Innovations in Clinical Trials and Research Data Management

Exploring Methods to Mitigate Fraud in Web-Based Surveys: Multicase Study Analysis

Madeleine Ennis, Regina-Maria Renner, Claudia Morando-Stokoe, Sharon James, Patricia A Janssen, Sara Leckie, Sheila Dunn, Danielle Mazza, Wendy V Norman

J Med Internet Res 2025 (Dec 01); 27:e78671

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Web-Based Platform for the Chilean Cardiac Surgery Registry: Algorithm Development and Validation Study

Sergio Guinez-Molinos, Enrique Seguel, Jaime Gonzalez, Benjamin Castillo

JMIR Cardio 2025 (Nov 11); 9:e70147

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Lessons Learned Identifying and Controlling Fraudulent Participation in Online Randomized Trials

Robert Siebers, Kara M Magane, Hattie Slayton, Skylar Karzhevsky, Tibor P Palfai, Ana M Abrantes, Lisa M Quintiliani, Michael D Stein

J Med Internet Res 2025 (Oct 29); 27:e77512

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Clinical Trial Schedule of Activities Specification Using Fast Healthcare Interoperability Resources Definitional Resources: Mixed Methods Study

Andrew Richardson, Patrick Genyn

JMIR Med Inform 2025 (Oct 20); 13:e71430

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Large Language Models for Automating Clinical Trial Criteria Conversion to Observational Medical Outcomes Partnership Common Data Model Queries: Validation and Evaluation Study

Kye Hwa Lee, Sujung Jang, Grace Juyun Kim, Sukyoung Park, Doeun Kim, Oh Jin Kwon, Jae-Ho Lee, Young-Hak Kim

JMIR Med Inform 2025 (Oct 16); 13:e71252

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Privacy-by-Design Approach to Generate Two Virtual Clinical Trials for Multiple Sclerosis and Release Them as Open Datasets: Evaluation Study

Stanislas Demuth, Olivia Rousseau, Igor Faddeenkov, Julien Paris, Jérôme De Sèze, Béatrice Baciotti, Marianne Payet, Morgan Guillaudeux, Alban-Félix Barreteau, David Laplaud, Gilles Edan, Pierre-Antoine Gourraud

J Med Internet Res 2025 (Oct 01); 27:e71297

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Using Large Language Models to Assess the Consistency of Randomized Controlled Trials on AI Interventions With CONSORT-AI: Cross-Sectional Survey

Xufei Luo, Zeming Li, Zhenhua Yang, Bingyi Wang, Yanfang Ma, Fengxian Chen, Qi Wang, Long Ge, James Zou, Lu Zhang, Yaolong Chen, Zhaoxiang Bian

J Med Internet Res 2025 (Sep 26); 27:e72412

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Reflections on the Optimal Use of eDiaries for Data Collection in Vaccine Clinical Trials

Ujwani Nukala, Sylvia Cho, Aneesha Suresh Sahu, Jessica Zhou, Whitney R Steele, Barbee I Whitaker, Hussein Ezzeldin

J Med Internet Res 2025 (Sep 19); 27:e66971

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Enhancing Clinical Data Management Through Barcode Integration and Research Electronic Data Capture: Scalable and Adaptable Implementation Study

Rendong Zhang, Sophie Chiron, Regina Tyree, Kate Carson, Larry Raber, Karthik Ramadass, Chenyu Gao, Michael E Kim, Lianrui Zuo, Yike Li, Zhiyu Wan, Paul A Harris, Qi Liu, Ken S Lau, Lori A Coburn, Keith T Wilson, Yuankai Huo, Bennett A Landman, Shunxing Bao

JMIR Form Res 2025 (Sep 12); 9:e70016

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Improving Patient Engagement in Phase 2 Clinical Trials With a Trial-Specific Patient Decision Aid: Development and Usability Study

