Irl B Hirsch1, Joe Martinez2, E Ray Dorsey3, Gerald Finken4, Alexander Fleming5, Chris Gropp6, Philip Home7, Daniel I Kaufer8, Spyros Papapetropoulos9. 1. University of Washington, Seattle, Washington. 2. Center Point Clinical Services, Malvern, Pennsylvania. Electronic address: jbmartinez56@gmail.com. 3. University of Rochester Medical Center, Rochester, New York. 4. CSM, Fargo, North Dakota. 5. Kinexum, Harper's Ferry, West Virginia. 6. Trialogics, Wilmington, Delaware. 7. Newcastle University, Newcastle upon Tyne, United Kingdom. 8. University of North Carolina, Chapel Hill, North Carolina. 9. TEVA Pharmaceuticals, Boston, Massachusetts.
Abstract
PURPOSE: Options for leveraging available telemedicine technologies, ranging from simple webcams and telephones to smartphone apps and medical-grade wearable sensors, are evolving faster than the culture of clinical research. Until recently, most clinical trials relied on paper-based processes and technology. This cost- and labor-intensive system, while slowly changing, remains an obstacle to new drug development. Alternatives that use existing tools and processes for collecting real-world data in home settings warrant closer examination. METHODS: The site-less clinical research organization (CRO) model, whereby pharmacists or other health care professionals provide useful and timely counseling for protocol compliance by regular phone and videoconferencing sessions, is a flexible approach to managing clinical trial participants directly from their homes. An expert panel, including clinical specialists in metabolic or neurodegenerative diseases, health information technology and CRO innovators, and the pharmaceutical industry, met in Dallas, Texas, December 2016, to discuss advancing avenues for site-less CRO and other remote clinical trial practices, taking into account investigator, sponsor, and regulatory perspectives. FINDINGS: Real-time "site-less" management of clinical trials can augment traditional research and development methods by providing data from a broader, more diverse group of patients in real-world practice settings. This methodology also helps to proactively identify safety profile and operational issues. Current use of site-less CRO practices constitutes an important bridge to alternative trial models, including "large simple trials" that strive to answer one or two questions using data derived from representative patient populations treated in typical clinical settings. IMPLICATIONS: Site-less CROs offer a working example of how remote technologies and in-home monitoring methods can address shortcomings of conventional drug development. This model maximizes time and cost, as well as potentially earlier identification of adverse events. Coordinated communication among investigators, sponsors, regulators, and patients will be needed to develop standardized strategies for incorporating site-less CROs into current and future study design.
PURPOSE: Options for leveraging available telemedicine technologies, ranging from simple webcams and telephones to smartphone apps and medical-grade wearable sensors, are evolving faster than the culture of clinical research. Until recently, most clinical trials relied on paper-based processes and technology. This cost- and labor-intensive system, while slowly changing, remains an obstacle to new drug development. Alternatives that use existing tools and processes for collecting real-world data in home settings warrant closer examination. METHODS: The site-less clinical research organization (CRO) model, whereby pharmacists or other health care professionals provide useful and timely counseling for protocol compliance by regular phone and videoconferencing sessions, is a flexible approach to managing clinical trial participants directly from their homes. An expert panel, including clinical specialists in metabolic or neurodegenerative diseases, health information technology and CRO innovators, and the pharmaceutical industry, met in Dallas, Texas, December 2016, to discuss advancing avenues for site-less CRO and other remote clinical trial practices, taking into account investigator, sponsor, and regulatory perspectives. FINDINGS: Real-time "site-less" management of clinical trials can augment traditional research and development methods by providing data from a broader, more diverse group of patients in real-world practice settings. This methodology also helps to proactively identify safety profile and operational issues. Current use of site-less CRO practices constitutes an important bridge to alternative trial models, including "large simple trials" that strive to answer one or two questions using data derived from representative patient populations treated in typical clinical settings. IMPLICATIONS: Site-less CROs offer a working example of how remote technologies and in-home monitoring methods can address shortcomings of conventional drug development. This model maximizes time and cost, as well as potentially earlier identification of adverse events. Coordinated communication among investigators, sponsors, regulators, and patients will be needed to develop standardized strategies for incorporating site-less CROs into current and future study design.
Authors: Mark Forrest Gordon; Igor D Grachev; Itzik Mazeh; Yonatan Dolan; Ralf Reilmann; Pippa S Loupe; Shai Fine; Leehee Navon-Perry; Nicholas Gross; Spyros Papapetropoulos; Juha-Matti Savola; Michael R Hayden Journal: Digit Biomark Date: 2019-09-06
Authors: Srikanth Muppidi; Richard J Nowak; Amanda C Guidon; Jeffrey T Guptill; Michael K Hehir; Katherine Ruzhansky; Leeann B Burton; David Post; Gary Cutter; Robin Conwit; Nicte I Mejia; Henry J Kaminski; James F Howard Journal: Muscle Nerve Date: 2021-07-07 Impact factor: 3.852