-
1
-
-
57749209609
-
-
CBC Television, March 18, January 19
-
CBC Television. Marketplace: Drug Trials. March 18, 2003. www.cbc.ca/consumers/market/files/health/drug_trials (January 19, 2008).
-
(2003)
Marketplace: Drug Trials
-
-
-
2
-
-
77955426876
-
The tribulations of community-based trials
-
Silversides, A. The tribulations of community-based trials. CMAJ 170:33, 2004.
-
(2004)
CMAJ
, vol.170
, pp. 33
-
-
Silversides, A.1
-
3
-
-
0004056367
-
-
Patented Medicine Prices Review Board, Ottawa
-
Patented Medicine Prices Review Board. Annual Report 2001. Ottawa, 2002.
-
(2002)
Annual Report 2001
-
-
-
4
-
-
5444221704
-
-
Patented Medicine Prices Review Board, Ottawa
-
Patented Medicine Prices Review Board. Annual Report 2003. Ottawa, 2004.
-
(2004)
Annual Report 2003
-
-
-
5
-
-
33750849196
-
-
Patented Medicine Prices Review Board, Ottawa
-
Patented Medicine Prices Review Board. Annual Report 2005. Ottawa, 2006.
-
(2006)
Annual Report 2005
-
-
-
6
-
-
57749170912
-
-
Health Products and Food Branch. Review of the 2001 Clinical Trials Regulatory Framework: Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects). Health Canada, Ottawa, 2007.
-
Health Products and Food Branch. Review of the 2001 Clinical Trials Regulatory Framework: Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects). Health Canada, Ottawa, 2007.
-
-
-
-
11
-
-
57749187051
-
Canada Commits to R&D
-
1-3-0-0-inp_intelligencve_art-0-144037,00.html January 19
-
Kermani, F., and Gittins, R. Canada Commits to R&D. 2004. www.inpharm.com/External/InpH/1,,1-3-0-0-inp_intelligencve_art-0-144037,00.html (January 19, 2008).
-
(2004)
-
-
Kermani, F.1
Gittins, R.2
-
12
-
-
57749186400
-
Regulations amending the Food and Drug Regulations (1024-clinical trials): Regulatory impact analysis statement
-
January 19
-
Government of Canada. Regulations amending the Food and Drug Regulations (1024-clinical trials): Regulatory impact analysis statement. Canada Gazette 134:227-260, 2000. http://canadagazette.gc.ca/partI/2000/20000122/ html/regle-e. html#i2 (January 19, 2008).
-
(2000)
Canada Gazette
, vol.134
, pp. 227-260
-
-
-
13
-
-
57749202656
-
Canada may speed access to its human guinea pigs: Ethicists queasy about plan to approve clinical trials in 48 hours
-
Toronto, October 25
-
Karleff, I. Canada may speed access to its human guinea pigs: Ethicists queasy about plan to approve clinical trials in 48 hours. Globe and Mail (Toronto), October 25, 1999.
-
(1999)
Globe and Mail
-
-
Karleff, I.1
-
14
-
-
57749203546
-
Regulations amending the Food and Drug Regulations (1024 - clinical trials)
-
Government of Canada
-
Government of Canada. Regulations amending the Food and Drug Regulations (1024 - clinical trials). Canada Gazette 135:1116-1153, 2001.
-
(2001)
Canada Gazette
, vol.135
, pp. 1116-1153
-
-
-
15
-
-
57749178359
-
-
Auditor General of Canada. Allocating funds to regulatory programs - Health Canada. In Report of the Auditor General of Canada to the House of Commons, chap. 8. Ottawa, 2006.
-
Auditor General of Canada. Allocating funds to regulatory programs - Health Canada. In Report of the Auditor General of Canada to the House of Commons, chap. 8. Ottawa, 2006.
-
-
-
-
16
-
-
57749195674
-
-
Therapeutic Products Programme. International Strategy. Ottawa, April 1999.
-
Therapeutic Products Programme. International Strategy. Ottawa, April 1999.
-
-
-
-
18
-
-
0034828153
-
Trading risks for markets: The international harmonisation of pharmaceuticals regulation
-
Abraham, J., and Reed, T. Trading risks for markets: The international harmonisation of pharmaceuticals regulation. Health Risk Society 3:113-128, 2001.
