This document provides an overview of clinical research and good clinical practice (GCP) guidelines. It discusses how clinical research helps solve health problems and reduce costs by testing medications, devices, diagnostics, and treatment regimens. GCP standards provide ethical and scientific guidelines for clinical trials to increase quality, safety and participant protections. The history and development of GCP are reviewed internationally and in Indonesia, where GCP was adopted in 2001 with some adjustments and challenges remain around areas like informed consent and data management.

1. Clinical Study : a brief
explanation

2. “
Safety and efficacy is key for a
healthy life.
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3. Clinical Research
◉ Medications
◉ Devices
◉ Diagnostic products
◉ Treatment regimens
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4. WHY Clinical Research ??
◉ Solve health problems
◉ Reduce health care cost
◉ Improve scientific findings
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5. 5
www.mstrials.org.au

6. Regulations
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Production steps Regulation
Basic research Unregulated
Pre-clinical development Good Laboratory Practice
Clinical trials Good Clinical Practice
Manufacturing Good Manufacturing Practice

7. Good Clinical Practice
International ethical and scientific quality standard
for clinical trials
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8. Why GCP ?
◉ Increase ethical awareness
◉ Improve trial methods
◉ Better understanding of concept
◉ Public safety
◉ Frauds and accidents
◉ Research and development cost
◉ Competition
◉ New market structure 8

9. History of GCP
500 BC : King Nebuchadnezzar
1025 AD : Avicenna
1537 : Ambroise Pare
1747 : James Lind
1863 : Austin Flint
1943 : Medical Research Council UK
1946 : Medical Research Council UK
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(Bhatt 2010)

10. International guidance
1947 : The Nuremberg code
1948 : Universal declaration of Human rights
1946 : Helsinki declaration
1962 : Kefauer-Harris Amendment
1978 : The Belmont Report
1996 : International Conference of Harmonization
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(Bhatt 2010)

11. 11
European
Union
United
States
Japan
Australia
Nordic
countries
Canada
WHO

12. 12
Quality Safety
Efficacy Multidisciplinary

13. International Council for
Harmonization
◉ To achieve greater harmonization
◉ To maintain dialogue on scientific issues
◉ To contribute in protection of public health
◉ To monitor research and development
◉ To avoid divergent future requirements
◉ To facilitate technical research and development
◉ To encourage implementation of common standards
◉ And to develop policy for the ICH Medical Dictionary
for Regulatory Activities Terminology (MedDRA)
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14. 14
Indonesia

15. 2001
GCP adoption in Indonesia with some adjustments
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1982
Ethics committee was first established

16. GCP in Indonesia
◉ Food and drug supervision
◉ Formulate related policies
◉ Issue an authorization
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17. Legal Basis
◉ Health law no. 36/2009
◉ Government regulation no. 72/1998
◉ Decree of Minister of Health no 1010/2008 on Drug
registration
◉ Good Clinical Practice in Indonesia
◉ Decree of Head of NADFC 2002/SK/BPOM 2001 on
Clinical trial procedure
◉ Decree of Head of NADFC no HK.00.05.3.4991 2004 on
GCP inspections
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18. 18
www.centerwatch.com

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Strength
- Availability of hospitals and health
centers
- Manpower
- CROs, clinical laboratories
- Pharmaceutical industries
- Wide variety of diseases
Weakness
- Less standardized Ethics
Committee
- Some low quality clinical trials
- Lack of innovative spirit
Opportunity
- Needs of new drugs
- Large number of patients
- Research cost
- Many health problems
Threat
- Competing countries (Asia : China,
Thailand, Vietnam)
(Setiabudy 2015)

20. 20
Problems and Challenges Possible Solution
Accuracy, correction, and
completeness of CRF
Electronic data management
Lack of awareness in Informed
Consent
Public education
Poor product handling Implement standard treatment
guideline
Drug availability and price gap One-gate policy for drug supply
(Holloway 2011)

21. Thanks!
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22. Bhatt A. (2010). Evolution of Clinical Research: A History Before and Beyond James
Lind. Perspectives in Clinical Research, 1(1), 6–10.
Halloway KA. (2011). Indonesia : Pharmaceuticals in Health Care Delivery, Mission
Report for WHO.
ICH. (1996). Good Clinical Practice Guideline E6 (R1).
Setiabudy R. (2015). Clinical Research in Indonesia : Are We Ready?, Department of
Pharmacology, School of Medicine, University of Indonesia.
Siagian C. (2011). Practical Experience in CGP Inspection, non EU/EEA Countries :
Indonesia, EU CGP Inspectors Working Group Workshop.
Vijayananthan A, Nawawi O. (2008). The importance of Good Clinical Practice
guidelines and its role in clinical trials. Biomed Imaging Interv J, 4(1), e5 2.
Literature
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23. Elisabeth Kezia
Bachelor of Science
Faculty of Biotechnology
Atma Jaya Catholic University of Indonesia
More info me, contact kez.elisabeth@gmail.com
Or message me on 08999199821
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