Kate Fultz Hollis

BACKGROUND Clinical Research Informatics (CRI) has evolved rapidly with advances in artificial intelligence (AI), expanding real-world data (RWD) platforms, and equity-focused approaches, yet persistent challenges, such as low participation in clinical trials, remain. In fast-moving fields like CRI, a Year-in-Review (YIR) provides a timely, expert-driven synthesis of recent high-impact contributions, helping the informatics and clinical research communities track emerging methods, infrastructure, and implementation gaps. OBJECTIVE To identify and synthesize recent advances in CRI published between January 2023 and August 2025. The review aims to highlight high-impact developments that shape the evolving landscape of CRI, with particular attention to emerging methods, data infrastructures, and applications influencing the design, conduct, and analysis of clinical research. METHODS This narrative review by the AMIA CRI Working Group synthesizes high-impact 2023–2025 literature via expert selection and AI-assisted thematic analysis. PubMed served as the primary database, supplemented by selective Google Scholar searches and curated journal alerts. Reviewers were blinded to other reviewers’ reviews and followed identical screening and scoring methods in phases using defined scoring rubrics. Secondly, AI-assisted thematic analysis was used to identify patterns using an additional scoring system to extract keywords, generate codes, and group articles into themes. Human reviewer feedback and expert adjudication refined keywords, codes, and thematic groupings generated by AI-supported analysis. Articles with the highest composite scores were selected for inclusion in the YIR. RESULTS After screening and prioritization across three review phases, the search yielded 891 articles. Seven prioritized articles highlight three themes: AI-enhanced trial matching/recruitment, maturation of large-scale RWD infrastructures for evidence generation, and informatics strategies for health equity and patient engagement. Noted themes, including slow progress in efficiency and infrastructure, persisted alongside challenges in equity and implementation. CONCLUSIONS The synthesis created with the 2025 Year-in-Review provides an overview of the most influential developments shaping the current trajectory of CRI. Major advances include AI-driven clinical trial optimization, RWD infrastructures, and equity-focused CRI. Despite improvements in efficiency and scale, significant challenges in implementation and inclusive participation persist, and multidisciplinary efforts will be essential to produce more representative and actionable clinical evidence. CLINICALTRIAL NA

Generative artificial intelligence (AI) systems have performed well at many biomedical tasks, but few studies have assessed their performance directly compared to students in higher-education courses. We compared student knowledge-assessment scores with prompting of 6 large-language model (LLM) systems as they would be used by typical students in a large online introductory course in biomedical and health informatics that is taken by graduate, continuing education, and medical students. The state-of-the-art LLM systems were prompted to answer multiple-choice questions (MCQs) and final exam questions. We compared the scores for 139 students (30 graduate students, 85 continuing education students, and 24 medical students) to the LLM systems. All of the LLMs scored between the 50^th and 75^th percentiles of students for MCQ and final exam questions. The performance of LLMs raises questions about student assessment in higher education, especially in courses that are knowledge-based and online.

AMIA has a longstanding interest and a professional obligation to promote a strong ethical framework for its members and the field of biomedical and health informatics. This white paper presents the latest AMIA Code of Professional and Ethical Conduct. The original code was approved in 2007 ¹ by the AMIA Board of Directors and revised in 2013. ² Recognizing the need to regularly update the Code to ensure that it remains current and relevant, we present this document that constitutes a revision of and update to the third version, approved and published in the Journal of the American Medical Informatics Association in 2018. ³ The code presented here remains an evolving document, with modifications expected as information technology, informatics, policy, and health care environments change over time. AMIA publishes on its web site the most recent version of the Code of Ethics as part of a process that seeks ongoing response from and involvement by AMIA members.

