Good Clinical Practice (GCP)

Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.

1. Good Clinical Practice (GCP) -Devyani Joshi

2. Definitions A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.  Good clinical practice is a set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible 

3. Purpose of GCP To harmonize the regulations and guidelines for the drug development.

4. Participants Regulatory agencies/ Industry representatives from Europe, Japan and US

5. Goal To remove redundancy / duplication in development of the review process For new medical product, the data should demonstrate: Safety Quality Efficacy

6. Process The developed guidelines were applicable for: - Drugs - Biologics - Medical devices Approved by ICH members Adopted by the National Regulatory Authorities

7. 1948 Nurenbuerg Code 1961 Thalidomide ( excl USA) 1962 USA – The Drugs Amendment Act – Established the IND procedure 1964 Worldwide – The Declaration of Helsinki (for protection of the trial subjects) 1968 UK – The Medicines Act (for the control of clinical trials and product marketing) 1976 Germany – The Drug Law 1978 USA – The FDA GCP Established 1986 UK – The ABPI Guidelines Issued

8. 1989 Nordic – GCP Guidelines Established 1991 France - decree giving Bonnes Pratiques Cliniques legal force 1991 European Community EC GCP Guidelines Operational 1991 Australian GCP 1993 WHO GCP Guidelines 1997 The ICH Guidelines on GCP Operational 2000 Worldwide – The DoH (declaration of Helsinki) Amended 2005 EU – “The GCP Directive” 2005 WHO – Handbook for GCP Guidance for implementation

9. Nurenbuerg Code Required is the voluntary, well-informed, understanding consent of the human subject in a full legal capacity. The experiment should aim at positive results for society that cannot be procured in some other way. It should be based on previous knowledge (like, an expectation derived from animal experiments) that justifies the experiment. The experiment should be set up in a way that avoids unnecessary physical and mental suffering and injuries. It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury. The risks of the experiment should be in proportion to (that is, not exceed) the expected humanitarian benefits.

10. The risks of the experiment should be in proportion to (that is, not exceed) the expected humanitarian benefits. Preparations and facilities must be provided that adequately protect the subjects against the experiment’s risks. The staff who conduct or take part in the experiment must be fully trained and scientifically qualified. The human subjects must be free to immediately quit the experiment at any point when they feel physically or mentally unable to go on. Likewise, the medical staff must stop the experiment at any point when they observe that continuation would be dangerous.

11. Declaration of Helsinki Research must conform to scientific principles Protocol and independent ethics committees Supervision and conduct of trial by suitably qualified persons Objectives and possible benefits balanced against risk to subjects Privacy respected and minimal physical and impact on the subject Informed consent

12. Good Clinical Practice (GCP) An international ethical and scientific quality standard for designing , conducting, recording, and reporting trials that involve the participation of human beings, Public assurance that the rights, safety, and well being of trial subjects are protected Results in credible data Consistent with the Declaration of Helsinki

13. Thirteen Principles of GCP Clinical trials should be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, that are consistent with GCP and the applicable regulatory requirements. Before the trial is initiated , foreseeable risks and inconveniences should be weighed against the anticipated benefits for the individual trial subjects and society. The trial should be initiated and continued only if the anticipated benefits justify the risks. The rights, safety and well – being of the trial subjects are the most important considerations and should prevail over the interest for science and society. The available clinical and non – clinical information on an investigational product should be adequate to support the proposed clinical trial. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

14. The trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB) / independent ethics committee (IEC) approval / favorable opinion. The medical care given to and medical decisions made on behalf of, subjects should always be the responsibility of the qualified physician or, when appropriate, a qualified dentist. Each individual involved in conducting the trials should be qualified by education, training and experience to perform his/ her respective tasks. Freely given informed consent should be obtained from every subject prior to the clinical trial participation. All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification.

15. The confidentiality of the records that could identify the trial subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements Investigational products should be manufactured, handled and stored in accordance with the applicable good manufacturing practices (GMP). They should be used in accordance with the approved protocol . Systems with procedures that assure the quality of every aspect of the trial should be implemented.

16. GCP = Quality data + Ethics

17. Thank you