Remote Methods for Conducting Tobacco-Focused Clinical Trials

Area of Science:

• Clinical Research Methodology
• Digital Health Technologies
• Tobacco Cessation Interventions

Background:

• Traditional tobacco-focused clinical trials face significant challenges in recruiting large, diverse samples, leading to protracted and costly processes.
• Multisite trials offer solutions but introduce their own management and regulatory complexities.
• The COVID-19 pandemic accelerated the need for remote clinical trial methodologies.

Purpose of the Study:

• To provide an overview of methods for conducting remote tobacco-focused clinical trials.
• To illustrate the implementation of these methods in ongoing and completed tobacco studies.
• To highlight the benefits of remote trials in addressing traditional trial limitations.

Main Methods:

• Review of available methods for remote clinical trial conduct.
• Focus on key trial pipeline aspects: recruitment, informed consent, assessment, biomarker collection, and adherence monitoring.
• Inclusion of illustrative examples from recent tobacco studies.

Main Results:

• Remote trials, enabled by mobile health and digital technologies, present a viable alternative to in-person studies.
• This approach facilitates efficient recruitment of large, demographically representative study samples.
• Remote methods streamline trial processes without overburdening research teams.

Conclusions:

• Remote clinical trials are a promising strategy for tobacco cessation research.
• Digital technologies enhance the efficiency and reach of tobacco studies.
• The remote approach overcomes many barriers associated with traditional and multisite trials.