-
(2001)
Health Risk Society
, vol.3
, pp. 113-128
-
-
Abraham, J.1
Reed, T.2
-
19
-
-
57749169008
-
-
Standing Senate Committee on Social Affairs Science and Technology. The Health of Canadians - The Federal Role, 5: Principles and Recommendations for Reform - Part 1. The Senate, Ottawa, 2002.
-
Standing Senate Committee on Social Affairs Science and Technology. The Health of Canadians - The Federal Role, Vol. 5: Principles and Recommendations for Reform - Part 1. The Senate, Ottawa, 2002.
-
-
-
-
20
-
-
20344365457
-
-
Ottawa, January 19, 2008
-
Department of Justice. Food and Drug Regulations. Ottawa, 2006. http://laws.justice.gc.ca/enF-27/C.R.C.-c.870/text.html (January 19, 2008).
-
(2006)
Food and Drug Regulations
-
-
-
21
-
-
0642369198
-
The human subjects trade: Ethical and legal issues surrounding recruitment incentives
-
Lemmens, T., and Miller, P. B. The human subjects trade: Ethical and legal issues surrounding recruitment incentives. J. Law Med. Ethics 31:398-418, 2003.
-
(2003)
J. Law Med. Ethics
, vol.31
, pp. 398-418
-
-
Lemmens, T.1
Miller, P.B.2
-
22
-
-
57749204295
-
E-1: Ethics review for human subjects research - interviews with members of research ethics boards and national organizations
-
ed. M. McDonald. Law Commission of Canada
-
Beagan, B. L. Section E-1: Ethics review for human subjects research - interviews with members of research ethics boards and national organizations. In The Governance of Health Research Involving Human Subjects (HRIHS), ed. M. McDonald. Law Commission of Canada, 2000.
-
(2000)
The Governance of Health Research Involving Human Subjects (HRIHS)
-
-
Beagan, B.1
Section, L.2
-
23
-
-
57749196910
-
Doctors buying ethics approval
-
February 27
-
Munro, M. Doctors buying ethics approval. Vancouver Sun, February 27, 2004.
-
(2004)
Vancouver Sun
-
-
Munro, M.1
-
24
-
-
0034574157
-
Ethics review for sale? Conflict of interest and commercial research review boards
-
Lemmens, T., and Freedman, B. Ethics review for sale? Conflict of interest and commercial research review boards. Milbank Q. 78:547-584, 2000.
-
(2000)
Milbank Q
, vol.78
, pp. 547-584
-
-
Lemmens, T.1
Freedman, B.2
-
25
-
-
0003641378
-
-
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Interagency Secretariat on Research Ethics, Ottawa
-
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Interagency Secretariat on Research Ethics, Ottawa, 2005.
-
(2005)
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
-
-
-
26
-
-
57749181492
-
UBC broke federal ethics rules by failing to adequately warn patients
-
February 25
-
Munro, M. UBC broke federal ethics rules by failing to adequately warn patients. Vancouver Sun, February 25, 2004.
-
(2004)
Vancouver Sun
-
-
Munro, M.1
-
27
-
-
57749203093
-
Prozac research targets local girls
-
November 2
-
Walters, J. Prozac research targets local girls. Hamilton Spectator, November 2, 2001.
-
(2001)
Hamilton Spectator
-
-
Walters, J.1
-
28
-
-
57749208328
-
Critical patients not informed UBC trial could hasten death: U.S. health officials.
-
February 27
-
Munro, M. Critical patients not informed UBC trial could hasten death: U.S. health officials. Vancouver Sun, February 27, 2004.
-
(2004)
Vancouver Sun
-
-
Munro, M.1
-
29
-
-
57749198595
-
Doctors pressure human guinea pigs
-
February 23
-
Munro, M. Doctors pressure human guinea pigs. Vancouver Sun, February 23, 2004.
-
(2004)
Vancouver Sun
-
-
Munro, M.1
-
30
-
-
57749208116
-
Cozying up to drug firms disturbs some physicians
-
February 24
-
Cornacchia, C. Cozying up to drug firms disturbs some physicians. Montreal Gazette, February 24, 2004.
-
(2004)
Montreal Gazette
-
-
Cornacchia, C.1
-
31
-
-
57749171959
-
-
Walker, R. Why FP research works. Medical Post, August 10, 1999, p. 31.
-
Walker, R. Why FP research works. Medical Post, August 10, 1999, p. 31.
