Innovative Technologies in CNS Trials: Promises and Pitfalls for Recruitment, Retention, and Representativeness.

Autor:	Lutz J; Dr. Lutz was with Medical Office, Click Therapeutics, Inc. in New York, New York, at the time of writing; she is now with Biogen Digital Health in Cambridge, Massachusetts, and Boston University School of Medicine in Boston, Massachusetts., Pratap A; Dr. Pratap was with Center for Addiction & Mental Health in Toronto, Canada, at the time of writing; he is now with Boehringer Ingelheim in Ridgefield, Connecticut; King's College London in London, United Kingdom; and Department of Biomedical Informatics and Medical Education, University of Washington in Seattle, Washington., Lenze EJ; Dr. Lenze is with Department of Psychiatry, Washington University School of Medicine in St. Louis, Missouri., Bestha D; Dr. Bestha is with Atrium Health in Charlotte, North Carolina., Lipschitz JM; Dr. Lipschitz is with Brigham and Women's Hospital in Boston, Massachusetts, and Harvard Medical School in Boston, Massachusetts., Karantzoulis S; Dr. Karantzoulis is with IQVIA in New York, New York., Vaidyanathan U; Dr. Vaidyanathan was with Boehringer Ingelheim in Ridgefield, Connecticut, at the time of writing; she is now with Sublimus in Ridgefield, Connecticut., Robin J; Dr. Robin is with Winterlight Labs, Inc. in Toronto, Canada., Horan W; Dr. Horan was with WCG VeraSci in Durham, North Carolina, at the time of writing; he is now with Karuna Therapeutics in Boston, Massachusetts, and University of California in Los Angeles, California., Brannan S; Dr. Brannan is with Karuna Therapeutics in Boston, Massachusetts., Mittoux A; Dr. Mittoux is with Lundbeck in Paris, France., Davis MC; Dr. Davis is with Usona Institute in Madison, Wisconsin., Lakhan SE; Dr. Lakhan is with Medical Office, Click Therapeutics, Inc. in New York, New York, and School of Neuroscience, Virginia Tech in Blacksburg, Virginia., Keefe R; Dr. Keefe is with Department of Psychiatry, Duke University Medical Center in Durham, North Carolina.
Jazyk:	angličtina
Zdroj:	Innovations in clinical neuroscience [Innov Clin Neurosci] 2023 Sep 01; Vol. 20 (7-9), pp. 40-46. Date of Electronic Publication: 2023 Sep 01 (Print Publication: 2023).
Abstrakt:	Objective: Recruitment of a sufficiently large and representative patient sample and its retention during central nervous system (CNS) trials presents major challenges for study sponsors. Technological advances are reshaping clinical trial operations to meet these challenges, and the COVID-19 pandemic further accelerated this development. Method of Research: The International Society for CNS Clinical Trials and Methodology (ISCTM; www.isctm.org) Innovative Technologies for CNS Trials Working Group surveyed the state of technological innovations for improved recruitment and retention and assessed their promises and pitfalls. Results: Online advertisement and electronic patient registries can enhance recruitment, but challenges with sample representativeness, conversion rates from eligible prescreening to enrolled patients, data privacy and security, and patient identification remain hurdles for optimal use of these technologies. Electronic medical records (EMR) mining with artificial intelligence (AI)/machine learning (ML) methods is promising but awaits translation into trials. During the study treatment phase, technological innovations increasingly support participant retention, including adherence with the investigational treatment. Digital tools for adherence and retention support take many forms, including patient-centric communication channels between researchers and participants, real-time study reminders, and digital behavioral interventions to increase study compliance. However, such tools add technical complexities to trials, and their impact on the generalizability of results are largely unknown. Conclusion: Overall, the group found a scarcity of systematic data directly assessing the impact of technological innovations on study recruitment and retention in CNS trials, even for strategies with already high adoption, such as online recruitment. Given the added complexity and costs associated with most technological innovations, such data is needed to fully harness technologies for CNS trials and drive further adoption. Competing Interests: DISCLOSURES: Dr. Lutz may have equity interests with Click Therapeutics, Inc. Dr. Lenze has previously consulted for Merck, Prodeo, Boehringer Ingelheim, Pritikin ICR, and IngenioRx; he has previously received funding from PCORI, the COVID-19 Early Treatment Fund, Mercatus/FastGrants, and Janssen; and he has a patent pending for sigma1 receptor agonists for COVID-19 treatment. Dr. Vaidyanathan was an employee of Boehringer Ingelheim at the time of writing. Dr. Robin is an employee of Winterlight Labs, Inc. and has equity interests with Winterlight Labs, Inc. Dr. Horan was an employee of WCG VeraSci at the time of writing, and is now an employee of Karuna Therapeutics. Dr. Brannan is an employee at Karuna Therapeutics. Dr. Lakhan is employed by Click Therapeutics, Inc. and has equity interests. Dr. Keefe serves as a paid consultant to WCG, Karuna, Merck, Sunovion, Biogen, and Boehringer Ingelheim. All other authors have no conflicts of interest relevant to the contents of this article. (Copyright © 2023. Matrix Medical Communications. All rights reserved.)
Databáze:	MEDLINE
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