Stopping trials early for commercial reasons: The risk-benefit relationship as a moral compass

Journal of Medical Ethics

Volumn 31, Issue 7, 2005, Pages 410-414

  Iltis, A S ^a  

^a SAINT LOUIS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL STUDY; COMMERCIAL PHENOMENA; FINANCIAL MANAGEMENT; HUMAN; MEDICAL DECISION MAKING; MEDICAL ETHICS; MEDICAL INFORMATION; MEDICAL LITERATURE; MORALITY; RISK BENEFIT ANALYSIS; SAFETY; WELLBEING;

ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH;

CLINICAL TRIALS; COMMERCE; HUMAN EXPERIMENTATION; HUMANS; MORAL OBLIGATIONS; PATIENT PARTICIPATION; RISK ASSESSMENT; SOCIAL RESPONSIBILITY; SOCIAL VALUES;

EID: 21744447886     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2004.008771     Document Type: Article

References (19)

1. Lièvre M, Menard J, Bruckert E, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ 2001;322:603-5.
2. Viberti GC, Slama G, Pozza G, et al. Early closure of European Pimagedine trial. Lancet 1997; 350:214-5.
3. Black HR, Elliot WJ, Grandits G, et al. Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) Trial. JAMA 2003;289:2073-82.
4. Hopf G. Early stopping of trials. Lancet 1997; 350:891.
5. Langer A. Early stopping of trials [letter]. Lancet 1997;350:890-1.
6. Psaty BM, Rennie D. Stopping medical research to save money. JAMA 2003;289:2128-31.
7. Ashcroft R. Responsibilities of sponsors are limited in premature discontinuation of trials. BMJ 2001;323:53.
8. Boyd K. Early discontinuation violates Helsinki principles [commentary]. BMJ 2001;322:603.
9. Evans S, Pocock S. Societal responsibilities of clinical trial sponsors. BMJ 2001;322:569-70.
10. Anonymous. A curious stopping rule from Hoechst Marion Roussel [editorial]. Lancet 1997;350:155.
11. Brody B. The ethics of biomedical research. New York: Oxford University Press, 1998:156.
12. Pochin E. Risk and medical ethics. J Med Ethics 1982;8:180-4.
13. Herxheimer A. Benefit, risk and harm. Australian Prescriber 2001;24(1):18.
14. World Medical Association General Assembly. Declaration of Helsinki: Ethical medical principles for medical research involving human subjects. JAMA 2000;284:3043-5.
15. United States Federal Government. 45CFR46: Code of federal regulations. 2001. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm (accessed 30 November, 2004).
16. United States Federal Government. 21CFR50: Protection of human subjects. 1998. http://www.fda.gov/oc/ohrt/irbs/appendixb.html (accessed 11 March, 2004).
17. United States Federal Government. 21CFR56: Institutional review boards. 1998. http://www.fda.gov/oc/ohrt/irbs/appendixc.html (accessed 11 March, 2004).
18. Australian National Health and Medical Research Council. National statement on ethical conduct in research involving humans. 1992. http://www.nhmrc.gov.au/publications/humans/contents.htm (accessed 11 March, 2004).
19. Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine; 1997 Apr 4; Oviedo, Spain. Oviedo: Council of Europe, 1997, chapter 5, article 16. http://conventions.coe.int/treaty/en/treaties/html/164.htm (accessed 30 November, 2004).