This page
relates to conflicts of interest (COIs) at the research stage, that is before a
product comes on the market. It
focuses on preclinical research and clinical trials. It looks at the
interface between researchers, universities, public funding sources and
private corporate sponsors; technology transfer is thus a central
theme. Special attention is paid here to the full and unbiased
publication of results. Several documents also pertain to research misconduct and
research fraud.
Forms of financial COIs contemplated
here may include: executive positions in pharmaceutical, biotech and start-up
firms, advisory board positions, consultancy positions, expert witness
positions, patent rights, equity holdings or options in a biomedical firm,
research grants, gifts of research materials, other non-medical gifts.
Information
about conflicts of interest once the drug is approved and placed on the market
is found on the Promotion
page. Conflicts of
interest arising in connection with the request for a marketing authorization are reviewed on the Drug
Approval page.
Regulation: Supplemental Standards of Ethical Conduct and Financial
Disclosure Requirements for Employees of the Department of Health and Human
Services (February 3, 2005)
Arch. Intern. Med., PA Rochon et al., A study of
manufacturer-supported trials of nonsteroidal anti-inflammatory
drugs in the treatment of arthritis, 154 p.157 (1994)
Bhaven N. Sampat et al., Changes in university patent quality after the
Bayh-Dole act: a re-examination, 21 International Journal of Industrial
Organization p.1371-1390 (2003)
Nancy Olivieri,
Apotex and the University of Toronto
Case T-326/99 - Judgment of the Court of First Instance of 18 December 2003 - Nancy Oliviery v. Commission and EMEA - opposition to marketing authorization