Protecting patients in ongoing clinical trials

February 2010
CMAJ: Canadian Medical Association Journal;2/9/2010, Vol. 182 Issue 2, p124
Academic Journal
The article presents information on the efforts being undertaken by Health Canada, health care system in Canada to report the adverse events which occur in clinical trials. It discusses a case of John Dennis suffered an injury during clinical trials in Anapharm Inc., a clinical research firm in Canada. According to KPMG LLP., Quebec is one of the busiest clinical research sites in North America. It informs that the Canadian Association of Research Ethics Boards has not issued new guidelines.


Related Articles

  • Ethical Considerations for Acupuncture and Chinese Herbal Medicine Clinical Trials: A Cross-cultural Perspective*. Zaslawski, Christopher // Evidence-based Complementary & Alternative Medicine (eCAM);Sep2010, Vol. 7 Issue 3, p295 

    Many ethical concerns revolve around the four basic principles of research: merit and integrity, respect for human beings, weighting of risk–benefit and justice. These principles form the basis for any discussion concerning human research ethics and are applicable to all areas of research...

  • At Your Own RISK. Lemonick, Michael D.; Goldstein, Andrew; Park, Alice // Time;4/22/2002, Vol. 159 Issue 16, p46 

    Focuses on the risks associated with clinical trials in medicine. Debate about the safety regulations of the trials, which often involve desperately ill patients; Expectation that the number of trials will increase, and along with that, the number of deaths; Description of various scandals such...

  • THE LEGAL PROTECTION OF TEST SUBJECTS IN CLINICAL TRIALS OF MEDICINAL PRODUCTS FOR HUMAN USE IN THE EUROPEAN UNION. De Bijl, Nicole P. Y. M. // Medicine & Law (World Association for Medical Law);2004, Vol. 23 Issue 1, p1 

    On the international as well as on the level of the European Union a legal framework has been developed on the protection of test subjects has been developed. In 2000, the Declaration of Helsinki, issued by the World Medical Association, was revised and the previous distinction between...

  • Sham surgery controls are mitigated trolleys. Albin, R. L. // Journal of Medical Ethics;Mar2005, Vol. 31 Issue 3, p149 

    Debate continues about the ethics of sham surgery controls. The most powerful argument for sham surgery controls is that rigorous experiments are needed to demonstrate safety and efficacy of surgical procedures. Without such experiments, there is danger of adopting worthless procedures in...

  • When is an inducement 'undue?' Is a payment ever coercive?  // IRB Advisor;Sep2008, Vol. 8 Issue 9, p103 

    The article discusses the issue of paying people to participate in a clinical research and about inducement undue from a bioethical perspective. It outlines three main reasons why payments to study participants are a significant issue to investigators and institutional review boards. It also...

  • GENERATING KNOWLEDGE. Estcourt, Stephanie // Nursing Standard;6/10/2009, Vol. 23 Issue 40, p64 

    The article presents an overview of the role that research nurses play in clinical trials and of the challenges that they face as a result of medical ethics issues that are associated with clinical trials. The roles that clinical trials and research nurses play in the distribution of knowledge...

  • Medicines on trial: TGN1412 and the implications for future drug testing. Ainsworth, Steve // Nurse Prescribing;Apr2006, Vol. 4 Issue 3, p121 

    The article discusses the dangers, regulation and the ethical aspects of clinical trials in Great Britain. Many people would volunteer to be part of a clinical trial for monetary reasons. In some cases, clinical trials result to the death of some participants. The Medicines for Human Use...

  • Scientific empiricism and clinical medicine: a discussion paper. Baum, Michael // Journal of the Royal Society of Medicine;Jul1981, Vol. 74 Issue 7, p504 

    The author reflects on the problems that confront clinical experimentation. These problems include the concern with medical ethics and compassionate interest in the individual, the fear of questioning, the fear of litigation, and the sheer greediness of private practitioner. He argues that...

  • Reexamining transaminase elevation in Phase I clinical trials: the importance of baseline and change from baseline. Zhaohui Cai; Christianson, Anastasia M.; Ståhle, Lars; Keisu, Marianne // European Journal of Clinical Pharmacology;Oct2009, Vol. 65 Issue 10, p1025 

    The aims of the present analysis were to determine prevalence of transaminase elevation in placebo-treated healthy volunteers in our historical phase I clinical trials and to assess which factors were associated with it. We performed a retrospective analysis of alanine transaminase (ALT) levels...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics