell Carcinoma
Age Range: 19 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):

  1. Can a research registry of patients with metastatic renal cell carcinoma (mRCC) patients help us better understand cancer management and health-related quality of life while receiving mRCC specific treatment? In combination with patient and physician surveys, PCORnet will be used to help us answer these questions.

Primary Publication(s):

Bhavsar NA, Harrison MR, Scales CD, et al. Design and Rationale of the Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma Registry: A Multi-institutional, Prospective Study of Patients with Metastatic Renal Cell Carcinoma. Eur Urol Open Sci. 2024;66:75-81. Published 2024 Jul 3. doi:10.1016/j.euros.2024.06.007

Pediatric KIDney Stone (PKIDS) Care Improvement Network

Posted on by Jodi Snare

Page last updated October 29, 2025

Study Website: Pediatric KIDney Stone (PKIDS) Care Improvement Network
ClinicalTrials.gov#: NCT04285658
Study Design: Prospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Gregory Tasian
Institution: The Children's Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2019
Study Duration: 2020 – 2024
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, STAR
Therapeutic Area: Nephrology
Condition: Kidney Stone; Nephrolithiasis
Age Range: 8 Years to 21 Years (Child, Adult)
Status: Completed

Research Question(s):

  1. What are the differences in stone clearance and the lived experiences of youth, age 8-21 years, following ureteroscopy (URS), shock wave lithotripsy (SWL), and percutaneous nephrolithotomy (PCNL) for the removal of kidney and ureteral stones?

Primary Publication(s):

Ellison JS, Lorenzo M, Beck H on behalf of the Pediatric KIDney Stone Care Improvement Network, et al. Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial. BMJ Open 2022;12:e056789. doi:10.1136/bmjopen-2021-056789