Iva Halilaj, Relinde Lieverse, Cary Oberije, Lizza Hendriks, Charlotte Billiet, Ines Joye, Brice Van Eeckhout, Anke Wind, Anshu Ankolekar, Philippe Lambin

J Med Internet Res 2025 (Sep 10); 27:e71817

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Large Language Models in Randomized Controlled Trials Design: Observational Study

Liyuan Jin, Jasmine Chiat Ling Ong, Kabilan Elangovan, Yuhe Ke, Alexandra Pyle, Daniel Shu Wei Ting, Nan Liu

J Med Internet Res 2025 (Sep 03); 27:e67469

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Automated Data Harmonization in Clinical Research: Natural Language Processing Approach

Pratheek Mallya, Ricardo Henao, Chuan Hong, Daniel Wojdyla, Tony Schibler, Vihaan Manchanda, Michael Pencina, Jennifer Hall, Juan Zhao

JMIR Form Res 2025 (Aug 27); 9:e75608

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Using the ATra Black Box to Improve Public Health Data Linkages and Analytics in the DC Cohort Longitudinal HIV Study: Viewpoint on the Process and Findings

Anne Giuranna Rhodes, Maria Jaurretche, Lisa Mele, Daniel Jarris, Paige Kulie, Shannon Barth, Miranda Smith, J Smart, Amanda D Castel, DC Cohort Executive Committee

J Med Internet Res 2025 (Aug 14); 27:e77119

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Resolving Challenges in HIV Cure–Related Research: Protocol for a Modified Delphi Consensus-Building Process

John Sauceda, Anastasia Korolkova, Lidia Rodriguez Garcia, Bridgette Picou, Ali Ahmed, Karine Dubé

JMIR Res Protoc 2025 (Aug 06); 14:e67123

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Enhancing Clinical Data Infrastructure for AI Research: Comparative Evaluation of Data Management Architectures

Richard Gebler, Ines Reinecke, Martin Sedlmayr, Miriam Goldammer

J Med Internet Res 2025 (Aug 01); 27:e74976

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Advancing the Integration of Digital Health Technologies in the Drug Development Ecosystem

Sakshi Sardar, Cheryl D Coon, Scottie Kern, Huong Huynh, Diane Stephenson, Joshua Rubin Abrams, Grace V Lee, Cecile Ollivier, Joseph A Hedrick, Martijn LTM Müller, Luc J W Evers, Lada Leyens, Collin Hovinga, Shu Chin Ma, Klaus Romero

J Med Internet Res 2025 (Jul 31); 27:e67052

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Leveraging Interoperable Electronic Health Record (EHR) Data for Distributed Analyses in Clinical Research: Technical Implementation Report of the HELP Study

Julia Palm, Kutaiba Saleh, André Scherag, Danny Ammon

JMIR Med Inform 2025 (Jul 30); 13:e68171

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Standardizing Survey Data Collection to Enhance Reproducibility: Development and Comparative Evaluation of the ReproSchema Ecosystem

Yibei Chen, Dorota Jarecka, Sanu Ann Abraham, Remi Gau, Evan Ng, Daniel M Low, Isaac Bevers, Alistair Johnson, Anisha Keshavan, Arno Klein, Jon Clucas, Zaliqa Rosli, Steven M Hodge, Janosch Linkersdörfer, Hauke Bartsch, Samir Das, Damien Fair, David Kennedy, Satrajit S Ghosh

J Med Internet Res 2025 (Jul 11); 27:e63343

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Adaptation of Clinical Research Staff to Decentralized Clinical Trials and Impacts on the Patient-Centered Experience: Qualitative Interview Study

Eoin Gamble, Ciara Heavin, Conor Linehan

J Med Internet Res 2025 (Jun 16); 27:e62947

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Seek and Ye Shall Not Find (Yet): Searching Clinical Trial Registries for Trials Designed With Patients—A Call to Action

Karen Louise Woolley, JD Woolley, Mark James Woolley

J Particip Med 2025 (May 30); 17:e72015

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