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Incorporating Site-Less Clinical Trials Into Drug Development: A Framework for Action

Lookup NU author(s): Emeritus Professor Philip Home



This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


© 2017 The Authors.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.

Publication metadata

Author(s): Hirsch IB, Martinez J, Dorsey ER, Finken G, Fleming A, Gropp C, Home P, Kaufer DI, Papapetropoulos S

Publication type: Article

Publication status: Published

Journal: Clinical Therapeutics

Year: 2017

Volume: 39

Issue: 5

Pages: 1064-1076

Print publication date: 01/05/2017

Online publication date: 14/04/2017

Acceptance date: 22/03/2017

Date deposited: 02/05/2017

ISSN (print): 0149-2918

ISSN (electronic): 1879-114X

Publisher: Elsevier


DOI: 10.1016/j.clinthera.2017.03.018


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