-
-
-
-
32
-
-
57749193676
-
Drug firms pay $3,000 or more per patient for trials
-
February 24
-
Munro, M. Drug firms pay $3,000 or more per patient for trials. Vancouver Sun, February 24, 2004.
-
(2004)
Vancouver Sun
-
-
Munro, M.1
-
34
-
-
0032422544
-
The evolution of clinical trials: Inclusion and representation
-
Rochon, P. A., Berger, P. B., and Gordon, M. The evolution of clinical trials: Inclusion and representation. CMAJ 159:1373-1374, 1998.
-
(1998)
CMAJ
, vol.159
, pp. 1373-1374
-
-
Rochon, P.A.1
Berger, P.B.2
Gordon, M.3
-
36
-
-
57749182145
-
-
Health Products and Food Branch. Guidance for Industry: Clinical Investigation of Medicinal Products in the Pediatric Population: ICH Topic E11. Health Canada, Ottawa, 2003.
-
Health Products and Food Branch. Guidance for Industry: Clinical Investigation of Medicinal Products in the Pediatric Population: ICH Topic E11. Health Canada, Ottawa, 2003.
-
-
-
-
37
-
-
57749184975
-
You failed to protect rights, safety and welfare of boy
-
February 26
-
Munro, M. "You failed to protect rights, safety and welfare" of boy. Vancouver Sun, February 26, 2004.
-
(2004)
Vancouver Sun
-
-
Munro, M.1
-
38
-
-
57749184288
-
-
Canadian Press. Health Canada Sets New Clinical Drug Trial Rules. October 16, 2006. www.ctv.ca/servlet/ArticleNews/print/CTVNews/20061016/ h_canada_tr_061016/20061016/?hub=Health&subhub=PrintStory (January 19, 2008).
-
Canadian Press. Health Canada Sets New Clinical Drug Trial Rules. October 16, 2006. www.ctv.ca/servlet/ArticleNews/print/CTVNews/20061016/ h_canada_tr_061016/20061016/?hub=Health&subhub=PrintStory (January 19, 2008).
-
-
-
-
39
-
-
57749193913
-
-
Health Canada. To Clinical Trial Sponsors: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials Involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties. Ottawa, July 23, 2006.
-
Health Canada. To Clinical Trial Sponsors: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials Involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties. Ottawa, July 23, 2006.
-
-
-
-
41
-
-
0028127412
-
Therapeutic-class wars - drug promotion in a competitive marketplace
-
Kessler, D. A., et al. Therapeutic-class wars - drug promotion in a competitive marketplace. N. Engl. J. Med. 331:1350-1353, 1994.
-
(1994)
N. Engl. J. Med
, vol.331
, pp. 1350-1353
-
-
Kessler, D.A.1
-
42
-
-
23944521327
-
The contract research organization and the commercialization of scientific research
-
Mirowski, P., and Van Horn, R. The contract research organization and the commercialization of scientific research. Soc. Stud. Sci. 35:503-548, 2005.
-
(2005)
Soc. Stud. Sci
, vol.35
, pp. 503-548
-
-
Mirowski, P.1
Van Horn, R.2
-
43
-
-
0032566360
-
Reporting of gender-related information in clinical trials of drug therapy for myocardial infarction
-
Rochon, P. A., et al. Reporting of gender-related information in clinical trials of drug therapy for myocardial infarction. CMAJ 159:321-327, 1998.
-
(1998)
CMAJ
, vol.159
, pp. 321-327
-
-
Rochon, P.A.1
-
44
-
-
19444387284
-
Academic medical centers' standards for clinical-trial agreements with industry
-
Mello, M. M., Clarridge, B. R., and Studdert, D. M. Academic medical centers' standards for clinical-trial agreements with industry. N. Engl. J. Med. 352:2202-2210, 2005.
-
(2005)
N. Engl. J. Med
, vol.352
, pp. 2202-2210
-
-
Mello, M.M.1
Clarridge, B.R.2
Studdert, D.M.3
-
45
-
-
0036169082
-
Early Toronto experience with new standards for industry-sponsored clinical research - a progress report
-
and Research Committee and Clinical Study Agreements Working Group of the Toronto Academic Health Science Council
-
Naylor, C. D., and Research Committee and Clinical Study Agreements Working Group of the Toronto Academic Health Science Council. Early Toronto experience with new standards for industry-sponsored clinical research - a progress report. CMAJ 166:453-456, 2002.
