A SURVEY OF CANADIAN MEDICAL STUDENT ATTITUDES TOWARDS THE ETHICS OF PEDIATRIC CLINICAL TRIALS: ARE THEY DIFFERENT FROM CANADIAN AND BRITISH HEALTH CARE PROFESSIONALS?

Main Article Content

Dianna Wang
Allison L Bahm
Jamie A Seabrook
Helen M Sammons
Michael J Rieder

Keywords

Questionnaire, ethics, child, clinical trials

Abstract

Background


Due to ethical concerns and constraints inherent to research in children, the conduct of clinical trials in children has often been difficult. The views of medical professionals and trainees towards conducting clinical trials in children have been largely unexplored and are potentially important towards working to increase the number of appropriate trials conducted in children.


 


Objective


To explore the views of Canadian medical school trainees towards paediatric clinical trials and to compare these views with that of an earlier pilot study conducted amongst Canadian and British health care professionals.


 


Methods


Participants were given a questionnaire which consisted of direct questions as well as scenarios with ethical dilemmas. Responders were asked to state whether they would enter children in the trial documented in the scenario and to justify their reasons.


 


Results


89 questionnaires were collected (74% response rate). 42% had formal teaching regarding paediatric ethical dilemmas but only 2% had formal teaching on pharmaceutical testing in children. The students were divided on whether children should only participate in trials where they receive direct benefit. Most students (85%; 95% CI: 77% to 91%) were comfortable with non-inferiority trials even with post-hoc consent. Only a third (33%; 95% CI: 24% to 43%) agreed with the use of placebo in an analgesia trial.


 


Conclusion


Teaching on the ethics of paediatric clinical trials still appears to be lacking amongst medical trainees. However, there does seem to be increased willingness on the part of trainees compared to practicing medical professionals in enrolling children in clinical trials.

Abstract 160 | PDF Downloads 98

References

1. Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ. 2000; 320:79-82.
2. Meadows M. Drug research and children. FDA Consum 2003;Jan-Feb;12-17.
3. Burns JP. Research in children. Crit Care Med 2003;31(3)S131-136.
4. Caldwell PHY, Murphy SB, Butow PN, Craig JC. Clinical trials in children. Lancet. 2004;364:803-811.
5. Amiel P, Moreau D, Vincent-Genod C, et al. Noninvitation of eligible individuals to participate in pediatric studies. Arch Pediatr Adolesc Med 2007;161:446-450.
6. Sammons HM, Malhotra J, Choonara I, Sitar DS, Matsui D, Rieder MJ. British and Canadian views on the ethics of paediatric clinical trials. Eur J Clin Pharmacol 2007;63:431-436.
7. Raymond AS, Brasseur D. Development of medicines for children in Europe: ethical implications. Paediatr Respir Rev 2005;6:45-51.
8. Ethical considerations for clinical trials on medicinal products conducted in the paediatric population: Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use. 2008. http://ec.europa.eu/enterprise/pharmaceuticals/e udralex/vol-10/ethical_considerations.pdf (Accessed Nov 26, 2009).

Most read articles by the same author(s)