Editors: Kate Fultz Hollis Oregon Health & Science University Portland, OR, USA fultzhol@ohsu.edu Fleur Mougin University of Bordeaux & BPH UMR_S 1219 Bordeaux, France Fleur.Mougin@u-bordeaux.fr Lina F. Soualmia Normandie University, UNIROUEN, LITIS Rouen, France Lina.Soualmia@chu-rouen.fr Editorial Assistant: Martina Hutter Heidelberg University Hospital Heidelberg, Germany yearbook@imia-services.org Best Papers Editor: Adrien Ugon ESIEE Paris & LIP6 UMR_7606 adrien.ugon@esiee.fr Advisory Board: Reinhold Haux Peter L. Reichertz Institute for Medical Informatics of TU Braunschweig and Hannover Medical School Braunschweig, Germany reinhold.haux@plri.de Victor Maojo Universidad Politécnica de Madrid Departamento de Inteligencia Artificial Facultad de Informatica Madrid, Spain vmaojo@fi.upm.es George Mihalas University of Medicine and Pharmacy Dept. of Medical Informatics Timisoara, Romania mihalas@EFMI.info Section Editors: Christian Baumgartner Graz University of Technology Graz, Austria christian.baumgartner@tugraz.at Mary Lauren Benton Baylor University Waco, TX, USA marylauren_benton@baylor.edu Eta S. Berner Department of Health Services Administration University of Alabama at Birmingham Birmingham, AL, USA eberner@uab.edu Meryl Bloomrosen mbloomrosen@google.com Damian Borbolla Department of Biomedical Informatics University of Utah Salt Lake City, UT, USA damian.borbolla@utah.edu Georgeta Bordea University of Bordeaux & BPH UMR_S 1219 Bordeaux, France georgeta.bordea@u-bordeaux.fr Jean Charlet DRCI/AP-HP & LIMICS UMR_S 1142 Paris, France jean.charlet@sorbonne-universite.fr Tiago Colicchio University of Alabama at Birmingham, AL, USA tiagokc@uab.edu Licong Cui The University of Texas Health Science Center at Houston Houston, TX, USA Licong.Cui@uth.tmc.edu Christel Daniel WIND-DSI/AP-HP & LIMICS UMR_S 1142 Paris, France christel.daniel@aphp.fr Thomas M. Deserno Peter L. Reichertz Institute for Medical Informatics of TU Braunschweig and Hannover Medical School Braunschweig, Germany thomas.deserno@plri.de Ferdinand Dhombres Sorbonne University & LIMICS UMR_S 1142 Trousseau Hospital, AP-HP Paris, France ferdinand.dhombres@aphp.fr Gayo Diallo University of Bordeaux & BPH UMR_S 1219 Bordeaux, France gayo.diallo@u-bordeaux.fr Brian E. Dixon Indiana University Fairbanks School of Public Health & Regenstrief Institute Indianapolis, IN, USA bedixon@regenstrief.org Natalia Grabar CNRS, Univ. Lille, UMR 8163 STL - Savoirs Textes Langage Lille, France natalia.grabar@univ-lille.fr Cyril Grouin Université Paris-Saclay, CNRS, LISN Orsay, France cyril.grouin@lisn.upsaclay.fr Werner Hackl UMIT TIROL - Private University for Health Sciences and Health Technology Hall in Tirol, Austria werner.hackl@umit-tirol.at Alexander Hoerbst MCI - The Entrepreneurial School Innsbruck, Austria alexander.hoerbst@mci.edu John H. Holmes University of Pennsylvania PerelmanSchool of Medicine Philadelphia, PA, USA jhholmes@pennmedicine.upenn.edu Dipak Kalra The University of Gent Gent, Belgium dipak.kalra@i-hd.eu Annie Y. S. Lau Centre for Health Informatics Australian Institute of Health Innovation Macquarie University, Australia annie.lau@mq.edu.au Scott McGrath University of California Berkeley Missoula, USA smcgrath@berkeley.edu Debra Patt Texas Oncology Austin, TX, USA debra.patt@usoncology.com Michael Rooney Department of Radiation Oncology MD Anderson Cancer Center Houston, TX, USA mkrooney@mdanderson.org Yalini Senathirajah University of Pittsburgh School of Medicine Pittsburgh, USA yalini@pitt.edu Anthony Solomonides NorthShore University HealthSystem Evanston, Illinois, USA tony.solomonides@gmail.com Pascal Staccini IRIS Department, Lab RETINES Faculté de Médecine, Université Côte d’Azur Nice, France pascal.staccini@univ-cotedazur.fr X. Tannier Sorbonne Université Université Sorbonne Paris Nord, INSERM, LIMICS Paris, France xavier.tannier@sorbonne-universite.fr Jeremy Warner Lifespan Cancer Institute Providence, RI, USA jeremy_warner@brown.edu Regional Editors: Naoki Nakashima APAMI nnaoki@med.kyushu-u.ac.jp Ghislain B. Kouematchoua Tchuitcheu HELINA gkouema@gmail.com Marcelo Silva IMIA-LAC marcelo.silva@sbis.org.br Najeeb Al-Shorbaji MENAHIA shorbajin@gmail.com James J. Cimino AMIA Birmingham, AL, USA ciminojj@gmail.com Andre Kushniruk Digital Health Canada: Canada’s Health Informatics Association Toronto, ON, Canada andrek@uvic.ca Lacramioara Stoicu-Tivadar EFMI lacramioara.stoicu-tivadar@upt.ro IMIA Executive Director: Elaine Huesing imia@imia-services.org Article published online: 04 December 2022 © 2022. IMIA and Thieme. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/) Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany

A discussion and debate on the American Medical Informatics Association’s (AMIA) Ethical, Legal, and Social Issues (ELSI) Working Group listserv in 2021 raised important issues related to a forthcoming conference in Texas. Texas had recently enacted a restrictive abortion law and restricted voting rights. Several AMIA members advocated for a boycott of the state and the scheduled conference. The discussion led the AMIA Board of Directors to request that the organization’s Ethics Committee provide general guidance for principle-based venue selection. This document recommends overarching principles for the venue selection for future AMIA events and conferences. Discussions by the AMIA Board, the Ethics Committee, and the ELSI Working Group informed these recommendations, and this document on guiding principles was approved by the AMIA Board of Directors in April 2022.

The Text REtrieval Conference (TREC), co-sponsored by the National Institute of Standards and Technology (NIST) in the US and US Department of Defense, was started in 1992. TREC's purpose is to support research within the information retrieval community by providing the infrastructure necessary for large-scale evaluation of text retrieval methodologies. In 2017, the TREC Precision Medicine (Roberts et al., 2017) track grew from the Clinical Decision Support track and focused on a narrower problem domain of precision oncology. After three years of computer runs being evaluated for relevance by physician readers, we provide a unique perspective of how to evaluate computer-generated articles and clinical trials pulled from PubMed and Clinicaltrials.gov to find relevant information on medical cases.

Background: The role of the Chief Research Informatics Officer (CRIO) is emerging in academic health centers to address the challenges clinical researchers face in the increasingly digitalized, data-intensive healthcare system. Most current CRIOs are the first officers in their institutions to hold that role. To date there is very little published information about this role and the individuals who serve it. Objective: To increase our understanding of the CRIO role, the leaders who serve it, and the factors associated with their success in their organizations. Methods: The Clinical Research Informatics Working Group of the American Medical Informatics Association (AMIA) conducted a national survey of CRIOs in the United States and convened an expert panel of CRIOs to discuss their experience during the 2016 AMIA Annual Symposium. Results: CRIOs come from diverse academic backgrounds. Most have advance training and extensive experience in biomedical informatics but the majority have been CRIOs for less than three years. CRIOs identify funding, data governance, and advancing data analytics as their major challenges. Conclusion: CRIOs play an important role in helping shape the future of clinical research, innovation, and data analytics in healthcare in their organizations. They share many of the same challenges and see the same opportunities for the future of the field. Better understanding the background and experience of current CRIOs can help define and develop the role in other organizations and enhance their influence in the field of research informatics. Citation: Sanchez-Pinto LN, Mosa ASM, Fultz-Hollis K, Tachinardi U, Barnett WK, Embi PJ. The Emerging Role of the Chief Research Informatics Officer in Academic Health Centers. Appl Clin Inform 2017; 8: 845–853 https://doi.org/10.4338/ACI-2017-04-RA-0062 ^* For the Clinical Research Informatics Working Group of the American Medical Informatics Association. Clinical Relevance Statement The role of the Chief Research Informatics Officer (CRIO) is emerging in academic health centers to address the challenges clinical researchers face in the increasingly digitalized, data-intensive healthcare system. To date there has been very little published information about this role and the individuals who serve it. Better understanding the background and experience of current CRIOs can help define and develop the role in other organizations and enhance their influence in the future of research informatics. Human Subjects Protections The study was performed in compliance with the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, and was reviewed by the University of Missouri-Columbia and The University of Chicago Institutional Review Boards.

The Health Information Technology for Economic and Clinical Health (HITECH) Act proposes the meaningful use of interoperable electronic health records throughout the United States health care delivery system as a critical national goal. As we have moved from medical records on paper to interoperable electronic health records, the rapid and easy sharing of medical data through the Internet makes medical data insecure. Electronic data is easy to share but many steps to ensure security of the data need to be taken. Beyond medical data security, we need to ethically acquire, use and manage data so that all people involved with the data from producer to data manager are recognized and respected. This paper advocates that sharing medical data can be ethically the right choice for everyone in health care if data sharing guidelines are available for people to use, modify and strengthen for specific purposes.