Methods used in internal industry clinical trials to assess tobacco risk reduction

Cancer Epidemiology Biomarkers and Prevention

Volumn 18, Issue 12, 2009, Pages 3196-3208

  Rees, Vaughan W ^a   Kreslake, Jennifer M ^a   O'Connor, Richard J ^b   Cummings, K Michael ^b   Parascandola, Mark ^c   Hatsukami, Dorothy ^d   Shields, Peter G ^e   Connolly, Gregory N ^a  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c NATIONAL CANCER INSTITUTE   (United States)

^d UNIVERSITY OF MINNESOTA   (United States)

^e GEORGETOWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBON MONOXIDE; CARCINOGEN; CIGARETTE SMOKE CONDENSATE; COTININE;

CIGARETTE SMOKING; CLINICAL RESEARCH; CONTROLLED STUDY; EXERCISE; FILTER; FITNESS; HUMAN; OUTCOME ASSESSMENT; POTENTIAL REDUCED EXPOSURE PRODUCT; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; RISK REDUCTION; SAMPLE SIZE; TOBACCO; TOBACCO INDUSTRY;

CLINICAL TRIALS AS TOPIC; CONSUMER PRODUCT SAFETY; HUMANS; RISK REDUCTION BEHAVIOR; SMOKING; SMOKING CESSATION; TOBACCO INDUSTRY; TOBACCO SMOKE POLLUTION;

EID: 73349105578     PISSN: 10559965     EISSN: None     Source Type: Journal    
DOI: 10.1158/1055-9965.EPI-09-0819     Document Type: Review

References (49)

