Innovations in Clinical Trials and Research Data Management

Studies of Artificial Intelligence/Machine Learning Registered on ClinicalTrials.gov: Cross-Sectional Study With Temporal Trends, 2010-2023

Shoko Maru, Michael D Matthias, Ryohei Kuwatsuru, Ross J Simpson Jr

J Med Internet Res 2024 (Oct 25); 26:e57750

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Trial Factors Associated With Completion of Clinical Trials Evaluating AI: Retrospective Case-Control Study

David Chen, Christian Cao, Robert Kloosterman, Rod Parsa, Srinivas Raman

J Med Internet Res 2024 (Sep 23); 26:e58578

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Data Integrity Issues With Web-Based Studies: An Institutional Example of a Widespread Challenge

Blandine French, Camilla Babbage, Katherine Bird, Lauren Marsh, Mirabel Pelton, Shireen Patel, Sarah Cassidy, Stefan Rennick-Egglestone

JMIR Ment Health 2024 (Sep 16); 11:e58432

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Research Into Digital Health Intervention for Mental Health: 25-Year Retrospective on the Ethical and Legal Challenges

Charlotte L Hall, Aislinn D Gómez Bergin, Stefan Rennick-Egglestone

J Med Internet Res 2024 (Sep 09); 26:e58939

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Promoting Collaborative Scholarship During the COVID-19 Pandemic Through an Innovative COVID-19 Data Explorer and Repository at Yale School of Medicine: Development and Usability Study

Angela Maria Victoria-Castro, Tanima Arora, Michael Simonov, Aditya Biswas, Jameel Alausa, Labeebah Subair, Brett Gerber, Andrew Nguyen, Allen Hsiao, Richard Hintz, Yu Yamamoto, Robert Soufer, Gary Desir, Francis Perry Wilson, Merceditas Villanueva

JMIR Form Res 2024 (Sep 03); 8:e52120

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The Digital Platform and Its Emerging Role in Decentralized Clinical Trials

Rachel R Copland, Sten Hanke, Amy Rogers, Lampros Mpaltadoros, Ioulietta Lazarou, Alexandra Zeltsi, Spiros Nikolopoulos, Thomas M MacDonald, Isla S Mackenzie

J Med Internet Res 2024 (Sep 03); 26:e47882

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Provenance Information for Biomedical Data and Workflows: Scoping Review

Kerstin Gierend, Frank Krüger, Sascha Genehr, Francisca Hartmann, Fabian Siegel, Dagmar Waltemath, Thomas Ganslandt, Atinkut Alamirrew Zeleke

J Med Internet Res 2024 (Aug 23); 26:e51297

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Data Collection and Management of mHealth, Wearables, and Internet of Things in Digital Behavioral Health Interventions With the Awesome Data Acquisition Method (ADAM): Development of a Novel Informatics Architecture

I Wayan Pulantara, Yuhan Wang, Lora E Burke, Susan M Sereika, Zhadyra Bizhanova, Jacob K Kariuki, Jessica Cheng, Britney Beatrice, India Loar, Maribel Cedillo, Molly B Conroy, Bambang Parmanto

JMIR Mhealth Uhealth 2024 (Aug 07); 12:e50043

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Ethical, Legal, and Practical Concerns Surrounding the Implemention of New Forms of Consent for Health Data Research: Qualitative Interview Study

Svenja Wiertz, Joachim Boldt

J Med Internet Res 2024 (Aug 07); 26:e52180

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Making Metadata Machine-Readable as the First Step to Providing Findable, Accessible, Interoperable, and Reusable Population Health Data: Framework Development and Implementation Study

David Amadi, Sylvia Kiwuwa-Muyingo, Tathagata Bhattacharjee, Amelia Taylor, Agnes Kiragga, Michael Ochola, Chifundo Kanjala, Arofan Gregory, Keith Tomlin, Jim Todd, Jay Greenfield

Online J Public Health Inform 2024 (Aug 01); 16:e56237

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Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study

Anna G M Zondag, Marieke J Hollestelle, Rieke van der Graaf, Hendrik M Nathoe, Wouter W van Solinge, Michiel L Bots, Robin W M Vernooij, Saskia Haitjema, UCC-CVRM study group

J Med Internet Res 2024 (Jul 11); 26:e54867

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Data Flow Construction and Quality Evaluation of Electronic Source Data in Clinical Trials: Pilot Study Based on Hospital Electronic Medical Records in China

Yannan Yuan, Yun Mei, Shuhua Zhao, Shenglong Dai, Xiaohong Liu, Xiaojing Sun, Zhiying Fu, Liheng Zhou, Jie Ai, Liheng Ma, Min Jiang

JMIR Med Inform 2024 (Jun 27); 12:e52934

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Remote Inclusion of Vulnerable Users in mHealth Intervention Design: Retrospective Case Analysis

Ingjerd J Straand, Kimberley A Baxter, Asbjørn Følstad

JMIR Mhealth Uhealth 2024 (Jun 14); 12:e55548

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Combating Fraudulent Participation in Urban American Indian and Alaska Native Virtual Health Research: Protocol for Increasing Data Integrity in Online Research (PRIOR)

Nicole D Reed, Sheana Bull, Umit Shrestha, Michelle Sarche, Carol E Kaufman

JMIR Res Protoc 2024 (Jun 13); 13:e52281

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Evaluating the Problem of Fraudulent Participants in Health Care Research: Multimethod Pilot Study

Vithusa Kumarasamy, Nicole Goodfellow, Era Mae Ferron, Amy L Wright

JMIR Form Res 2024 (Jun 04); 8:e51530

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Identifying Existing Guidelines, Frameworks, Checklists, and Recommendations for Implementing Patient-Reported Outcome Measures: Protocol for a Scoping Review

Randi Thisakya Jayasinghe, Susannah Ahern, Ashika D Maharaj, Lorena Romero, Rasa Ruseckaite

JMIR Res Protoc 2024 (May 21); 13:e52572

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Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study

Yan Jia, Qi Li, Xiaowen Zhang, Yi Yan, Shiyan Yan, Shunping Li, Wei Li, Xiaowen Wu, Hongguo Rong, Jianping Liu

J Med Internet Res 2024 (May 08); 26:e45719

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Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned

Sara Shaw Green, Sung-Jae Lee, Samantha Chahin, Meardith Pooler-Burgess, Monique Green-Jones, Sitaji Gurung, Angulique Y Outlaw, Sylvie Naar

JMIR Form Res 2024 (May 02); 8:e46420

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Psychotherapy for Ketamine’s Enhanced Durability in Chronic Neuropathic Pain: Protocol for a Pilot Randomized Controlled Trial

Akash Goel, Bhavya Kapoor, Hillary Chan, Karim Ladha, Joel Katz, Hance Clarke, Janneth Pazmino-Canizares, Zaaria Thomas, Kaylyssa Philip, Gabriella Mattina, Paul Ritvo

JMIR Res Protoc 2024 (Apr 17); 13:e54406

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Investigating the Roles and Responsibilities of Institutional Signing Officials After Data Sharing Policy Reform for Federally Funded Research in the United States: National Survey

Jinyoung Baek, Jonathan Lawson, Vasiliki Rahimzadeh

JMIR Form Res 2024 (Mar 20); 8:e49822

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