1887
Volume 2016, Issue 1
  • EISSN: 2220-2749

Abstract

There is a significant lack of research regarding the knowledge, perception and attitude of health care professionals towards compliance with Good Clinical Practice (GCP) within the entire Arabic world. The present study intends to assess health care professionals’ knowledge, perception, and attitude towards compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines. A cross-sectional study was conducted at King Abdullah International Medical Research Center (KAIMRC) and King Abdulaziz Medical City (KAMC) in Riyadh. A self-administered questionnaire was used to assess the knowledge, perception, and attitude towards ICH-GCP in a sample of 78 health care professionals. The vast majority of the respondents 55(71%) were principal or co-investigators and 23(29%) were research coordinators. Almost all, 66(85%), of the respondents had received GCP training. Of 78 health care professionals, 98% reported that the research subjects provide voluntary consent and the study protocols give a clear and adequate description of the study procedures. 97% reported that GCP principles are followed in clinical trial studies and GCP compliant activities improve the quality of clinical research. Only 57% of the health care professionals reported that clinical research is a part of routine activities done in the clinic. 72% reported that they suffer from delay in the approval by the national IRB to start their research and 59% reported negative attitude towards the IRB approval process or monitoring and audit of the clinical trials. The present study suggests that the level of knowledge and perception towards compliance with ICH-GCP are generally satisfactory among health care professionals who involved in clinical trials in Saudi Arabia.

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2016-02-20
2024-03-28
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References

  1. Dal-Ré R. [Good clinical practice in clinical trials: The responsibilities of the investigator. A survey of 827 hospital physicians (and II). Patient consent]. Med Clin (Barc). 1993; 100:11:423427.
    [Google Scholar]
  2. Hock N. 4-C1-4: Preparing for FDA Bioresearch Monitoring (BIMO) and Good Clinical Research Practice (GCP) inspections: Fundamentals for KP clinical trial sites. Clin Med Res. 2013; 11:3:164.
    [Google Scholar]
  3. Toth-Allen J. Good Clinical Practice NIH Clinical Trial Seminar January 15, 2013 (Accessed 25 July 2015, at https://ccrod.cancer.gov/confluence/download/attachments/79958159/CT+Seminar+Series+Jan+2013+-+GCP.pdf).
  4. Ochieng J, Ecuru J, Nakwagala F, Kutyabami P. Research site monitoring for compliance with ethics regulatory standards: Review of experience from Uganda. BMC Medical Ethics. 2013; 14::23.
    [Google Scholar]
  5. Saito K, Kodama Y, Ono S, Fujimura A. Recent changes in quality in Japanese clinical trials. Ann Pharmacother. 2004; 38:1:151155.
    [Google Scholar]
  6. Hagimori N, Tasaki M, Kiyomatsu K, Tomiyasu M, Nagasawa K, Fujito H, Endo E, Takahashi K, Tamari K, Ushijima Y, Shiraishi K. Sponsor-based evaluation of the system for the execution of clinical trial at hospitals and related issues. Yakugaku zasshi: Journal of the Pharmaceutical Society of Japan. 2009 May; 129:5:537548.
    [Google Scholar]
  7. Gopinath NM, John J, Senthilkumar E, Nagappan N. Knowledge awareness and attitude about research ethics among dental faculties in India. J Contemp Dent Pract. 2014; 15:5:608613.
    [Google Scholar]
  8. Ibingira B, Ochieng J. Knowledge about the research and ethics committee at Makerere University, Kampala. Afr Health Sci. 2013; 13:4:10411046, [dx.doi:10.4314/ahs.v13i4.26].
    [Google Scholar]
  9. El-Dessouky H, Abdel-Aziz A, Ibrahim C, Moni M, Fadl RA, Silverman H. Knowledge, awareness, and attitudes about research ethics among dental faculty in the middle east: A pilot study. Int J Dent. 2011;694759.
    [Google Scholar]
  10. Glickman S, McHutchison J, Peterson E, Cairns E, Harrington R, Califf R, Schulman KA. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009; 360::816823.
    [Google Scholar]
  11. Kuusisto H, Virkki M, Wuolijoki E, Keränen T. Hospital training program increases awareness of Good Clinical Practice (GCP). Contemp Clin Trials. 2010; 31:5:438442.
    [Google Scholar]
  12. European Group on Ethics in Science and New Technologies to the European Commission. Opinion on the Ethical Aspects of Clinical Research in Developing Countries. Luxembourg: Office for Official Publications of the European Communities 2003.
    [Google Scholar]
  13. European Medicines Agency. Reflection Paper on Ethical and GCP Aspects of Clinical Trials of Medicinal Products for Human Use Conducted Outside of the EU/EEA and Submitted in Marketing Authorisation Applications to the EU Regulatory Authorities. London, UK: European Medicines Agency  2012; (Accessed 26 July 2013 at http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125437.pdf).
    [Google Scholar]
  14. Mgone C, Salami W. EDCTP: A genuine north-south partnership’. Trop Med Int Health. 2009; 14::13271328.
    [Google Scholar]
  15. Elie D. African networks launch to boost clinical trial capacity. Nat Med. 2010; 16::8.
    [Google Scholar]
  16. Ghiath A, Mohammad A, Kris D. Review of national research ethics regulations and guidelines in Middle Eastern Arab countries. BMC Medical Ethics. 2012; 13:1:34.
    [Google Scholar]
  17. Clinical Trials A service of the U.S. National Institutes of Health. Clinical Studies. (Accessed 26 July 2015 athttps://clinicaltrials.gov/ct2/about-studies/learn#ClinicalTrials).
  18. Paschoale HS, Barbosa FR, Nita ME, Carrilho FJ, Ono-Nita SK. Clinical trials profile: Professionals and sites. Contemp Clin Trials. 2011; 32:3:339341.
    [Google Scholar]
  19. Keinonen T, Keränen T, Klaukka T, Saano V, Ylitalo P, Enlund H. Pharmaceutical industry's barriers and preferences to conduct clinical drug trials in Finland: A qualitative study. Eur J Pharm Sci. 2003; 20::3542.
    [Google Scholar]
  20. Sather M, Raisch D, Haakenson C, Buckelew J, Feussner J, Department of veterans affairs cooperative studies program . Promoting good clinical practices in the conduct of clinical trials: Experiences in the Department of veterans affairs cooperative studies program. Control Clin Trials. 2003; 24:5:570584.
    [Google Scholar]
  21. Kasule O, Al-Kaabba A, Hussien G, Al-Othman H, Muhammed G. Final report (SRC) - The status and challenges of research on bioethics in the Arab world. Accessed 26 July 2015, at 2015 http://www.ksau-hs.edu.sa/english/research/documents/5thpsms201abstractslowres.pdf (G-07).
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  • Article Type: Research Article
Keyword(s): Clinical trials; Saudi ArabiaGood Clinical Practice and knowledge and attitude
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