1. Stratton K, Shetty P, Wallace R, Bondurant S. Clearing the smoke: assessing the science base for tobacco harm reduction.Washington (DC): National Academy Press; 2001.
2. Hatsukami D. Methods to assess potential reduced exposure products. Nicotine Tob Res 2005;7:827-44.
3. Wayne G. Potential reduced exposure products (PREPs) in industry trial testimony. Tob Control 2006;15:iv90-7.
4. Carpenter C, Wayne G, Connolly G. The role of sensory perception in the development and targeting of tobacco products. Addiction 2007; 102:136-47.
5. Balbach E, Barbeau E. Beyond quagmires: The evolving quality of documents research. Am J Public Health 2005;14:361-2. 6. Carter S. Tobacco document research reporting. Tob Control 2005;14: 368-76.
6. Morris P. Total exposure study. 2005, Bates no. 3006463287/3006463312.
7. Morris P. Dose response investigation of carboxy-hemoglobin of adult smokers smoking conventional and electrically heated cigarettes. 2002, Bates no. 2505924579/2505924598.
8. Institutional Review Board, MDS Pharma Services, Philip Morris USA. In: Morris P, editor. A single-center study to evaluate the short term exposure to smoke constituents of electrically heated cigarettes in adult smokers during controlled smoking. 2001, Bates no. 2082036417/2082036461.
9. Stiles MF, Guy TD, Edwards DW, Morgan WT, Robinson JH. In: Reynolds RJ, editor. Human smoking behavior study: comparison of two Eclipse cigarette to usual brands. 1997, Bates no. 528480365/528480383.
10. Pence DH. In: Reynolds RJ, editor. Smoking behavior/blood study investigating current market product eclipse modification on blood carboxyhemoglobin and nicotine concentrations. 2004, Bates no. 551288734/551288736.
11. Reynolds RJ. Effect of the Eclipse registered trademark cigarette on symptoms in chronic bronchitis. 1999, Bates no. 521817643/521817654.
12. Morris P. Draft no. 5 research protocol: a randomized, controlled, crossover study comparing exercise capacity in healthy adult male smokers smoking electrically heated cigarettes, conventional cigarettes, and no-smoking. 2002, Bates no. 2067327075/2067327092.
13. Morris P. Speech/Presentation. 2001, Bates no. 2082668906/2082668909.
14. McKarns S, Byrd G, MorganW, et al. In: Reynolds RJ, editor. Correlation of human smoking behavior, the absorption and metabolism of nicotine, and the absorption of mutagens: a comparison between Eclipse and tobacco burning cigarettes. 1997, Bates no. 520008552/520008586.
15. Morris P. Assessment of human exposure. 2003, Bates no. 3006669940/3006669974.
16. Philip Morris. (no title). 2001. Bates no. 2082668906/2082668909.
17. Reynolds RJ. Human smoking behavior studies of cigarettes that primarily heat tobacco. 1996, Bates no. 515210846/515210897.
18. Reynolds RJ. Chemical and biological studies new cigarette prototypes that heat instead of burn tobacco. 1988, Bates no. 517559438/ 517559982.
19. Reynolds RJ. Feasibility of evaluation of the effect of switching to eclipse or snus on health related quality of life. 2006, Bates no. 552771906/552771947.
20. Rees VW, Kreslake JK, Cummings KM, et al. Assessing consumer responses to Potential reduced-exposure tobacco products: A review of tobacco industry and independent research methods. Cancer Epidemiol Biomarkers Prev 2009;18:3225-40.
21. Morris P. The analysis of smoking parameters: inhalation and absorption of tobacco smoke in studies of human smoking behavior. 1980, Bates no. 1003061294/1300.
22. Reynolds RJ. Data from several recent studies using tobacco heating cigarettes indicate that, in some smokers, blood levels of carboxyhemoglobin are increased over levels seen in smokers of tobacco burning cigarettes. 1995, Bates no. 516879121.
23. Nelson PR, Kelly SP, Conrad FW, Maiolo KC, Richardson JD, Mosberg AT. In: Reynolds RJ, editor. TOX-TES1999 001. Comparison of Eclipse prototype 8-163C to Marlboro 85 box, Marlboro Lights 85 box, Marlboro Lights 100S box, and Merit Ultra Lights 85 soft pack cigarettes: determination of environmental tobacco smoke component reductions. 1999, Bates no. 531101259/531101265.
24. Reynolds RJ. ETS testing program (claims substantiation). 1998, Bates no. 519257059/519257062.
25. Reynolds RJ. Attachment 1. Revised ETS testing program (claims substantiation/ product characterization). 1995, Bates no. 511222268/511222270.
26. Reynolds RJ. 1989 (890000) objectives. 1989, Bates no. 506995206/ 506995214.
27. Gordin HH. In: Reynolds RJ, editor. GTC claims substantiation testing. 1995, Bates no. 514284279/514284285. 29. Morris P.Clinical study learnings. 2003, Bates no. 3000166500/3000166515.
28. Tricker AR. In: Reynolds RJ, editor. Application of exposure biomarkers in clinical studies of potential reduced-exposure products. 2004, Bates no. 532879769/532879803.
29. Morris P. Scientific data summary: the electrically heated cigarette smoking system. 2003, Bates no. 3006673891/3006673997.
30. Reynolds RJ. Slide 1 title - human smoking behavior studies. 1995, Bates no. 516879111/516879120.
31. Kisicki JC. In: Morris P, editor. Investigator's brochure. A single-center study to evaluate the short term exposure to smoke constituents of an electrically heated cigarette smoking system in adult smokers during controlled smoking. 2001, Bates no. 2505914622/2505914639.
32. Reynolds RJ. Effect of the Eclipse registered trademark cigarette on lower respiratory tract inflammation in chronic bronchitis. 1999, Bates no. 521817627/521817642.
33. Roethig HJ, Zedler BK, Kinser RD, Feng S, Nelson BL, Liang Q. Short-term clinical exposure evaluation of a second-generation electrically heated cigarette smoking system. J Clin Pharmacol 2007;47: 518-30.
34. Wagner BM. In: Reynolds RJ, editor. Summary from scientific advisory board meeting held in San Antonio Texas, January 9-11, 2006 (20060109-20060111). 2006, Bates no. 2006:534203775/534203778.
35. Philip Morris. (no title). 2000 May. Bates no. 2073346376/2073346381.
36. Byrd G, Robinson J, Caldwell W, Debethizy J. Comparison of measured and FTC-predicted nicotine uptake in smokers. Psychopharmacology 1995;122:95-103.
37. Byrd G, Davis R, CaldwellW, Robinson J, Debethizy J. A further study of FTC yield and nicotine absorption in smokers. Psychopharmacology 1998;139:291-9.
38. Benowitz N. Biomarkers of environmental tobacco smoke exposure. Environ Health Perspect 1999;107:349-55.
39. Carchman RA, Haussmann H, Kinser RD, et al. In: Morris P, editor. Selection of biomarkers of exposure for a large population mainstream smoke exposure assessment. 2001, Bates no. 2084577173.
40. Gregg E, Williamson J, Proctor C, O'Reilly D. A proposed framework for PREP assessment. 2008.
41. Thompson A, Huerta G, Robbins R, et al. The bronchitis index. A semiquantitative visual scale for the assessment of airways inflammation. Chest 1993;103:1482-8.
42. Jones P, Quirk F, Baveystock C. The St. George's respiratory questionnaire. Respir Med 1991;85:25-31, discussion 33-27.
43. Roethig H. In: Morris P, editor. FW: 26586-Philip Morris IRB approved documents. 2001, Bates no. 2082051740A.
44. McDaniel P, Solomon G, Malone R. The ethics of industry experimentation using employees: the case of taste-testing pesticide-treated tobacco. Am J Public Health 2006;96:37-46.
45. White J, Parascandola M, Bero L. Tobacco industry research and protection of human subjects: a case study of R.J. Reynolds. Nicotine Tob Res 2007;9:1213-25.
46. Hatsukami DK, Hanson K, Briggs A, Parascandola M, Gerkinger J, Shields PG. Clinical trials methods for evaluation of potential reduced exposure products. Cancer Epidemiol Biomarkers Prev 2009; 18:3143-95.
47. Morris P. RD&E smoking & health update to corporate and legal senior management - 20010319. 2001, Bates no. 2505614607/2505614666.
48. Pence DH. In: Reynolds RJ, editor. Smoking behavior/blood study investigating current market product Eclipse modification on blood carboxyhemoglobin and nicotine concentrations. 2004, Bates no. 551288734/551288736.
49. Morris P. Selected attachments for: A 12-week randomized controlled study to evaluate exposure to smoke constituents of the electrically heated cigarette smoking system (EHCSS K 6) to Marlboro Ultra Lights in adult smokers during unrestricted smoking. Philip Morris Study no. Series EHCK6/02/03 MDS Pharma Services project no. AA03468 MDS Pharma Services Protocol no. 466-08. 2003, Bates no. 3006704047/3006704063.