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Good Clinical Practices

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Presentation outlining the importance of ethics while conducting clinical research

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  • DOWNLOAD FULL BOOKS INTO AVAILABLE FORMAT ......................................................................................................................... ......................................................................................................................... 1.DOWNLOAD FULL PDF EBOOK here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... 1.DOWNLOAD FULL EPUB Ebook here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... 1.DOWNLOAD FULL doc Ebook here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... 1.DOWNLOAD FULL PDF EBOOK here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... 1.DOWNLOAD FULL EPUB Ebook here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... 1.DOWNLOAD FULL doc Ebook here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... .............. Browse by Genre Available eBooks ......................................................................................................................... Art, Biography, Business, Chick Lit, Children's, Christian, Classics, Comics, Contemporary, Cookbooks, Crime, Ebooks, Fantasy, Fiction, Graphic Novels, Historical Fiction, History, Horror, Humor And Comedy, Manga, Memoir, Music, Mystery, Non Fiction, Paranormal, Philosophy, Poetry, Psychology, Religion, Romance, Science, Science Fiction, Self Help, Suspense, Spirituality, Sports, Thriller, Travel, Young Adult,
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Good Clinical Practices

  1. 1. GOOD CLINICAL PRACTICES DR. KARUN KUMAR JUNIOR RESIDENT – I DEPT. OF PHARMACOLOGY
  2. 2. What is Clinical Research ? •Research conducted on •Human subjects or •Material of human origin •Tissues, •Specimens, and •Cognitive phenomena http://keck.usc.edu/Research/Clinical_Research/Definition.aspx
  3. 3. What is Clinical Trial ? •Scientific studies •Test the effectiveness of •Treatment, •Device, or •Drug •Find new & better ways http://keck.usc.edu/en/Research/Clinical_Research/Clinical_Trials.aspx
  4. 4. Phases of Clinical Trial Phase Primary goal Dose Patient monitor Number of participants Preclinic al Testing of drug in non- human subjects Unrestricted A graduate level researcher-Ph.D. In vitro & in vivo animal models Phase 0 Oral bioavailability & half- life of drug Subtherapeutic Clinical researcher 10 people Phase I Testing of drug on healthy volunteers (safety) Subtherapeutic with asc. Doses Clinical researcher 20-100 Phase II Testing of drug on patients (efficacy & tolerability) Therapeutic dose Clinical researcher 100-300 Phase III Testing of drug on pts. (confirm efficacy) Therapeutic dose Clinical research. & Physician 1000-2000 Phase IV Post-marketing surveillance (A/E, D-D I) Therapeutic dose Physician Anyone seeking treatment Phase V Translational research No dosing None All reported use DeMets D., Friedman, L., and Furberg, C.,(2010).Fundamentals of Clinical Trials.Springer 4th Edition Goodman and Gilman's The Pharmacological Basis of Therapeutics, (2011) 12th Edition
  5. 5. What are Good Clinical Practices ? •More than any one document •Collective compilation of many •thoughts, •ideas and •learning moments spanning the globe over
  6. 6. •International ethical and scientific quality standard for •Design, •Conduct, •Performance, •Monitoring, •Auditing, •Recording, •Analysis, and •Reporting of clinical trials
  7. 7. Historical Background Year Event 460 B.C. Oath of Hippocrates 1930's U.S. Food, Drugs and Cosmetic Act 1947 Nuremberg Code Dec. 10th 1948 Declaration of Human Rights 1962 Kefauver-Harris Amendment 1964 Declaration of Helsinki 1979 The Belmont Report 1982 International Guidelines for Biomedical Research Involving Human Subjects (WHO & CIOMS) 1996 ICH-GCP guidelines issued 1997 ICH-GCP guidelines implemented Vijayananthan A, Nawawi O.The importance of Good Clinical Practice guidelines and its role in clinical trials.Biomed Imaging Interv J. 2008 Jan-Mar; 4(1).
  8. 8. The death sentences imposed in October 1946 were carried out by Master Sergeant John C. Woods (1903-50), who told a reporter from Time magazine that he was proud of his work. "The way I look at this hanging job, somebody has to do it . . . ten men in 103 minutes. That's fast work." http://www.history.com/topics/world-war-ii/nuremberg-trials
  9. 9. Brigadier General Telford Taylor, Chief of Counsel, during the Doctors Trial, which was held in Nuremberg, Germany, from December 9, 1946, to August 20, 1947.
  10. 10. During testimony at the Doctors Trial, American medical expert Dr. Leo Alexander points to scars on Jadwiga Dzido’s leg. Dzido, a member of the Polish underground, was a victim of medical experiments at the Ravensbrüeck concentration camp. Nuremberg, Germany, December 22, 1946.
  11. 11. Nazi physician Carl Clauberg who performed medical experiments on prisoners in Block 10 of the Auschwitz camp. Poland, between 1941 and 1944.
  12. 12. A prisoner in a compression chamber loses consciousness (and later dies) during an experiment to determine altitudes at which aircraft crews could survive without oxygen. Dachau, Germany, 1942.
  13. 13. Victim of a medical experiment immersed in freezing water at the Dachau concentration camp. Dachau, Germany, between August 1942 and May 1943.
  14. 14. A Romani (Gypsy) victim of Nazi medical experiments to make seawater potable. Dachau concentration camp, Germany, 1944.
