Compliance with the ICH-GCP Guidelines among the Saudi Health Care Professionals: Should Saudi Arabia Conduct Widespread ICH-GCP Training?

Abstract

Background: The guidelines governing the relationship between industry and medical institutions are clear in Saudi Arabia, but there are various deficiencies in the conduct of clinical trials in Saudi Arabia. The purpose of this study is to assess compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines among the health care professionals at the King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia. 

Methods: A cross-sectional survey was conducted at the KAMC. A questionnaire was administered to health care professionals involved in clinical trials between February 2014 and March 2015.

Results: The study shows poor compliance with the ICH-GCP principles. None of the 78 respondents responded correctly to various questionnaire items. The correct responses ranged from 40% to 90%. The research coordinators had better compliance with the ICH-GCP compared to the principal investigators (PIs) or the co-investigators (69.6% vs. 20%, p-value=0.001). Females (55.6% vs. 23.5%, p-value =0.005), and non-Saudi participants (45.5% vs. 20.6%, p-value =0.022) had better compliance. Multivariate logistic regression showed that the odds of compliance with GCP were 33.6 times higher among the research coordinators compared to the PIs or co-investigators. 

Conclusion: The study suggests that Saudi Arabia must conduct widespread ICH-GCP training to encourage better compliance among the Saudi researchers.