Hypotheses and fundamental study design characteristics for evaluating potential reduced-risk tobacco products. Part I: Heuristic.
Regul Toxicol Pharmacol
; 57(1): 1-10, 2010 Jun.
Article
em En
| MEDLINE
| ID: mdl-20018224
ABSTRACT
The risk-reducing effect of a potential reduced-risk tobacco product (PRRP) can be investigated conceptually in a long-term, prospective study of disease risks among cigarette smokers who switch to a PRRP and in appropriate comparison groups. Our objective was to provide guidance for establishing the fundamental design characteristics of a study intended to (1) determine if switching to a PRRP reduces the risk of lung cancer (LC) compared with continued cigarette smoking, and (2) compare, using a non-inferiority approach, the reduction in LC risk among smokers who switched to a PRRP to the reduction in risk among smokers who quit smoking entirely. Using standard statistical methods applied to published data on LC incidence after smoking cessation, we show that the sample size and duration required for a study designed to evaluate the potential for LC risk reduction for an already marketed PRRP, compared with continued smoking, varies depending on the LC risk-reducing effectiveness of the PRRP, from a 5-year study with 8000-30,000 subjects to a 15-year study with <5000 to 10,000 subjects. To assess non-inferiority to quitting, the required sample size tends to be about 10 times greater, again depending on the effectiveness of the PRRP.
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Nicotiana
/
Fumar
/
Abandono do Hábito de Fumar
/
Neoplasias Pulmonares
/
Modelos Teóricos
Tipo de estudo:
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Female
/
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Estados Unidos