Innovations in Clinical Trials and Research Data Management

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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Augmenting Engagement in Decentralized Clinical Trials for Atrial Fibrillation: Development and Implementation of a Programmatic Architecture

Toluwa Daniel Omole, Andrew Mrkva, Danielle Ferry, Erin Shepherd, Jessica Caratelli, Noah Davis, Richmond Akatue, Timothy Bickmore, Michael K Paasche-Orlow, Jared W Magnani

JMIR Cardio 2025 (May 12); 9:e66436

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Clinical Laboratory Parameter–Driven Machine Learning for Participant Selection in Bioequivalence Studies Among Patients With Gastric Cancer: Framework Development and Validation Study

Byungeun Shon, Sook Jin Seong, Eun Jung Choi, Mi-Ri Gwon, Hae Won Lee, Jaechan Park, Ho-Young Chung, Sungmoon Jeong, Young-Ran Yoon

JMIR AI 2025 (May 05); 4:e64845

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Real-Time, Risk-Based Clinical Trial Quality Management in China: Development of a Digital Monitoring Platform

Min Jiang, Shuhua Zhao, Yun Mei, Zhiying Fu, Yannan Yuan, Jie Ai, Yuan Sheng, Ying Gong, Jingjing Chen

JMIR Med Inform 2025 (Apr 25); 13:e64114

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Data Interoperability in Context: The Importance of Open-Source Implementations When Choosing Open Standards

Daniel Kapitan, Femke Heddema, André Dekker, Melle Sieswerda, Bart-Jan Verhoeff, Matt Berg

J Med Internet Res 2025 (Apr 15); 27:e66616

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Approach to Design and Evaluate Digital Tools to Enhance Young Adult Participation in Clinical Trials: Co-Design and Controlled Intercept Study

Tim Mackey, Raphael E Cuomo, Qing Xu, Tiana J McMann, Zhuoran Li, Mingxiang Cai, Christine Wenzel, Joshua S Yang

J Med Internet Res 2025 (Apr 11); 27:e70852

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Long-Term Experiences of Health Care Providers Using Iris Scanning as an Identification Tool in a Vaccine Trial in the Democratic Republic of the Congo: Qualitative Study

Trésor Zola Matuvanga, Antea Paviotti, Freddy Bikioli Bolombo, Gwen Lemey, Ynke Larivière, Maha Salloum, Bernard Isekah Osang'ir, Emmanuel Esanga Longomo, Solange Milolo, Junior Matangila, Vivi Maketa, Patrick Mitashi, Pierre Van Damme, Hypolite Muhindo-Mavoko, Jean-Pierre Van geertruyden

JMIR Form Res 2025 (Mar 06); 9:e54921

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Improving the User Interface and Guiding the Development of Effective Training Material for a Clinical Research Recruitment and Retention Dashboard: Usability Testing Study

Leah Leslie Gardner, Pezhman Raeisian Parvari, Mark Seidman, Richard J Holden, Nicole R Fowler, Ben L Zarzaur, Diana Summanwar, Cristina Barboi, Malaz Boustani

JMIR Form Res 2025 (Feb 24); 9:e66718

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A 4-Site Public Deliberation Project on the Acceptability of Youth Self-Consent in Biomedical HIV Prevention Trials: Assessment of Facilitator Fidelity to Key Principles

Claire Burke Draucker, Andrés Carrión, Mary A Ott, Ariel I Hicks, Amelia Knopf

JMIR Form Res 2025 (Feb 13); 9:e58451

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Proposal and Strategy for Nursing-Led Research: Protocol for an Unfunded Clinical Trial

Leticia Carmen Simón-López, Ismael Ortuño-Soriano, Raquel Luengo-González, Paloma Posada-Moreno, Ignacio Zaragoza-García, Rubén Sánchez-Gómez

JMIR Res Protoc 2025 (Feb 10); 14:e56062

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Data-Sharing Statements Requested from Clinical Trials by Public, Environmental, and Occupational Health Journals: Cross-Sectional Study

Yingxin Liu, Jingyi Zhang, Lehana Thabane, Xuerui Bai, Lili Kang, Gregory Y H Lip, Harriette G C Van Spall, Min Xia, Guowei Li

J Med Internet Res 2025 (Feb 07); 27:e64069

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