  15. 15. Photo of wounds left by a medical experiment. The victim had been burned with phosphorous so that medicaments could be tested
  16. 16. Nuremberg Code (1947) •Voluntary consent of the human subject is absolutely essential •Favorable risk/benefit ratio •Research must help society •Research should be based on previous knowledge
  17. 17. •Participant must be free to stop at any time •Research should not cause mental & physical suffering •Research should avoid risk of injury & death
  18. 18. Declaration of Helsinki (1964) •Well being of subject > interest of science & society •Consent should be in writing •Limited use of placebo •Greater access to benefit
  19. 19. (April, 1979)
  20. 20. Respect for persons •Protecting autonomy of subjects •Treating subjects with courtesy and respect •Allowing for informed consent
  21. 21. Beneficence •The philosophy of "Do no harm” •Maximize benefits for the research project •Minimize risks to the research subjects
  22. 22. Justice •Ensure considered procedures are administered fairly •Fair distribution between •Burden of research (Costs) •Benefit of research
  23. 23. Common Rule (1981) •Describes the types of research subject(s) •Defines key terms such as •Research, •Human subject, and •Minimal risk
  24. 24. •Sets forth requirements for •IRB membership •Review procedures •Criteria for approval •Lists requirements for informed consent
  25. 25. Overview of Clinical research process Development of the trial protocol Development of standard operating procedures (SOPs) Development of support systems and tools
  26. 26. Selection of trial sites and the selection of properly qualified, trained, and experienced investigators and study personnel Ethics committee review & approval of the protocol Enrollment of subjects into the study:- Recruitment, Eligibility, & Informed consent Review by regulatory authorities
  27. 27. Safety management and reporting Trial data acquisition: conducting the trial The investigational product(s): quality, handling and accounting Monitoring the trial
  28. 28. Quality assurance of the trial performance and data Managing trial data Reporting the trial
  29. 29. WHO principles for GCP Principle 1 – Ethical Conduct •Research involving humans  Scientifically sound  In accordance with Declaration of Helsinki
  30. 30. Principle 2: Protocol •Research  To be described in a •Clear, •Detailed, and •“Scientifically justified” protocol
  31. 31. Principle 3: Risk Identification •Foreseeable risks and discomforts and any anticipated benefit(s)  To be identified
  32. 32. Principle 4: Benefit-Risk Assessment •Research initiated only if anticipated benefit(s) outweigh the risks •Most important considerations •Rights, •Safety, and •Well-being of trial subjects
  33. 33. Principle 5: Review by IEC/IRB •Research should receive independent (IEC/IRB) approval prior to initiation
  34. 34. Principle 6: Protocol Compliance •Research  Conducted in compliance with the approved protocol
  35. 35. Principle 7: Informed Consent •To be obtained •From every subject •Prior to research participation •In accordance with national culture(s) and requirements
  36. 36. Principle 8: Continuing review / ongoing benefit-risk assessment •Research  Continued only if the benefit-risk profile remains favorable
  37. 37. Principle 9: Investigator Qualifications •Qualified and duly licensed medical personnel  Responsible for the medical care of trial subjects
  38. 38. Principle 10: Staff Qualifications •Each individual involved should be qualified by •Education, •Training, and •Experience
  39. 39. Principle 11: Records •Clinical trial information should be •Recorded, •Handled, and •Stored
  40. 40. •In a way that allows its accurate •Reporting, •Interpretation, and •Verification
  41. 41. Principle 12: Confidentiality / Privacy •Confidentiality of records should be protected •In accordance with the applicable regulatory requirement(s)
  42. 42. Principle 13: Good Manufacturing Practice(s) •Investigational products should be •Manufactured, •Handled, and •Stored in accordance with applicable GMP
  43. 43. Principle 14: Quality Systems •Systems with procedures that assure the quality of every aspect of the trial should be implemented •Quality control (QC) •Quality assurance (QA) •Quality improvement (QI)
  44. 44. Code of Federal Regulations, Title 21 21 CFR 11: Electronic records and signatures 21 CFR 50: Protection of human subjects 21 CFR 54: Financial disclosure by clinical investigators
  45. 45. 21 CFR 56: IRB that oversee clinical trials 21 CFR 312: Investigational New Drug Application 21 CFR 812: Investigational Device Exemptions
  46. 46. ICH-GCP guidelines •“Bible” of clinical trials •Global law which safeguards humanity •13 core principles
  47. 47. Who is responsible for GCP ? •Each & every person involved in the research process. •This includes 1.Sponsors 2.Investigators and research staff
  48. 48. 3. Contract Research Organizations 4. IRB/EC 5. FDA 6. Research Subject
  49. 49. Never ending debate •Whether the "greater good" trumps the rights of the individual? •Are individual’s rights what make up the greater good? •Is it the greater good that allows for individual’s rights?
  50. 50. Take Home Message •"If it wasn't documented, it wasn't done.” •GCP is more than a piece of paper or a set of rules •A mind-set of dedication that ensures a high level of ethics & quality in research
  51. 51. THANK YOU

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