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Current good clinical practice (GCP) knowledge among investigators and employees of pharmaceutical company

by Lam, Wai-to

Abstract (Summary)
(Uncorrected OCR) Abstract Since the publication of the International Conference on Harmonization Guideline for Good Clinical Practice (ICH GCP) in 1996, no study has been done to investigate the level of the ICH GCP knowledge among researchers globally. The main objective of this study was to explore the level of the ICH GCP knowledge among investigators and employees in pharmaceutical companies across different regions and working sectors. The second objective was to survey the preference of study participants for receiving ICH GCP training program. A well-designed web-based questionnaire was sent to 28,558 medical researchers by e-mails between June and July 2004. The questionnaire consisted of 15 closed questions related to the principles and concept of the ICH Topic E6 Guideline for Good Clinical Practice, Questions included objectives of the ICH GCP, roles and responsibilities of different parties in a clinical trial, and concept of audit and inspection. Six Hundred and Sixty replies (Asia: 96; Australia and New Zealand: 39; Europe: 282; Africa: 18 South America: 51 North America: 164) were received. Participants who had replied the entire 15 questions were deemed analyzable for our study. Respondents from Australia and New Zealand (11.56 ?2.14) were found to have a significantly higher mean score (ANOVA one way, PO.001 than those from Asia (9.75+ 3.10), Europe (9.10 ?2.64) and South America (8.82+ 2.70). Employees from pharmaceutical industry (11.64 ?2.11) had a significantly higher mean score. (ANOVA one way, PO.001 versus employees working in Public Hospitals (9.54 ?2.65), Private Hospitals (9.10 ?2.62) and Governmental settings (8.48 ?2.78). A formal ICH GCP training was identified to be the major predictor of the level of the ICH GCP knowledge. 84.21 % of employees working in pharmaceutical companies had received the ICH GCP training, the highest percentage among all the working groups. For respondent's preference for receiving the ICH GCP trainings, 83.2% of principal investigators selected mandatory, followed by monitors at 82%. Surprisingly, only 35.7% of the respondents considered that GCP training be mandatory for statisticians. Overall, 46% of all the respondents preferred a web-based GCP training over other forms. The study showed that the level of the ICH GCP knowledge among different regions and working sectors varies significantly. Harmonization of GCP knowledge across different regions and working sectors is urgently needed to ensure that all clinical studies are conducted according to the ICH GCP guideline. Our study results also call for a globally recognized ICH GCP accreditation program. The ii implementation of a web-based GCP training program is considered to be the most welcoming approach to receiving GCP trainmg by survey participants.
Bibliographical Information:

Advisor:

School:The University of Hong Kong

School Location:China - Hong Kong SAR

Source Type:Master's Thesis

Keywords:clinical trials quality control pharmaceutical industry pharmacists medical audit

ISBN:

Date of Publication:01/01/2005

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