Remote Monitoring and Data Collection for Decentralized Clinical Trials

被引：9

作者：

Daly, Bobby ^{[1
,3
,4
]}

Brawley, Otis W. ^{[5
]}

Gospodarowicz, Mary K. ^{[6
]}

Olopade, Olufunmilayo I. ^{[7
]}

Fashoyin-Aje, Lola ^{[8
]}

Smart, Victoria Wolodzko ^{[9
]}

Chang, I-Fen ^{[10
]}

Tendler, Craig L. ^{[11
]}

Kim, Geoffrey ^{[12
]}

Fuchs, Charles S. ^{[13
,14
]}

Beg, Muhammad Shaalan ^{[15
,16
]}

Zhang, Lianshan ^{[17
]}

Legos, Jeffrey J. ^{[18
]}

Duran, Cristina Ortega ^{[19
]}

Kalidas, Chitkala ^{[20
]}

Qian, Jing ^{[21
]}

Finnegan, Justin ^{[22
]}

Pilarski, Piotr ^{[23
]}

Keane, Harriet ^{[23
]}

Shen, Johanna ^{[23
]}

Silverstein, Amy ^{[23
]}

Wu, Yi-Long ^{[24
]}

Pazdur, Richard ^{[8
]}

Li, Bob T. ^{[2
,3
,4
]}

机构：

[1] Thorac Oncol Serv, 530 E 74th St, New York, NY 10021 USA

[2] Mem Sloan Kettering Canc Ctr, 530 E 74th St, New York, NY 10021 USA

[3] Mem Sloan Kettering Canc Ctr, Dept Med, New York, NY 10021 USA

[4] Weill Cornell Med, New York, NY USA

[5] Sch Med, Johns Hopkins Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD USA

[6] Univ Toronto, Princess Margaret Canc Ctr, Toronto, ON, Canada

[7] Univ Chicago, Ctr Clin Canc Genet & Global Hlth, Med Ctr, Med & Human Genet, Chicago, IL USA

[8] US FDA, Oncol Ctr Excellence, Silver Spring, MD USA

[9] Susan G Komen Fdn, Dallas, TX USA

[10] Amgen Inc, Thousand Oaks, CA USA

[11] Janssen Johnson & Johnson, New Brunswick, NJ USA

[12] BeiGene, Cambridge, MA USA

[13] Genentech Inc, South San Francisco, CA USA

[14] Yale Canc Ctr, Yale Sch Med, New Haven, CT USA

[15] Sci 37, Durham, NC USA

[16] Univ Texas Southwestern Med Ctr Dallas, Simmons Comprehens Canc Ctr, Internal Med, Gastrointestinal Oncol, Dallas, TX USA

[17] Jiangsu Hengrui Pharmaceut, Shanghai, Peoples R China

[18] Novartis, Basel, Switzerland

[19] AstraZeneca, Cambridge, England

[20] Bayer, Leverkusen, Germany

[21] Asia Soc, New York, NY USA

[22] Bloomberg LP, Bloomberg New Econ, New York, NY USA

[23] McKinsey & Co Inc, McKinsey Canc Ctr, New York, NY USA

[24] Guangdong Prov Peoples Hosp, Guangdong Lung Canc Inst, Guangdong Acad Med Sci, Chinese Thorac Oncol Grp, Guangzhou, Peoples R China

来源：

JAMA NETWORK OPEN | 2024年 / 7卷 / 04期

基金：

美国国家卫生研究院;

关键词：

CANCER; PARTICIPATION; HOSPITALS;

D O I：

10.1001/jamanetworkopen.2024.6228

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 MeasuresThe 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. ResultsAll 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 RelevanceThese 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.

引用

页数：8

共 22 条

[1] Association of Remote Technology Use and Other Decentralization Tools With Patient Likelihood to Enroll in Cancer Clinical Trials
Adams, Devon V.
Long, Sarah
Fleury, Mark E.
[J]. JAMA NETWORK OPEN, 2022, 5 (07) : E2220053
[2] [Anonymous], 2022, DIVERSITY PLANS IMPR
[3] [Anonymous], 2021, Five technical guidance principles, including the technical guidance principles for clinical evaluation of medical devices (No. 73 of 2021, State Administration for Market Regulation Decree No. 47)
[4] [Anonymous], 2021, Principle part 2, decision-making on the conduct of clinical trials for medical devices: technical guidance principles
[5] [Anonymous], BEST PRACTICES SURVE
[6] [Anonymous], 2023, Decentralized clinical trials for drugs, biological products, and devices: guidance for industry, investigators, and other stakeholders
[7] [Anonymous], 2016, Healthy China 2030" Plan Outline (Report No.2016-32)
[8] [Anonymous], 2021, Decision-making on the conduct of clinical trials for medical devices: technical guidance principles (draft resolution for public comments)
[9] [Anonymous], 2023, Healthy China action-cancer prevention and control action implementation plan (2023-2030) (National Health and Health Commission Urgent Notice [2023] No. 30)
[10] [Anonymous], 2022, Facilitating decentralised clinical trials in the EU

← 1 2 3 →