Innovations in Clinical Trials and Research Data Management

Digital Twins for Just-in-Time Adaptive Interventions (JITAIs): Framework for Optimizing and Continually Improving JITAIs

Asim H Gazi, Daiqi Gao, Susobhan Ghosh, Ziping Xu, Anna L Trella, Predrag Klasnja, Susan A Murphy

J Med Internet Res 2026 (Mar 06); 28:e72830

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Digitally Enhanced Routine Outcome Monitoring in Italian Psychotherapy: Protocol for a Longitudinal Implementation Study

Mattia Vincenzo Olive, Antonino La Tona, Vivian Ostwald, Agostino Brugnera, Gianluca Lo Coco, Angelo Compare, Dana Tzur Bitan, Cristina Masella

JMIR Res Protoc 2026 (Mar 02); 15:e82837

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Preventing and Treating Insomnia Symptoms in Midlife and Older Adults (ASLEEP): Protocol for a Randomized Controlled Trial Using the PROTECT Norge Infrastructure

Jon Arild Aakre, Bjørn Bjorvatn, Martha Therese Gjestsen, Ingvild Dalen, Clive Ballard, Ingelin Testad

JMIR Res Protoc 2026 (Mar 02); 15:e81542

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Comparative Evaluation of AmnioGuard and Advanced Platelet-Rich Fibrin When Combined With NovaBone Putty in the Regeneration of Human Periodontal Infrabony Defects: Protocol for a Randomized Controlled Clinical Trial

Geeta Bhandari, Priyanka Jaiswal, Shweta Bhagat, Sakshi Kotecha

JMIR Res Protoc 2026 (Feb 26); 15:e75987

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Impact of Ocular Massage on Intraocular Pressure and Schlemm Canal Dimensions in Healthy Adults: Protocol for a Randomized Controlled Trial

Mingxuan Zhang, Luning Qin, Liangzhang Tan, Yongtao Li, Qing Zhang, Shuhan Wang, Zhihui Zhang, Emmanuel Eric Pazo, Xinjun Ren

JMIR Res Protoc 2026 (Feb 26); 15:e78864

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Evaluation of Reduced Single-Photon Emission Computed Tomography Imaging Protocols and Software Variability in 177Lu-DOTATATE Dosimetry: Protocol for an Exploratory Observational Trial

Takayuki Yagihashi, Kenta Miwa, Noriaki Miyaji, Satoru Sugimoto, Hideki Hayakawa, Noritoshi Kobayashi, Shoko Takano, Taro Murai

JMIR Res Protoc 2026 (Feb 19); 15:e83248

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Real-World Effectiveness and Noninferiority Evaluation and Comparison of Messenger RNA–Based and Protein-Based COVID-19 Vaccines: Protocol for the BEEHIVE Randomized Study With a Hybrid Effectiveness Design

Sarang K Yoon, German L Ellsworth, Steph Battan-Wraith, Andrew L Phillips, Rebecca V Fink, Joshua Griffin, Elizabeth A K Rowley, Jacob McKell, Ashley S Smith, Riley Campbell, Jesse Williams, Sarah W Ball, Hongwei Zhao, Brandy Warren, Matthew D Rousculp, Matthew S Thiese

JMIR Res Protoc 2026 (Jan 27); 15:e80858

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Frameworks for Guiding the Selection of Digital Data Collection Tools Used in Clinical Trials: Protocol for a Systematic Review

Bavatharani Ananthesayanan, Kayode Philip Fadahunsi, Huanhuan Xiong, John O'Donoghue

JMIR Res Protoc 2026 (Jan 22); 15:e78529

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Leveraging AI Large Language Models for Writing Clinical Trial Proposals in Dermatology: Instrument Validation Study

Megan Hauptman, Daniel Copley, Kelly Young, Tran Do, Joseph S Durgin, Albert Yang, Jungsoo Chang, Allison Billi, Mio Nakamura, Trilokraj Tejasvi

JMIR Dermatol 2026 (Jan 12); 9:e76674

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A Real-Life Digital Intervention for Personalized Nutrition in Adults With Overweight or Obesity: Remote Randomized Controlled Trial

Jelle CBC de Jong, Femke PM Hoevenaars, Lotte GP Peters, Charlotte MM Berendsen, Wilrike J Pasman, Martien PM Caspers, Remon Dulos, Suzan Wopereis

J Med Internet Res 2026 (Jan 05); 28:e73367

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Let’s Talk aBOT Scam Online Survey Completions in Health Behavior Research: Tutorial With Case Studies, Practical Guidance, and a Checklist for Researchers

Lauren Arundell, Jo Salmon, Anthony Walsh, Kathleen Dullaghan, Heilok Cheng, Thea Baker, Megan Teychenne, Felipe Schuch, Debora Tornquist, Anna Timperio

JMIR Public Health Surveill 2025 (Dec 24); 11:e76622

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Community Advisors’ Effect on a Randomized Pragmatic Clinical Trial for Asthma Treatment: Retrospective Analysis

Wilson D Pace, Barbara Yawn, Nancy E Maher, Brianna Ericson, Elizabeth W Staton, Paulina Arias Hernandez, Bonnie Telon Sosa, Jean Kruse, Elliot Israel

J Particip Med 2025 (Dec 19); 17:e84679

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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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