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Good Clinical Practice - KSR

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By Ayurmitra Dr KSR Prasad

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Good Clinical Practice - KSR

  1. 1. Good Clinical Practice (GCP) Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP)
  2. 2. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Introduction • Clinical Research and Practice looks similar with variation – Research require to work in a stipulated frame work – Where in the practice is patient oriented /beneficial – The research do not require any clinical experience and it starts with a research question – but clinical practice do require clinical experience and regularity – To prevent undo practices in Clinical research and practice “Good Clinical Practice” is brought out 1
  3. 3. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Clinical Research • Research is – – A search for knowledge with Systematic investigation to establish facts in scientific manner • Clinical Research is – – Fact establishment in a clinic /hospital depending on direct observation of patients 2
  4. 4. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) What is Clinical trial • A clinical trial is a prospective evaluating the effect and value of intervention (s) in human beings under pre-specified conditions • A controlled clinical trial is a clinical trial comparing an intervention group against controls 3
  5. 5. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Good Clinical Practice Good Clinical Practice (GCP) is defined as – 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’ 4
  6. 6. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) GCP principles summary (1) • Patient – Rights, safety & well being of subjects prevail over interests of science and society – Individuals involved in trial should be qualified by education, training and experience to perform his/her tasks • Data – Information recorded, handled and stored to allow accurate reporting, interpretation and verification and confidentiality of subjects’ records 5
  7. 7. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) GCP principles summary (2) • Study – Trials shall be scientifically sound and guided by ethical principles in all their aspects – Necessary procedures to secure the quality of every aspect of the trial shall be complied with – Available non-clinical and clinical information shall be adequate to support the trial – Conducted according to Helsinki Declaration (1996) – Protocol shall provide inclusion and exclusion criteria, monitoring and publication policy – Investigator/sponsor shall consider all relevant guidance 6
  8. 8. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects • Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the • 29th WMA General Assembly, Tokyo, Japan, October 1975 • 35th WMA General Assembly, Venice, Italy, October 1983 • 41st WMA General Assembly, Hong Kong, September 1989 • 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 • 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 • Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002 7
  9. 9. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Declaration of Helsinki • Basic Principles – Concern for the interests of the subjects must always prevail over the interests of science and society. – Research must conform to accepted scientific principles; design appropriate and clear in experimental protocol. – Research must be conducted by qualified persons. – Research must have importance proportionate to inherent risk (risks acceptable given the benefits to individuals) – Safeguard subjects’ integrity & privacy. – Present results accurately in publications – Inform subjects of their right to withdraw. Obtain true informed consent from the subject or legal guardian. 8 41st World Medical Assembly, Hong Kong, September 1989.
  10. 10. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) 41st World Medical Assembly, Hong Kong, September 1989. • Medical Research Combined with Clinical Care (Clinical Research) – In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure – The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods – In any medical study, every patient should be assured – The physician can combine medical research with professional care – If the physician considers it essential not to obtain informed consent, the specific reasons for this – proposal should be stated in the experimental protocol for transmission to the independent committee (I.2). 9
  11. 11. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) 41st World Medical Assembly, Hong Kong, September 1989. • Non-Therapeutic Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research) – it is the duty of the physician to remain the protector of the life and health of that person, on whom biomedical research is being carried out. – The subjects should be volunteers --either healthy persons, or patients for whom the experimental design is not related to the patient's illness. – The investigator or the investigating team should discontinue the research, if in his/her or their judgment it may, if continued, be harmful to the individual. 10
  12. 12. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002 on Placebo controlled trial • Extreme care must be taken in making use of a placebo controlled trial and that in general this methodology should only be used in the absence of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances: – Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or – Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm. 11
