Taking Tele Behind the Scenes: Remote Clinical Trial Monitoring Comes of Age During the COVID-19 Pandemic

Williams, E. L.; Pierre, Desiree L; Martin, Mary Ellen; Beg, Muhammad Shaalan; Gerber, David E.

doi:10.1200/op.21.00524

Cited by 13 publications

(12 citation statements)

References 4 publications

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“…Consistent with moves toward more decentralized clinical trials [ 35 , 36 ], the pivot to remote monitoring due to COVID-19 was successful for this study and will be incorporated in future studies. Videoconferencing tools, electronic data capture, and electronic signatures allowed for more efficient and timely communication, expanded sponsor participation in on-site activities, and reduced travel-related costs and off-site supervision of participant interviews by monitoring staff.…”

Section: Discussionmentioning

confidence: 70%

Designing Studies to Inform Tobacco Harm Reduction: Learnings From an Oral Nicotine Pouch Actual Use Pilot Study

Campbell¹,

Feehan²,

Kanitscheider³

et al. 2022

JMIR Form Res

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Background Introduction of new tobacco products in the United States, including those that may be lower on the risk continuum than traditional combustible cigarettes, requires premarket authorization by the US Food and Drug Administration and information on the potential impact of the products on consumer behaviors. Efficient recruitment and data capture processes are needed to collect relevant information in a near-to-real-world environment. Objective The aim of this pilot study was to develop and test a protocol for an actual use study of a new tobacco product. The product included in this study was a commercially available oral nicotine pouch. Through the process of study design and execution, learnings were garnered to inform the design, execution, analysis, and report writing of future full-scale actual use studies with tobacco products. Methods A small sample (n=100) of healthy adult daily smokers of 7 or more cigarettes per day were recruited to participate in an 8-week prospective observational study conducted at 4 geographically dispersed sites in the United States. A smartphone-based customized electronic diary (eDiary) was employed to capture daily tobacco product use, including 1 week of baseline smoking and 6 weeks during which participants were provided with oral nicotine pouches for use as desired. Results Online screening procedures with follow-up telephone interviews and on-site enrollment were successfully implemented. Of 100 participants, 97 completed the study, with more than half (59/99, 60%) identifying as dual- or poly-users of cigarettes and other types of tobacco products at baseline. There was more than 90% (91-93/99, 92%-94%) compliance with daily eDiary reporting, and the majority (92/99, 93%) of participants expressed satisfaction with the study processes. Product use data from the eDiary indicated that after an initial period of trial use, pouches per day increased among those continuing to use the products, while per day average cigarette consumption decreased for 82% (79/97) of all study participants. At the end of the week 6, 16% (15/97) of participants had reduced their cigarette consumption by more than half. Conclusions The design of this study, including recruiting, enrollment, eDiary use, and oversight, was successfully implemented through the application of a detailed protocol, a user-friendly eDiary, electronically administered questionnaires, and remote monitoring procedures. High-resolution information was obtained on prospective changes in tobacco product use patterns in the context of availability of a new tobacco product. Future, larger actual use studies will provide important evidence supporting the role that alternatives to combustible cigarettes may play in smoking reduction and/or cessation and lowering the population health burden of tobacco and nicotine-containing products.

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Section: Discussionmentioning

confidence: 70%

Designing Studies to Inform Tobacco Harm Reduction: Learnings From an Oral Nicotine Pouch Actual Use Pilot Study

Campbell¹,

Feehan²,

Kanitscheider³

et al. 2022

JMIR Form Res

View full text Add to dashboard Cite

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“…Use of centralized remote data monitoring to supplement in-person visits is widespread [ 2 ], and prior research has examined specific risk-based monitoring and electronic data capture tools for this purpose [ [11] , [12] , [13] , [14] ]. During the COVID-19 pandemic, remote site initiation visits and monitoring became more common, with some investigators emphasizing the utility of these methods to decrease costs and increase efficiency even as pandemic restrictions ease [ [15] , [16] , [17] ]. Much of this literature describes trials with active pharmaceutical interventions, and some provide guidance for data quality monitoring by sponsors or contract research organizations [ 15 , 18 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

An approach to virtual clinical trial site visits: Lessons from the MeTeOR trial

McHugh

Gottreich

Kumara

et al. 2023

Osteoarthritis and Cartilage Open

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“…As such, this study provides insight in how remote studies can be performed in an efficient way and how they may benefit participants and the research as a whole (eg, remote visits allow more flexibility and can easily fit into the participant's daily schedules), thereby adding to limited evidence on remote or decentralised trials. 61 This study has some methodological challenges. First, due to the nature of the intervention, blinding of patients and participating practices is not possible, introducing the possibility of performance bias (ie, improved adherence behaviour due to knowledge on allocation).…”

Section: Discussionmentioning

confidence: 99%

“…Remote research methods, including video conference systems and postal delivery of questionnaires and devices, are innovative ways of performing research. As such, this study provides insight in how remote studies can be performed in an efficient way and how they may benefit participants and the research as a whole (eg, remote visits allow more flexibility and can easily fit into the participant’s daily schedules), thereby adding to limited evidence on remote or decentralised trials 61…”

Section: Discussionmentioning

confidence: 99%

Effectiveness, usability and acceptability of a smart inhaler programme in patients with asthma: protocol of the multicentre, pragmatic, open-label, cluster randomised controlled ACCEPTANCE trial

et al. 2022

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IntroductionSuboptimal asthma control is associated with incorrect inhaler use and poor medication adherence, which could lead to unfavourable clinical and economic outcomes. Smart inhaler programmes using electronic monitoring devices (EMDs) could support self-management and increase medication adherence and asthma control. However, evidence on long-term benefits and acceptability is scarce. This study aims to investigate the effectiveness of a smart inhaler asthma self-management programme on medication adherence and clinical outcomes in adults with uncontrolled asthma, to evaluate its acceptability and to identify subgroups who would benefit most based on patient characteristics.Methods and analysisThis open-label cluster randomised controlled trial of 12 months will be conducted in primary care in the Netherlands. General practices will be randomly assigned to either intervention or control group. We aim to include 242 patients. The intervention consists of (1) an EMD attached to the patient’s inhaler that measures medication use; (2) a smartphone application to set medication reminders, receive motivational messages and track asthma symptoms; and (3) a portal for healthcare professionals to view data on medication use. The control group is passively monitored by the EMD but cannot view their inhaler data or receive feedback. Eligible patients are adults with suboptimal controlled asthma (Asthma Control Questionnaire score ≥0.75) with evidence of non-adherence established by the EMD during a 6-week run-in period. Primary outcome is the difference in mean medication adherence between intervention and control group. Secondary outcomes include asthma control, asthma-related quality of life, exacerbations, acceptance, cost-effectiveness and whether the effect of the intervention on medication adherence and asthma control is modified by patient characteristics (eg, self-efficacy, medication beliefs and eHealth literacy).Trial registration numberNL7854.

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Taking Tele Behind the Scenes: Remote Clinical Trial Monitoring Comes of Age During the COVID-19 Pandemic

Cited by 13 publications

References 4 publications

Designing Studies to Inform Tobacco Harm Reduction: Learnings From an Oral Nicotine Pouch Actual Use Pilot Study

Designing Studies to Inform Tobacco Harm Reduction: Learnings From an Oral Nicotine Pouch Actual Use Pilot Study

An approach to virtual clinical trial site visits: Lessons from the MeTeOR trial

Effectiveness, usability and acceptability of a smart inhaler programme in patients with asthma: protocol of the multicentre, pragmatic, open-label, cluster randomised controlled ACCEPTANCE trial

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