Innovations in Clinical Trials and Research Data Management

Medical Extended Reality Trials: Building Robust Comparators, Controls, and Sham

Susan Persky, Luana Colloca

J Med Internet Res 2023 (Nov 22); 25:e45821

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The Roles of Electronic Health Records for Clinical Trials in Low- and Middle-Income Countries: Scoping Review

Jiancheng Ye, Shangzhi Xiong, Tengyi Wang, Jingyi Li, Nan Cheng, Maoyi Tian, Yang Yang

JMIR Med Inform 2023 (Nov 22); 11:e47052

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Methods for the Clinical Validation of Digital Endpoints: Protocol for a Scoping Review Abstract

Sílvia Rego, Ana Rita Henriques, Sofia Silvério Serra, Teresa Costa, Ana Maria Rodrigues, Francisco Nunes

JMIR Res Protoc 2023 (Oct 26); 12:e47119

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Internet-Based Recruitment and Retention of Young Adults With Type 1 Diabetes: Cross-Sectional Study

Stephanie Griggs, Garrett I Ash, Grant Pignatiello, AnnMarie Papik, Johnathan Huynh, Mary Leuchtag, Ronald L Hickman Jr

JMIR Form Res 2023 (Aug 22); 7:e46415

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Targeted Glioblastoma Treatment via Synthesis and Functionalization of Gold Nanoparticles With De Novo–Engineered Transferrin-Like Peptides: Protocol for a Novel Method

Augusto Müller Fiedler, Michelle Medeiros, Haidi Dalinda Fiedler

JMIR Res Protoc 2023 (Aug 11); 12:e49417

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Developing a Core Outcome Set for Assessing Clinical Safety Outcomes of Prostate Cancer in Clinical Trials of Traditional Chinese Medicine: Protocol for a Mixed Methods Study

Huichuan Tian, Yao Zhang, Jiajun Ren, Chaoran Wang, Ruiyu Mou, Xiaojiang Li, Yingjie Jia

JMIR Res Protoc 2023 (Aug 07); 12:e46794

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Reducing Clinical Trial Monitoring Resources and Costs With Remote Monitoring: Retrospective Study Comparing On-Site Versus Hybrid Monitoring

Zhiying Fu, Xiaohong Liu, Shuhua Zhao, Yannan Yuan, Min Jiang

J Med Internet Res 2023 (Jun 27); 25:e42175

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Establishing Requirements for Technology to Support Clinical Trial Retention: Systematic Scoping Review and Analysis Using Self-determination Theory

Eoin Gamble, Conor Linehan, Ciara Heavin

J Med Internet Res 2023 (Apr 13); 25:e38159

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Direct-to-Consumer Recruitment Methods via Traditional and Social Media to Aid in Research Accrual for Clinical Trials for Rare Diseases: Comparative Analysis Study

Janelle Applequist, Cristina Burroughs, Peter A Merkel, Marc Rothenberg, Bruce Trapnell, Robert Desnick, Mustafa Sahin, Jeffrey Krischer

J Med Internet Res 2023 (Mar 14); 25:e39262

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The Effects of Exergaming on Executive and Physical Functions in Older Adults With Dementia: Randomized Controlled Trial

Shanshan Wu, Hongqing Ji, Junyeon Won, Eun-Ah Jo, Yun-Sik Kim, Jung-Jun Park

J Med Internet Res 2023 (Mar 07); 25:e39993

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Web-Based System to Capture Consistent and Complete Real-world Data of Physical Therapy Interventions Following Total Knee Replacement: Design and Evaluation Study

Patricia D Franklin, Carol A Oatis, Hua Zheng, Marie D Westby, Wilfred Peter, Jeremie Laraque-Two Elk, Joseph Rizk, Ellen Benbow, Wenjun Li

JMIR Rehabil Assist Technol 2022 (Oct 27); 9(4):e37714

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Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Nachiket Gudi, Prashanthi Kamath, Trishnika Chakraborty, Anil G Jacob, Shradha S Parsekar, Suptendra Nath Sarbadhikari, Oommen John

J Med Internet Res 2022 (May 04); 24(5):e33591

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Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals

Kai Fitzer, Renate Haeuslschmid, Romina Blasini, Fatma Betül Altun, Christopher Hampf, Sherry Freiesleben, Philipp Macho, Hans-Ulrich Prokosch, Christian Gulden

JMIR Med Inform 2022 (Apr 20); 10(4):e28696

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Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies: Systematic Review

Iredia M Olaye, Mia P Belovsky, Lauren Bataille, Royce Cheng, Ali Ciger, Karen L Fortuna, Elena S Izmailova, Debbe McCall, Christopher J Miller, Willie Muehlhausen, Carrie A Northcott, Isaac R Rodriguez-Chavez, Abhishek Pratap, Benjamin Vandendriessche, Yaara Zisman-Ilani, Jessie P Bakker

J Med Internet Res 2022 (Apr 14); 24(4):e33537

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Cocreating a Harmonized Living Lab for Big Data–Driven Hybrid Persona Development: Protocol for Cocreating, Testing, and Seeking Consensus

Teemu Santonen, Despoina Petsani, Mikko Julin, Markus Garschall, Johannes Kropf, Vicky Van der Auwera, Sylvie Bernaerts, Raquel Losada, Rosa Almeida, Jokin Garatea, Idoia Muñoz, Eniko Nagy, Eva Kehayia, Elaine de Guise, Sylvie Nadeau, Nancy Azevedo, Sofia Segkouli, Ioulietta Lazarou, Vasileia Petronikolou, Panagiotis Bamidis, Evdokimos Konstantinidis

JMIR Res Protoc 2022 (Jan 06); 11(1):e34567

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The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study

Dinesh Pal Mudaranthakam, Alexandra Brown, Elizabeth Kerling, Susan E Carlson, Christina J Valentine, Byron Gajewski

JMIR Form Res 2021 (Dec 22); 5(12):e30368

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Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed Methods, Community-Engaged Study

Jerome T Galea, Karah Y Greene, Brandon Nguyen, Andrea N Polonijo, Karine Dubé, Jeff Taylor, Christopher Christensen, Zhiwei Zhang, Brandon Brown

JMIR Res Protoc 2021 (Nov 23); 10(11):e33608

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Transforming Anesthesia Data Into the Observational Medical Outcomes Partnership Common Data Model: Development and Usability Study

Antoine Lamer, Osama Abou-Arab, Alexandre Bourgeois, Adrien Parrot, Benjamin Popoff, Jean-Baptiste Beuscart, Benoît Tavernier, Mouhamed Djahoum Moussa

J Med Internet Res 2021 (Oct 29); 23(10):e29259

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ClinicalTrials.gov as a Source of Information About Expanded Access Programs: Cohort Study

Jan Borysowski, Andrzej Górski

J Med Internet Res 2021 (Oct 28); 23(10):e26890

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A Patient-Screening Tool for Clinical Research Based on Electronic Health Records Using OpenEHR: Development Study

Mengyang Li, Hailing Cai, Shan Nan, Jialin Li, Xudong Lu, Huilong Duan

JMIR Med Inform 2021 (Oct 21); 9(10):e33192

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