-
(2002)
CMAJ
, vol.166
, pp. 453-456
-
-
Naylor, C.D.1
-
46
-
-
9644278127
-
Transparency in drug regulation: Mirage or oasis?
-
Lexchin, J., and Mintzes, B. Transparency in drug regulation: Mirage or oasis? CMAJ 171:1363-1365, 2004.
-
(2004)
CMAJ
, vol.171
, pp. 1363-1365
-
-
Lexchin, J.1
Mintzes, B.2
-
47
-
-
57749171336
-
-
Health Canada. Issue Analysis Summary: Summary Basis of Decision - Draft 7. Ottawa, 2004.
-
Health Canada. Issue Analysis Summary: Summary Basis of Decision - Draft 7. Ottawa, 2004.
-
-
-
-
48
-
-
1942445850
-
Drug company experts advised staff to withhold data about SSRI use in children
-
Kondro, W., and Sibbald, B. Drug company experts advised staff to withhold data about SSRI use in children. CMAJ 170:783, 2004.
-
(2004)
CMAJ
, vol.170
, pp. 783
-
-
Kondro, W.1
Sibbald, B.2
-
49
-
-
9644253392
-
Warning signs: E-mails suggest Merck knew Vioxx's dangers at early stage as heart-risk evidence rose, officials played hardball; internal message: "dodge!"
-
November 1
-
Mathews, A. W., and Martinez, B. Warning signs: e-mails suggest Merck knew Vioxx's dangers at early stage as heart-risk evidence rose, officials played hardball; internal message: "dodge!" Wall Street Journal, November 1, 2004.
-
(2004)
Wall Street Journal
-
-
Mathews, A.W.1
Martinez, B.2
-
50
-
-
57749202426
-
-
Meier, B. Merck backs U.S. database to track drug trials. New York Times, June 18, 2004.
-
Meier, B. Merck backs U.S. database to track drug trials. New York Times, June 18, 2004.
-
-
-
-
51
-
-
29544449337
-
Trial registration at clinicaltrials.gov between May and October 2005
-
Zarin, D. A., Tse, T., and Ide, N. C. Trial registration at clinicaltrials.gov between May and October 2005. N. Engl. J. Med. 353:2779-2787, 2005.
-
(2005)
N. Engl. J. Med
, vol.353
, pp. 2779-2787
-
-
Zarin, D.A.1
Tse, T.2
Ide, N.C.3
-
55
-
-
33845622895
-
Relationship between pharmaceutical company user fees and drug approvals in Canada and Australia: A hypothesis-generating study
-
Lexchin, J. Relationship between pharmaceutical company user fees and drug approvals in Canada and Australia: A hypothesis-generating study. Ann. Pharmacotherapy 40:2216-2222, 2006.
-
(2006)
Ann. Pharmacotherapy
, vol.40
, pp. 2216-2222
-
-
Lexchin, J.1
-
57
-
-
57749209818
-
Health Canada, Ottawa, undated
-
Therapeutic Products Directorate
-
Therapeutic Products Directorate. Business Transformation Progress Report. Health Canada, Ottawa, undated.
-
Business Transformation Progress Report
-
-
-
59
-
-
28944440034
-
Smart regulation: Will the government's strategy work?
-
Graham, J. Smart regulation: Will the government's strategy work? CMAJ 173:1469-1470, 2005.
-
(2005)
CMAJ
, vol.173
, pp. 1469-1470
-
-
Graham, J.1
-
60
-
-
57749190975
-
-
External Advisory Committee on Smart Regulation, January 19, 2008
-
External Advisory Committee on Smart Regulation. Risk Management. Undated. http://epe.lac-bac.gc.ca/100/206/301/pco-bcp/committees/ smart_regulation-ef/2006-10-11/www.pco-bcp.gc.ca/smartreg-regint/en/index.html (January 19, 2008).
-
Risk Management. Undated
-
-
-
61
-
-
57749195675
-
-
Health Canada. Health Protection Legislative Renewal: Detailed Legislative Proposal. Ottawa, 2003.
-
Health Canada. Health Protection Legislative Renewal: Detailed Legislative Proposal. Ottawa, 2003.
-
-
-
-
62
-
-
57749188403
-
-
John Wiley and Sons, Hoboken, NJ
-
Hawthorne, F. Inside the FDA. John Wiley and Sons, Hoboken, NJ, 2005
-
(2005)
Inside the FDA
-
-
Hawthorne, F.1
|