Improving efficiency of initial tests for efficacy in smoking cessation drug discovery
Open accessAbstract
INTRODUCTION: One obstacle to rapid development of new smoking cessation medications is the inefficient early clinical evaluation of the efficacy of novel drugs, which inform us as to whether or not to proceed with the greater expense and time of more formal clinical trials. The vast majority of novel drugs fail to show efficacy for cessation only after substantial resources have been spent and, thus, are largely wasted. AREAS COVERED: The author reviews the general limitations in the current typical procedures for initial tests of cessation efficacy in novel drugs. Small, randomized clinical trials often have good validity but may have practical limitations in achieving adequate statistical power to test novel versus placebo treatment conditions. Lab tests of acute drug effects on abstinence symptoms, during brief enforced cessation periods, are practical but have limited clinical predictive validity. EXPERT OPINION: Initial efficacy testing may be more efficient if done using innovative crossover designs that evaluate brief 'practice' quit periods for both active and placebo treatments within the same smokers, recruiting those high in quit motivation. Because this approach would require far fewer subjects and a shorter duration of testing, results could be obtained more rapidly and inexpensively to indicate that a novel drug may, or may not, be sufficiently efficacious as to warrant the greater costs and time of formal randomized clinical trials.
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Because early abstinence success predicts continued abstinence, Titrators who remained engaged in the exercise intervention through quit week may have benefited comparably to Completers despite lower overall attendance.
“Since success with abstinence within the first 24 hours after quit is predictive of continued abstinence (Perkins, 2014), Titrators who were likely to remain engaged in the exercise intervention through quit week may have benefited comparably to Completers despite lower overall attendance.”
From Identifying attendance patterns in a smoking cessation treatment and their relationships with quit success (2017) · cites this paper as Perkins, 2014
Section 3.1 (page not specified) reports that the number of quit days in the first week predicts later quit status and proposes at least 24 hours of abstinence as a likely surrogate measure of drug efficacy. It does not specifically establish that abstinence within the first 24 hours predicts continued abstinence. The exercise-intervention comparison is the citing authors’ inference, not a claim attributed to Perkins. (LLM, conf=0.82)
Experimental — accuracy not yet measuredEarly abstinence success within the first 24 hours after quit predicts continued abstinence.
“Since success with abstinence within the first 24 hours after quit is predictive of continued abstinence (Perkins, 2014)”
From Identifying attendance patterns in a smoking cessation treatment and their relationships with quit success (2017) · cites this paper as Perkins, 2014
Section 3.1 (page not provided) proposes complete abstinence for at least 24 hours as a likely surrogate measure and reports that quit days during the first week predict later quit status. It does not establish that success specifically within the first 24 hours predicts continued abstinence. (LLM, conf=0.84)
Experimental — accuracy not yet measured
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Jacquart, J., Papini, S., Davis, M. L., Rosenfield, D., Powers, M. B., Frierson, G. M., Hopkins, L. B., Baird, S. O., Marcus, B. H., Church, T. S., et al. (2017) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2017.01.007 · Cited by 8 · see citing works
“Since success with abstinence within the first 24 hours after quit is predictive of continued abstinence (Perkins, 2014), Titrators who were likely to remain engaged in the exercise intervention through quit week may have benefited comparably to Completers despite lower overall attendance.”
Background
- Authors
- Perkins, K. A.
- Affiliations
- University of Pittsburgh (US)
- Corresponding author
- Perkins, Kenneth A
- ORCID
- Perkins, Kenneth A
- Venue
- Expert Opinion on Drug Discovery
- Publisher
- Informa UK Limited
- Published
- 2014-08-20
- Volume
- 9
- Issue
- 11
- Pages
- 1259-1264
- ISSN
- 1746-0441 (ISSN-L)
- 1746-045X
- OpenAlex
- W1985036681
- Semantic Scholar
- cc5ed6d9e9f43953824530adf05027ed07852855
- Cited by
- 11
- References
- 25
- Citations by year
- 2023: 1 · 2020: 1 · 2019: 1 · 2018: 1 · 2017: 4 · 2016: 1 · 2015: 1 · 2014: 1
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Expert Opinion on Drug Discovery (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (UH3TR000958)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
- Keywords
- smoking cessation, smoking cessation drugs, drug discovery, crossover design, abstinence symptoms, statistical power, randomized controlled trials
- MeSH terms
- Animals, Humans, Smoking, Smoking Cessation, Treatment Outcome, Drug Discovery
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