Remote Monitoring and Data Collection for Decentralized Clinical Trials.

Autor:	Daly B; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, New York., Brawley OW; School of Medicine, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., Gospodarowicz MK; Princess Margaret Cancer Center, University of Toronto, Toronto, Ontario, Canada., Olopade OI; Medicine and Human Genetics, Center for Clinical Cancer Genetics and Global Health, University of Chicago Medical Center, Chicago, Illinois., Fashoyin-Aje L; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland., Smart VW; Susan G. Komen Foundation, Dallas, Texas., Chang IF; Amgen Inc, Thousand Oaks, California., Tendler CL; Janssen, Johnson & Johnson, New Brunswick, New Jersey., Kim G; BeiGene, Cambridge, Massachusetts., Fuchs CS; Genentech, South San Francisco, California.; Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut., Beg MS; Science 37, Durham, North Carolina.; Internal Medicine, Gastrointestinal Oncology, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas., Zhang L; Jiangsu Hengrui Pharmaceuticals, Shanghai, China., Legos JJ; Novartis, Basel, Switzerland., Duran CO; AstraZeneca, Cambridge, United Kingdom., Kalidas C; Bayer, Leverkusen, Germany., Qian J; Asia Society, New York, New York., Finnegan J; Bloomberg New Economy, Bloomberg LP, New York, New York., Pilarski P; McKinsey Cancer Center, McKinsey & Company, New York, New York., Keane H; McKinsey Cancer Center, McKinsey & Company, New York, New York., Shen J; McKinsey Cancer Center, McKinsey & Company, New York, New York., Silverstein A; McKinsey Cancer Center, McKinsey & Company, New York, New York., Wu YL; Guangdong Lung Cancer Institute, Chinese Thoracic Oncology Group, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China., Pazdur R; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland., Li BT; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, New York.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2024 Apr 01; Vol. 7 (4), pp. e246228. Date of Electronic Publication: 2024 Apr 01.
DOI:	10.1001/jamanetworkopen.2024.6228
Abstrakt:	Importance: Less than 5% of patients with cancer enroll in a clinical trial, partly due to financial and logistic burdens, especially among underserved populations. The COVID-19 pandemic marked a substantial shift in the adoption of decentralized trial operations by pharmaceutical companies. Objective: To assess the current global state of adoption of decentralized trial technologies, understand factors that may be driving or preventing adoption, and highlight aspirations and direction for industry to enable more patient-centric trials. Design, Setting, and Participants: The Bloomberg New Economy International Cancer Coalition, composed of patient advocacy, industry, government regulator, and academic medical center representatives, developed a survey directed to global biopharmaceutical companies of the coalition from October 1 through December 31, 2022, with a focus on registrational clinical trials. The data for this survey study were analyzed between January 1 and 31, 2023. Exposure: Adoption of decentralized clinical trial technologies. Main Outcomes and Measures: The survey measured (1) outcomes of different remote monitoring and data collection technologies on patient centricity, (2) adoption of these technologies in oncology and all therapeutic areas, and (3) barriers and facilitators to adoption using descriptive statistics. Results: All 8 invited coalition companies completed the survey, representing 33% of the oncology market by revenues in 2021. Across nearly all technologies, adoption in oncology trials lags that of all trials. In the current state, electronic diaries and electronic clinical outcome assessments are the most used technology, with a mean (SD) of 56% (19%) and 51% (29%) adoption for all trials and oncology trials, respectively, whereas visits within local physician networks is the least adopted at a mean (SD) of 12% (18%) and 7% (9%), respectively. Looking forward, the difference between the current and aspired adoption rate in 5 years for oncology is large, with respondents expecting a 40% or greater absolute adoption increase in 8 of the 11 technologies surveyed. Furthermore, digitally enabled recruitment, local imaging capabilities, and local physician networks were identified as technologies that could be most effective for improving patient centricity in the long term. Conclusions and Relevance: These findings may help to galvanize momentum toward greater adoption of enabling technologies to support a new paradigm of trials that are more accessible, less burdensome, and more inclusive.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu