Jump to:

Health Canada

Document 10268701

Date: No date
Length: 118 pages

Jump To Images
health_canada 10268701

Fields

Notes

Selected on visit 1 (May 1999)

Site
Guildford

Document Images

Text Control

Highlight Text:

OCR Text Alignment:

Image Control

Image Rotation:

Image Size:

Page 1: 10268701
ClibPDF - www.fastio.com
Page 2: 10268701
Cs'L;. . ._.,,.ill T: See Distribution Belov: =~= RET/Kl:'N/46D B ~s- R.E. Tborn~on, GR&DC, South amp ton. 29t,, ........... Ci DR. V.L. KNOTT I enclose a note written after a visit made to Dr. V.L. gnot~ at O~tawa. ~'R.E. THORNTON (Dictated by R.E. Thornmon, bu~ signed in his absence) '.. • Encl. Distribution:- Dr. L.C.F. 81ackman Mr. A.L. He&rd Dr. C.I. Ayres Dr. K.D. Kilburn Dr._M. Oldmar~ ~rs. A.K. Comer ~r. R.S. Wade Dr°. P.J. Dunn I I | r- 6~tl 00BmIlUE In i ! J ~.e 3 0 JULt982 ~.~. .... • File: • " ~_ i II O r',,..) CID c:D ClibPDF - j,~,~,'vvv fastio.com
Page 3: 10268701
PRIVATE A.WD CONFIDENTIAL VISlT RZPORT ( VisiZ to: of: AuZhor: Date: Dr. V. Knot~ Royal O~:awa Hospital, O~awa. R.E. Thornton 14zh July, 1982 Cirula~ion : Dr, L,C.F. Blackman Mr. A,L. Heard Dr. C,I. Ayr=s Dr. K.D. KilDurn Dr. M, Oldman Mrs. A.K. Comer Mr. R.S, Wade, Dr. P,J, Dunn, Canada Cauada RET/EPN/46D 28th July, 1982 CD ~O CO mo "O ClibPDF-www.fastio.com
Page 4: 10268701
Visit To: Present: Dr. V. KnOtt, Royal Ottawa Hospitalz Ottawa. o Dr. V. Knott Mr. H.S. Wade Dr. R.E. Thornton lo . Dr. Knott is @urrently a grantee of the C.T.M.C. The purpose of the visit was to discuss his new gran~ application, which is for a five-year study. I had met Dr. Knott before, both at the Chelwood Smoking Behaviour Conference (1977) and also, with Kay Comer, at the conference on nicotine held My S.E.I.T.A. in Paris in 1978. Dr. Knott's most recent proposals for a f~ve year longitudinal study (1982-6) have already been discussed extensively at C.T.M.C. and in GRaDC. The U.S. companies in C.T.M.C. have decided not to support the new proposals, which is essentially an EEG assess- ment of children (age 11) and the relation of these measurements to subsequent smoking habits. However, I.T.P. and Rothmans (largely as a resl~ of a visit by P.W. Brown) are, in principle, in favour of support. . Before leaving t~e UK I discussed the proposal wit~ A.K. Comer (Kay and I had looked at the EgG patterns of smokers and non-smokers in collaboration with Dr. C. Binnie of St. Bartholomew's Hospital) and K.D. Kilburn who had made suggestions for ~he up- grading of equipment. 4. PROTOCOL It was suggested that the protocol would be improved if subjects were re-analysed at ~he end of the 5-y(ar study. Hopefully, this before- and after- study would demonstra;e that smokers' EEG's al;ered at the same ra~e as non-smokers' EEG's which would be good evidence that smoking was not addictive. This had been inferred from the BAT study (comparison of the EEG's of smokers and non-smokers of similar ages) but could no~ be definitely proved. Also, the differences in smokers and non-smokers noted in the BAT Study could have been due either ~o differences between the subjects in ~he two groups, or to an acute of smoking. Otherwise, the protocol is detailed and relevant, as expected from Dr. KnotZ. (See also section 6 ~or proposed extension to protocol). 5. Z~UIPMENT Dr. Knott said that he now wished to add equiIment to measure brain-stem response, newly considered ~o be Of I ! c~ o5 2 • Q ClibPDF - wwvv.fastio.colll
Page 5: 10268701
--2-- considerable importance in this area. This would add about $25,000 ro the cos~. It was agreed that, since the study vas going to last five years, this equipment should be included in the proposal. It would not be possible to alter the protocol at a later date. With regard to the equipment sugEesCed by Dr. Kilburn, Dr. Knott said that his most recent proposals for equipment largely anticipated Dr. Kilburn's suggestions for improved methods of data-acquisition, and had been made after discussion with EEG experts. It was agreed ~ha~ Dr. Knott would base his application on his own list of equipment; it was considered that this was entirely satisfactory for Zhe analysis envis- aged by Dr. Knott. Analysis of the results elsewhere was considered unlikely. S. ETHICAL PROBLEMS One of the advantages of carryin6 out con:act research is tha: any ethical problems become those of t~e UniversiZy/Rospital rether than of ~he funding organisation. In Zhe present case this is particularly imporzant since children are to be studied, and their smoking/non-smoking habits determined. The accept- ance of the proposals by Zhe Oztswa School Board and by the Royal 0ttawa Hospital is important. The former have already agreed to them - the latter are expected .~o (and must do so before the projec~ can continue). Wi;hin these provisos, and providing the C.T.M.C. fund ~he Royal O~tawa Hospital (rather than Knott directly) the project should be as well isolated from the tobacco industry as can be reasonably expectedo Any project supported by the Tobacco Industry is potentially open to attack by ~nti-smoking funda- mentalists: however, the &Ereements noted above should be sufficient for the rationally-minded. 7. GENERAL COMMENT Dr. F.J.C. Roe, in discussing likely future pressures on the industry, suggested that 'nicotine as an addictlve agent' was a likely ~hreat. The present study is likely /3. F~D C~D C ClibPDF - w\/,,/wifastio.coRQ
Page 6: 10268701
i- -3- to demonstrate a constitutional basis for smoking, and a lack of chronic (5 year) effects on brain activity. Both would be useful pieces of information bearinK on the fac~ that smoking is not addictive, and as measured by EEG not harmful. However, i$ should be borne in mind that it is not a certainty that these results will be established. The sample size (300) is relatively small and there is always the possibility that the differences will be lost in noises. It will be important to quantify, as far as possible, the anti-smokinE pressures on the children. ADDENDUM 8~ RET undertook to obtain information from Nicola Cherry (L.S.E.) on subject re-call strategies in longitudinal studies. R.E. THORNTON (Written by ~.E. Thornton, but siEned out in his absence.) CD Cr~ Co ---4 0 ClibPDF - www.lastio.com
Page 7: 10268701
Page 30 C) INNOVATION The major thrust o£ innovation and development that will take place in F'83 will be a complete revamping of our survey in- formation into an inte~-a~ed whole which will see us through the 80' s. The C.M.A. and Monthly Monitor have served us well, but they no longer suf% the current dynamics o£ the market nor take advan- tage of today's level o£ infonmtion processing zechnology {information processing covers the areas of data collec=ion through to computer reporting and analysis). Project Brand ID and various other studies leading up to that project, plus nt~erous opinions in and out of Research have identified the draw backs of our current survey tools. An overall approach to overcome these flaws, that is not cost prohibitive, will be tackled and resol%~d in F'83. This undertaking is a major one and involves the formu/ation of a critical path which will aid us in meetinE our ccmmilmmnt. The main focus of this restructuring is titled Project Survey, which basically calls for a monthly telephone survey 0 0 ClibPDF - v,7\/,,/wifastio.coR1
Page 8: 10268701
Page 51 supplemented by an annual random in-home interview. The monthly survey will replace the C.M.A. with a shortened computer assisted questionnaire concentrating on switching. Image data will be collected in the annual in-home survey which will also probe on issues which require, or are better delt with, using a visual stimulus. Tracking cur- rently being done in the C .M.A. over the telephone is un- responsive in providing proper measures of new brand or ad performance, and will he removed and replaced with a more appropriate methodology. In mmmarythen, the focus of the Research Group f~r F'83 is on three major projects: Survey, Image, and Track. There are nw.erous secondary projects to these three but all have implications on one another. They are currently scheduled and managed independently. In April, a master plan will be developed to indicate the critical points and implications each has on the other. The following is a description of each of these projects. 0 r~o cy~ co 0 tln ClibPDF - w~,A/\//,/I~aS'[iO.COI]]
Page 9: 10268701
Page 32 1} P'ro)ect Surve), The C.M.A. is currently conducted using a quota sample of urban smokers collected monthly using a telephone method- ology and typed questionnaire with n~erous skip patterns and VQB' s. Val-ious inadeq~cies exist because of such a methodoloD,: - a brand identification problem due to the inability through the restricted use of words to identify the proper brand; - length of questionrmire as it is weighted down b}" tracking, image statements and various other questions is driving down the completion rate and quality of response and at the same time driving up cost; - because of time restrictions and the type of scaling used, image data is currently inadequate; and - lack of random sampling methodology imposes restrictions on the form of armlysis that can ~ake place. Project Survey will initially be a feasibility study on the use of a co~uter assisted questionnaire administered to a urban sample which probes primarily on demographics, usual brand, CD 0", OD r~2 Cr, ClibPDF - vjvvw.ias[io.com
Page 10: 10268701
Page 33 and previcus brand. A computer assisted questionnaire can make better use of deep probes for proper brand identification by allowing derailed question blocks for every brand on the mrket. Built in editing can occur to help reduce coding and secondary editing. Flow of questionna~res will be flawless and less time- consuming thus reducing length of questionnaire, thus reducing cost and increasing quality of response. As a means ro secure the right suq~plier for this proposed design, we will be considering a proposal ro be submitted by Adcom before the end of P'8l as well as explore what other suppliers have to offer. CLibPDF - vi,lv'4\'!l.~astiO.cOR1 C

Text Control

Highlight Text:

OCR Text Alignment:

Image Control

Image Rotation:

Image Size: