Good clinical practice (thira) 2013

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For postgraduate MDCU students.

For postgraduate MDCU students.

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  • 1. Thira Woratanarat MD MMedSc MACEDepartment of Preventive and Social Medicine,Faculty of Medicine, Chulalongkorn University
  • 2.  GCP: “What is in your mind?” Overview of drug development/clinical trial process What happened in the old times? Forms of research misconduct Introduction to GCP
  • 3. การปฏิบติทาง ั คลินิกที่ดี Good Clinical Practice Good Clinical Research Practice การวจยทาง ิั คลินิกที่ดี Gemogelt (โกง)…Copy…Publish…
  • 4. 1. Drug Discovery 2. Early Development (Pre-clinical, IND, Phase I and Early Phase II) 3. Advanced Clinical Trials (Phase III) 5. Post-Marketing Strategies 4. Drug Registration (Phase III-b and IV) and Approval
  • 5.  Tuskegee trials - 1930s German prisoners trials - 1940s Harvard fraud - 1980s Thailand: how many?
  • 6.  > 600 men with syphilis  50% randomized to treatment  50% randomized to NO TREATMENT  Result: Untreated patients fared poorly A significant number of patients died No information given to patients; no permission was sought to withhold treatment; no clear endpoints. Outcome: Litigation, financial settlements 16 May ‘97: Public apology from U.S. President Clinton; support for lasting bioethics reforms “…..the definitive example of an unethical study”
  • 7.  Objectives of various trials:  Effect of cold, heat, chemicals on men, women and children  “Time to death” testing in response to stressors in healthy “volunteers”  Organ transplant experiments on healthy “volunteers” Any information given is irrelevant because prisoners were forced to participate Outcome:  25 German scientists taken to court, 7 acquitted, 9 imprisoned, 9 given death sentence  Nuremberg Code of 1947
  • 8.  CV Training Fellow tutored by Dr. Eugene Braunwald, prominent U.S. cardiologist Fellow fabricated study data; discovered because of “too clean” data & intact dogs in the dumpster Outcome for fellow: License withdrawn; expelled from Harvard; “blackballed” from research Outcome for Braunwald/Harvard: Written public apology; retracted papers, great embarrassment resulting from questioned credibility of past and future work
  • 9.  Obfuscation - The Omission of critical data or results Fabrication – the actual making up of research data and (the intent of) publishing them, sometimes referred to as “drylabbing” Falsification – manipulation of research data and processes in order to reflect or prevent a certain result
  • 10.  Plagiarism Self-plagiarism or “Multiple publication” Matthew effect’s intention Violation of ethical standards Ghostwriting data user
  • 11. GCP = Regulations
  • 12.  Regulations contained in 21 CFR Part 50, 56, and 312 Part 50 (applies to consenting of subjects), Part 56 (applies to IRB responsibilities) and Part 312 (applies to IND submissions, sponsor responsibility, and investigator responsibility)
  • 13.  An international ethical & scientific quality standard for designing, conducting, recording & reporting human clinical studies  EU  Japan  US Applies to registration studies that may have an impact on safety & welfare of human subjects Based on the Declaration of Helsinki
  • 14.  IRB/Ethics Committee Investigators Sponsor Regulatory Authorities
  • 15. 40% 36% 34%35% 31%30% 27% 25%25% 22% 22%20% Foreign Domestic15% 12% 9%10% 7% Foreign n = 36 Domestic n = 2335%0% Protocol Records Consent Drug Acct AEsDSI, 10/22/02
  • 16. ICH: “Perfect World” for Clinical Trials
  • 17.  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 = Quality Data the Rights, Integrity, and Confidentiality of Trial Subjects are Protected = Ethics
  • 18. 1. Know and follow the study protocol2. Select, train and log suitable study personnel3. Record data carefully4. Ensure study equipment is adequate5. Maximise trial patients protection6. Predict accurately and log patient recruitment7. Meticulously document product accountability8. Ensure timely and efficient safety reporting9. Ensure the quality of lab evaluations10. Maintain good trial files and archives11. Maximise data quality12. Keep everyone fully informed
  • 19. 1. Know and follow the study protocol  read it  agree to it  sign it  follow it  file it
  • 20. 2. Select, train and log suitable study personnel  log  CV’s  Information Study Personnel Log CV’s
  • 21. 3. Record data carefully
  • 22. 4. Ensure study equipment is adequate  SCAM
  • 23. 5. Maximise trial patients protection  Ethics  Consent IEC Approval
  • 24. 6. Predict accurately, log patient recruitment  no guessing  log screened and recruited patients  patient withdrawal
  • 25. 7. Document product accountability
  • 26. 8. Ensure timely and efficient safety reporting  Adverse Events  Serious Adverse Events (ICH GCP)  results in death  life threatening  requires hospitalisation  prolongs hospitalisation  results in disability  congenital anomaly / birth defect
  • 27. 9. Ensure the quality of lab evaluations
  • 28. 10. Maintain good trial files and archives
  • 29. 11. Maximise data quality  Source Data Verification
  • 30. 12. Keep everyone fully informed  Communication
  • 31.  Standard Operating Procedures (SOP’s)  company specific requirements which can be replicated  interpretation of GCP by companies  set of rules, instructions, specific requirements
  • 32. 1. Thou shalt write legibly2. Thou shalt include the date and time3. Thou shalt sign thy name4. Thou shalt not use OUA5. Thou shalt not alter an entry or disguise an addition
  • 33. 6. Thou shalt not use offensive, personal or humorous comments7. Thou shalt check everything written in your name – before you sign it off8. Results should be seen, evaluated and initialled by the clinician before filing9. Thou shalt make sure that someone in authority understands these regulations10. Thou needs to know how to manage these rules!!!!!
  • 34.  Use qualified support staff Obtain informed consent Record information appropriately Protect confidentiality Handle investigational products appropriately Implement quality systems
  • 35.  Vulnerable participants  May have a legal representative Underage participants  Must have a parent or legal guardian sign the consent form  Depending on the age of the subject, assent may be required Problems with literacy  A witness must be present