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. 2024 Apr 1;7(4):e246228.
doi: 10.1001/jamanetworkopen.2024.6228.

Remote Monitoring and Data Collection for Decentralized Clinical Trials

Bobby Daly  1 , Otis W Brawley  2 , Mary K Gospodarowicz  3 , Olufunmilayo I Olopade  4 , Lola Fashoyin-Aje  5 , Victoria Wolodzko Smart  6 , I-Fen Chang  7 , Craig L Tendler  8 , Geoffrey Kim  9 , Charles S Fuchs  10   11 , Muhammad Shaalan Beg  12   13 , Lianshan Zhang  14 , Jeffrey J Legos  15 , Cristina Ortega Duran  16 , Chitkala Kalidas  17 , Jing Qian  18 , Justin Finnegan  19 , Piotr Pilarski  20 , Harriet Keane  20 , Johanna Shen  20 , Amy Silverstein  20 , Yi-Long Wu  21 , Richard Pazdur  5 , Bob T Li  1
Affiliations

Remote Monitoring and Data Collection for Decentralized Clinical Trials

Bobby Daly et al. JAMA Netw Open. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Daly reported receiving personal fees from Varian Medical Systems during the conduct of the study and being a founding member of the Bloomberg New Economy International Cancer Coalition (unpaid). Dr Olopade reported being cofounder of CancerIQ and receiving other support from Tempus SAB and grants from Color Genomics Research Support and Roche/Genentech outside the submitted work. Dr Kim reported holding patent US11393566B1 for an interoperable platform for reducing redundancy in medical database management. Dr Fuchs reported receiving personal fees from CytomX Therapeutics and being founder of EvolveImmune Therapeutics outside the submitted work. Dr Beg reported receiving personal fees from Ipsen, Seagen, and Foundation Medicine outside the submitted work. Mr Qian reported receiving grants from AstraZeneca during the conduct of the study. Drs Keane, Pilarski, and Silverstein and Ms Shen are consultants with McKinsey & Company, Inc, a global consulting firm that provides services broadly across private, public, and not-for-profit clients, including in the life sciences and health care industries. Dr Wu reported receiving grants from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Jiangsu Hengrui Pharmaceuticals, and Roche; personal fees from AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Pfizer, and Roche; and lecture fees from Sanofi outside the submitted work. Dr Li reported receiving a research project grant and clinical trials funding to his institution from the National Institutes of Health, Amgen, AstraZeneca, Bolt Biotherapeutics, Daiichi Sankyo, Genentech, Jiangsu Hengrui Pharmaceuticals, and Eli Lilly and travel support from Amgen outside the submitted work; holding patents for Memorial Sloan Kettering Cancer Center; being a senior fellow on global health for the Asia Society Policy Institute (unpaid); and being a founding member of the Bloomberg New Economy International Cancer Coalition (unpaid). No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Respondent Adoption Rate of Remote Monitoring and Data Collection Technologies in All Clinical Trials, Including Oncology Trials, Compared With Oncology-Only Trials
The data take into consideration adoption in registrational clinical trials only. eCOA indicates electronic clinical outcome assessment; eDiary, electronic diary.
Figure 2.
Figure 2.. Current Adoption Rate of Remote Monitoring and Data Collection Technologies in Oncology Trials Compared With Average Aspired Adoption Rate in 5 Years
The data take into consideration adoption in registrational clinical trials only. eCOA indicates electronic clinical outcome assessment; eDiary, electronic diary.
See this image and copyright information in PMC

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