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Clinical trials methods for evaluation of potential reduced exposure products.

ABSTRACT: Potential reduced exposure products (PREPs) to tobacco toxicants may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Such an assessment involves determining the effects of these products on biomarkers of exposure and effect, which serve as proxies for harm, and assessing the potential for consumer uptake and abuse of the product. This article identifies critical methodologic issues associated with PREP assessments, reviews the methods that have been used to assess PREPs, and describes the strengths and limitations of these methods. Additionally, recommendations are provided for clinical trial PREP assessment methods and future research directions in this area based on this review and on the deliberations from a National Cancer Institute sponsored Clinical Trials PREP Methods Workshop.

SUBMITTER: Hatsukami DK

PROVIDER: S-EPMC2799338 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

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Clinical trials methods for evaluation of potential reduced exposure products.

Hatsukami Dorothy K DK Hanson Karen K Briggs Anna A Parascandola Mark M Genkinger Jeanine M JM O'Connor Richard R Shields Peter G PG

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 20091201 12

Potential reduced exposure products (PREPs) to tobacco toxicants may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Such an assessment involves determining the effects of these products on biomarkers of exposure and effect, which serve as proxies for harm, and assessing the potential for consumer u ...[more]

PMID: 19959672

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Project description:Most tobacco-focused clinical trials are based on locally conducted studies that face significant challenges to implementation and successful execution. These challenges include the need for large, diverse, yet still representative study samples. This often means a protracted, costly, and inefficient recruitment process. Multisite clinical trials can overcome some of these hurdles but incur their own unique challenges. With recent advances in mobile health and digital technologies, there is now a promising alternative: Remote Trials. These trials are led and coordinated by a local investigative team, but are based remotely, within a given community, state, or even nation. The remote approach affords many of the benefits of multisite trials (more efficient recruitment of larger study samples) without the same barriers (cost, multisite management, and regulatory hurdles). The Coronavirus Disease 2019 (COVID-19) global health pandemic has resulted in rapid requirements to shift ongoing clinical trials to remote delivery and assessment platforms, making methods for the conduct of remote trials even more timely. The purpose of the present review is to provide an overview of available methods for the conduct of remote tobacco-focused clinical trials as well as illustrative examples of how these methods have been implemented across recently completed and ongoing tobacco studies. We focus on key aspects of the clinical trial pipeline including remote: (1) study recruitment and screening, (2) informed consent, (3) assessment, (4) biomarker collection, and (5) medication adherence monitoring. Implications With recent advances in mobile health and digital technologies, remote trials now offer a promising alternative to traditional in-person clinical trials. Remote trials afford expedient recruitment of large, demographically representative study samples, without undo burden to a research team. The present review provides an overview of available methods for the conduct of remote tobacco-focused clinical trials across key aspects of the clinical trial pipeline.

Dataset Information

Clinical trials methods for evaluation of potential reduced exposure products.

Publications

Clinical trials methods for evaluation of potential reduced exposure products.

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