  13. 13. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) GCP compliance • Who must comply with GCP? – All individuals involved in any aspect of the trial must be suitably ‘qualified’ to be able to comply with GCP. – Sponsors/CIs are responsible for ensuring that all staff are able to comply with GCP. • ICH GCP section 5.18.3 allows individual researchers to assess the needs of their trial and apply GCP appropriately ‘central monitoring in conjunction with procedures such as investigators’ training and meetings and extensive written guidance can assure appropriate conduct of the trial in accordance with GCP.’ (On-site monitoring not compulsory) 12
  14. 14. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) What counts as qualified? According to GCP each individual involved in conducting a trial ‘shall be qualified by education, training, and experience to perform his or her respective task (s)’ (GCP – principle 8) • Education • Training • Experience There is no GCP ‘qualification’ 13
  15. 15. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) GCP qualifications • Education – Clinicians must be clinically qualified – Statisticians must be qualified – Managers must be appropriately educated • Training – Employer induction courses – Industry courses – E-learning (Institute of Clinical Research) – Private courses (usually run by freelance consultant) – Host institution courses – Trial specific workshops – Investigators meetings • Experience – Discovering what is required – Doing the job (sometimes wrongly) – Cascading information and knowledge through teams/units – Conversation to other trial makers 14
  16. 16. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Approvals and permissions • Ethics committee approval • Clinical Trials Authorisation • R & D permission • Sponsor approval 15
  17. 17. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Informed consent • Following the second world war and the Nuremberg trials, the Nuremberg Code and Declaration of Helsinki was agreed worldwide as a charter to protect people/patients against human experimentation – Up until 1995 USA, Japan and Europe worked to different standards in the conduct of clinical trials – 1995 ICH-GCP was implemented – a global standard – 2001 EU Directive set out regulations for clinical trials of medicines conducted within the EU – 2004 (May) the UK implemented the Directive and the UK Regulations became law Informed consent – personal autonomy ‘…a competent individual should have the right to determine those discretionary risks he/she is willing to accept for whatever benefits he/she perceives may result.’ 16
  18. 18. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Consent procedures • Given freely • Face to face • Telephone • Watch • Listen • Learn • What works well? • Share 17
  19. 19. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Good Clinical Practice (E6) • The GCP document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors and sponsors. • GCP covers the aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the essential documents and on the investigators broacher which had been agreed earlier through consent process. 18
  20. 20. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) 19
  21. 21. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) 20
  22. 22. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) 21
  23. 23. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) • Phase 1 – First use in humans (healthy or ill) – Physiological observations (pre-clinical status) – Tolerance of different dosages – Finding optimal dose-relationship – Interactions with other treatments – Pre-finding of clinical indication • Phase 2 – Dose-relationship in patients – Treatment efficacy compared to an other method or substance – Tolerance proof of dose (s) – Physiological observations of phase I results – Interactions with other treatments – Real finding of indication 22
  24. 24. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) • Phase 3 – Treatment efficacy compared to another method or substance – Give reasons for effect (power, number of cases) – Tolerance proof of dose (s) – Physiological observations of phase I&II results – Interactions with other treatments – Confirmation interactions to be registered • Phase 4 – Additional findings under conditions of daily use – Periodic safety update to keep marketing authorization (Vigoxx©, Lipoxx©) – Impressions about new indication (s) 23
  25. 25. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Designs of study • Randomized clinical trial • Parallel group design • Crossover design • Multi center studies (trials) • Active control trial – Superiority trial (new advances) – Equivalence or non inferiority trial (safety purpose) 24
  26. 26. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Principles of Research • Randomization principle • Blindness principle – Single / Double • Placebo principle • Intent to treat principle 25
  27. 27. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) 26
  28. 28. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Follow - • CONSORT checklist • Show proper reporting effects – Acknowledgements – Statistics 27
  29. 29. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Good Clinical Practice (GCP) Acknowledgements • GCP - J. Hedderich - Institut für Medizinische Informatik und Statistik • UKTMN • MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS, March 1998, Medical Research Council, 20, Park Crescent, London, W1N 4AL 28

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