Evaluation of knowledge regarding good clinical practice among faculties at a tertiary care teaching hospital

Ashna S. Pandya, Pavan J. Panchal, Bhaven C. Kataria, Mitul R. Parmar

Abstract

Background: This study was aimed to assess the knowledge regarding basic aspects of conduct of clinical trial and associated regulatory as well as ethical issues before and after and educational intervention in form of a workshop on Good Clinical Practice (GCP).

Methods: One day workshop on “Good Clinical Practice” was planned which included important ethical and regulatory issues regarding clinical research. Various resource persons from industry and academia were chosen to address the workshop. Total 60 participants were enrolled for this one day workshop. Pre-workshop questionnaire of 15 questions were distributed before the actual topic started. Each participant had to fill the questionnaire form and return it within 15 minutes. Again at the end of workshop, post-workshop questionnaire containing the same questions were distributed and the participants were asked to fill the form. Sequence of questions was changed in post workshop questionnaire. Comparison between answers in pre and post workshop questionnaire was done. The primary outcome was knowledge, which was evaluated using the Wilcoxon signed rank test.

Results: In Pre workshop, out of 60, total 28 (46.66%) participants had answered all 15 questions, while 30 (50%) participants had skipped to answer one question “Define GCP.” 2 out of 6 (3.33%) participants had not answered 4 and 5 questions out of 15, respectively. Total 45 out of 60 (75%) participants in post workshop answered all questions. All 15 (100%) questions were answered correctly in post workshop as compared to 11 (73.3%) questions in pre workshop. So, in post-workshop, there were significant (P <0.005) gains in knowledge regarding all good clinical practice questions.  

Conclusions: Good clinical practice knowledge improved markedly with a targeted education intervention in form of workshop. However, changes in behaviour and attitude were not studied by this questionnaire based study.

Keywords

Clinical trial, Ethics, Questionnaires, Humans, Workshop

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References

Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: CIOMS; 2002. Available at: http://www.cioms.ch/publications/layout_guide2002.pdf. Accessed 15 February 2015.

European Medicines Agency. ICH harmonised tripartite guideline E6. In: EMA, eds. Note for Guidance on Good Clinical Practice (PMP/ICH/135/95). London: European Medicines Agency; 2002.

ICMR. Ethical guidelines for biomedical research on human participants. New Delhi: ICMR; 2006. Indian Council of Medical Research. Available at: http://icmr.nic.in/ethical_guidelines.pdf. Accessed 1 March 2015.

Vijaynathan A, Nawawi O. The importance of good clinical practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4(1):e5.

Sorensen GB, Kristensen AB. Knowledge of good clinical practice among Danish physicians: a questionnaire study among hospital employed physicians in the Copenhagen area. Ugeskr Laeger. 1997 Jan;159(4):414-8.

McCluskey A, Lovarini M. Providing education on evidence-based practice improved knowledge but did not change behaviour: a before and after study. BMC Med Educ. 2005;5:40.

Jha N, Bajracharya O, Shankar PR. Knowledge, attitude and practice towards medicines among school teachers in Lalitpur district, Nepal before and after an educational intervention. BMC Public Health. 2013;13:652.