Methods used in internal industry clinical trials to assess tobacco risk reduction.
OBJECTIVE
Methods to assess reduced exposure products should include those that aid in determining likely patterns of human use and exposure. Tobacco industry clinical trial methods may provide insight into strategies to assess potential reduced exposure products (PREP) for public health purposes. Internal tobacco industry documents detailing human clinical research with PREPs were examined to document major research strategies used and identify potentially fruitful methods not currently used in the mainstream arena.


METHODS
Primary data were obtained from records of research conducted internally by tobacco companies and affiliated researchers, and included manuscript drafts, presentations, protocols, and instruments relating to internal clinical trials of human tobacco use and exposure.


RESULTS
Tobacco industry clinical research has focused on reduced exposure products, most notably Premier, Accord, and Eclipse. The most widely used strategy observed is switching studies, and details of study designs and protocols favored by the industry are described. Key measures include biomarkers of exposure (e.g., cotinine, CO, and specific carcinogens) and acute health effects such as physical health and fitness.


CONCLUSIONS
Tobacco industry clinical research has used relatively standard switching study methods, but with a broad set of measures. Clinical switching studies have been conducted by the industry primarily to support existing claims or to develop new claims. Knowledge of prior industry activity can guide and inform future public health research efforts. Although industry clinical trial methods are comparable with current mainstream methods, limited information about the validity of outcome measures used limits their viability for immediate adoption in mainstream science.
Rees
Vaughan W
VW
Harvard School of Public Health, Boston, MA 02115, USA. vrees@hsph.harvard.edu
Kreslake
Jennifer M
JM
O'Connor
Richard J
RJ
Cummings
K Michael
KM
Parascandola
Mark
M
Hatsukami
Dorothy
D
Shields
Peter G
PG
Connolly
Gregory N
GN
D002986:Clinical Trials as Topic; D003257:Consumer Product Safety / Q000592:standards*; D006801:Humans; D040242:Risk Reduction Behavior; D012907:Smoking / Q000009:adverse effects*; D016540:Smoking Cessation / Q000379:methods*; D019460:Tobacco Industry; D014028:Tobacco Smoke Pollution / Q000517:prevention & control*
D014028:Tobacco Smoke Pollution