Active, not recruiting

Semantic Data Quality Standards for Multi-Center Clinical Research Studies and Networks

Posted on by Jodi Snare

Page last updated May 11, 2026

Study Design: Other, Methods to improve study design, methods to support data research networks
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement, Clinical Research Collaboration Agreement
Principal Investigator: L. Charles Bailey
Institution: The Children's Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2021
Study Duration: 2021 – 2026
Participating PCORnet® Clinical Research Networks: PEDSnet
Therapeutic Area: Data Science
Condition: Data quality assessment, data quality analysis, data quality reporting, standards development
Status: Active, not recruiting

Research Question(s):

  1. Can we find ways to more accurately describe how suitable data are to answer a specific research question?
  2. What are the tools that can be used across studies to consistently describe whether the data are high quality?

Primary Publication(s):

Razzaghi H, Dickinson K, Wieand K, et al. A multifaceted approach to advancing data quality and fitness standards in multi-institutional networks. J Am Med Inform Assoc. 2025;ocaf181. doi:10.1093/jamia/ocaf181

Razzaghi H, Wieand K, Dickinson KL, et al. Beyond missingness: systematizing methods for comprehensive data fitness assessment in clinical research. J Med Internet Res. 2026;28(1):e76398. Published April 14, 2026.
doi.org/10.2196/76398

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

ACTIV-6: COVID-19 Study of Repurposed Medications

Posted on by Jodi Snare

Page last updated May 11, 2026

ClinicalTrials.gov#: NCT04885530
Study Design: Intervention Trial
PCORnet Infrastructure: Single IRB, Patient partners or engagement
Principal Investigator: Adrian Hernandez
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Federal (NIH)
Funding Date: 2021
Study Duration: 2021 – 2025
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19
Age Range: 30 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):
Can repurposed medications reduce symptoms of non-hospitalized participants with mild to moderate COVID-19?

Primary Publication(s):

Naggie S, Boulware DR, Lindsell CJ, et al. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022;328(16):1595–1603. doi:10.1001/jama.2022.18590

McCarthy MW, Naggie S, Boulware DR, et al. Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(4):296–305. doi:10.1001/jama.2022.24100

Naggie S, Boulware DR, Lindsell CJ, et al. Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(11):888–897. doi:10.1001/jama.2023.1650

Biologic Abatement and Capturing Kids’ Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)

Posted on by Jodi Snare

Page last updated May 11, 2026

Study Website: The BACK-OFF JSpA Study
ClinicalTrials.gov#: NCT04891640
Study Design: Intervention Trial
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Pamela F. Weiss
Institution: The Children's Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2020
Study Duration: 2021 – 2026
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, STAR
Therapeutic Area: Autoimmune (Allergy & Immunology), Spondyloarthritis
Condition: Juvenile Spondyloarthritis
Age Range: 8 Years to 21 Years (Child,  Adult)
Status: Active, not recruiting

Research Question(s):

This trial will compare how patients with inactive spondyloarthritis on tumor necrosis factor inhibitor (TNFi) treatment respond to three treatment options that doctors currently use:

  • Continue standard TNFi medication,
  • Space out the time between usual TNFi medication doses, or
  • Stop the TNFi medication. If we can safely prolong the time between doses or completely take away TNFi therapy in this population, we may remove unnecessary medication exposure, improve patient quality of life, and lower medication costs.