Skip to main content

Main menu

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 articles
    • Obituary notices
  • Authors & Reviewers
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
    • Patient engagement
  • Physicians & Subscribers
    • Benefits for Canadian physicians
    • CPD Credits for CMA Members
    • Subscribe to CMAJ Print
    • Subscription prices
    • Obituary notices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2023
    • Avis de décès
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN

User menu

Search

  • Advanced search
CMAJ
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN
CMAJ

Advanced Search

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 articles
    • Obituary notices
  • Authors & Reviewers
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
    • Patient engagement
  • Physicians & Subscribers
    • Benefits for Canadian physicians
    • CPD Credits for CMA Members
    • Subscribe to CMAJ Print
    • Subscription prices
    • Obituary notices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2023
    • Avis de décès
  • Visit CMAJ on Facebook
  • Follow CMAJ on Twitter
  • Follow CMAJ on Pinterest
  • Follow CMAJ on Youtube
  • Follow CMAJ on Instagram
Letters

Ethics and industry-sponsored research

Joseph L. Pater, Wendy Parulekar, Christopher O'Callagham, Lois Shepherd, Elizabeth Eisenhauer, Lesley Seymour, Dongsheng Tu and Keyue Ding
CMAJ March 05, 2002 166 (5) 581-582;
Joseph L. Pater
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ont.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Wendy Parulekar
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ont.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Christopher O'Callagham
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ont.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lois Shepherd
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ont.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Elizabeth Eisenhauer
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ont.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lesley Seymour
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ont.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Dongsheng Tu
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ont.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Keyue Ding
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ont.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Responses
  • Metrics
  • PDF
Loading

Although we agree with the publication rules suggested by Frank Davidoff and his colleagues in the International Committee of Medical Journal Editors,1 we think the implementation of the proposals of Steven Lewis and coauthors2 would seriously impair the conduct in Canada of academically credible clinical research carried out in partnership with industry. The examples cited by Lewis and colleagues are all warnings to investigators that companies are primarily responsible to their stockholders, but only one, the Olivieri case, relates to a dispute over the publication of results.2

Our experience in coordinating over 120 national clinical trials in which pharmaceutical companies supplied drugs or financial support or both suggests strongly that such untenable situations can be avoided if the principles identified by Davidoff and colleagues are contractually protected. In all of our trials we, or a partner academic group, create and maintain the trial database, analyze the trial data according to protocol-specified plans and have the right to publish our conclusions. Our host university insists on preserving these academic rights. Furthermore, we are ultimately accountable for all of our studies, whether supported by industry or by competitive grants, to the National Cancer Institute of Canada, which periodically peer reviews the scientific quality of our program and the trials we conduct.

By focusing on a few justly disturbing cases and not examining alternative models, Lewis and colleagues failed to gather the data needed to make sound recommendations.2 At a time when the major source of new therapeutic agents is the pharmaceutical industry, we need solutions that protect academic integrity but simultaneously allow Canadian trials to be developed and conducted quickly by qualified physician-investigators. The highly centralized and potentially bureaucratic system proposed by Lewis and colleagues might fulfill the former requirement but will certainly not fulfill the latter.

We feel strongly that better approaches must be adopted if Canadian investigators are to be adequately protected in, but not excluded from, an important research endeavour. Our experience suggests that the key elements of such approaches should include accountability to an agency that represents the public interest and a clear understanding on the part of investigators and university contract officers of their rights and responsibilities. All of this can be achieved by educational initiatives and appropriate leadership from existing professional and funding bodies.

References

  1. 1.↵
    Davidoff F, DeAngelis CD, Drazen JM, Nicholls MG, Hoey J, Højgaard L, et al. Sponsorship, authorship and accountability [editorial]. CMAJ 2001; 165(6):786-8.
    OpenUrlFREE Full Text
  2. 2.↵
    Lewis S, Baird P, Evans RG, Ghali WA, Wright CJ, Gibson E, et al. Dancing with the porcupine: rules for governing the university–industry relationship [editorial]. CMAJ 2001;165(6):783-5.
    OpenUrlFREE Full Text
PreviousNext
Back to top

In this issue

CMAJ
Vol. 166, Issue 5
5 Mar 2002
  • Table of Contents
  • Index by author

Article tools

Respond to this article
Print
Download PDF
Article Alerts
To sign up for email alerts or to access your current email alerts, enter your email address below:
Email Article

Thank you for your interest in spreading the word on CMAJ.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Ethics and industry-sponsored research
(Your Name) has sent you a message from CMAJ
(Your Name) thought you would like to see the CMAJ web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Ethics and industry-sponsored research
Joseph L. Pater, Wendy Parulekar, Christopher O'Callagham, Lois Shepherd, Elizabeth Eisenhauer, Lesley Seymour, Dongsheng Tu, Keyue Ding
CMAJ Mar 2002, 166 (5) 581-582;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
‍ Request Permissions
Share
Ethics and industry-sponsored research
Joseph L. Pater, Wendy Parulekar, Christopher O'Callagham, Lois Shepherd, Elizabeth Eisenhauer, Lesley Seymour, Dongsheng Tu, Keyue Ding
CMAJ Mar 2002, 166 (5) 581-582;
Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like

Jump to section

  • Article
    • References
  • Responses
  • Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Hospital-at-home programs in Canada: challenges and pitfalls
  • Author response to “Pitfalls of analyzing perinatal outcomes by health care provider”
  • Pitfalls of analyzing perinatal outcomes by health care provider
Show more Letters

Similar Articles

Collections

  • Topics
    • Journalology & publication ethics

 

View Latest Classified Ads

Content

  • Current issue
  • Past issues
  • Collections
  • Sections
  • Blog
  • Podcasts
  • Alerts
  • RSS
  • Early releases

Information for

  • Advertisers
  • Authors
  • Reviewers
  • CMA Members
  • CPD credits
  • Media
  • Reprint requests
  • Subscribers

About

  • General Information
  • Journal staff
  • Editorial Board
  • Advisory Panels
  • Governance Council
  • Journal Oversight
  • Careers
  • Contact
  • Copyright and Permissions
CMAJ Group

Copyright 2023, CMA Impact Inc. or its licensors. All rights reserved. ISSN 1488-2329 (e) 0820-3946 (p)

All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association or its subsidiaries.

To receive any of these resources in an accessible format, please contact us at CMAJ Group, 500-1410 Blair Towers Place, Ottawa ON, K1J 9B9; p: 1-888-855-2555; e: cmajgroup@cmaj.ca

CMA Civility, Accessibility, Privacy

 

Powered by HighWire