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Introduction to Clinical Research              and     Good Clinical Practice    Ahmed Abdelmabood Zeeneldin     MD Medica...
Items to be covered• Clinical Research• GCP
Scientific Research• Observations• Relations• Workers• temperature• car-oil change
Clinical Research• Observations• Relations• Question? Is there a  relation between the time  of car-oil change and        ...
• Define measurement scales:   – Temp: degrees centigrade   – Time in minutes• Collect data• Test hypothesis              ...
Scientific research• Systematic investigation of hypothetical  propositions about the presumed relations  among observed p...
Clinical research• Scientific research• On  – humans or  – materials or  – data of human origin
Clinical research• Is there a relationship  between Eczema and  number of car-oil change  in workers?• Number of car-oil c...
Clinical and preclinical research
Clinical and preclinical research• Preclinical Research:   Ø Not in humans   Ø But will serve humans      Ø LAB      Ø Ani...
Why we do research?– To gain knowledge  • treat, prevent, diagnose diseases  • Human welfare  • Current and future patient...
Contributions to knowledge          Ahmed Zeeneldin    12
Why subjects engage in research? – To help their diseases – To help other patients – Other benefits:    • e.g. payment    ...
Is research beneficial to patients?• WE DO NOT KNOW:  – It could be beneficial    (Hopefully)  – It could prove harmful  –...
Research vs. routine practice• Practice:   – Standard   – approved   – benefit• Research: may not always benefit:   – Non-...
Study designs in health research• Observational:  – No intervention• Experimental:  – Intervention and outcome     • Semi-...
Study designs in Clinical Research• Observational:  – Research  – Not clinical trials• Experimental:  – Research  – As wel...
Observational studies• Cross-sectional• Case-control• Cohort                    Ahmed Zeeneldin   18
Cross-sectional studies• Example:  – Obesity and Skin cancer     •.  Total                          SKIN cancer  Obese    ...
Case-control studies• Example:  – Lung cancer and smoking in Gharbia               Lung cancer             No-lung cancer ...
Cohort studies ‫ﺟﻤﺎﻋﺔ‬• Example:  – Skin cancer following chest wall irradiation for    Breast cancer                     ...
Experimental Research               Interventional Research• Phase I• Phase II• Phase III:  – Randomized controlled trial ...
Experimental Research               Interventional Research• Phase I                        • Semi experimental• Phase II ...
Example of clinical trials• Use of Nigella Sativa oil in treatment of  metastatic malignant melanoma• ‫اﺳﺗﺧدام زﯾت ﺣﺑﺔ اﻟﺑ...
Question?• Why not going ahead and using this in all  patients ? ~ 100, 000
Steps• Preclinical R   – Lab: manufacturing and     purification, solubility and preservation   – Cell lines       • Effec...
Phases of clinical trials
Why we use trials?• Animal and human trials• Predictability of safety and efficacy• Animals:  – Safety prediction  – Disea...
Drug development cycle
Ethics in research
Preclinical Lab research• New viruses• New war weapons• Resistant microbes
Pre-clinical animal research• How long will guinea pig  live in atmospheric  temperature below 0°?• How long will a guinea...
Clinical research• How long will a human live in  atmospheric temperature  below 0°?• How long will a human live  under a ...
Clinical research• Are these trials  acceptable?• Is this clinical research  practice bad or good ?• BCRP• GCRP= GCP
Good Clinical Practice (GCP)• By GCP we mean:  – Set of standards for clinical research  – From design àconduct à monitori...
GCP1 Value (science),                         ،‫اﻟﻘﯾﻣﺔ‬2 Validity (quality),                    ‫ﺻﻼﺣﯾﺔ‬3 Fairness (justice...
GCP rules• Social and scientific Value:   – respond to health needs and   – provide a sound question whose answers will ad...
• Independent review:   – to ensure adherence to the ethical guidelines in design, conduct     and analysis.• Informed con...
BCP (Bad Clinical Practice)• Does skin exposure to car-  oil leads to skin cancer?• Orphan house• Deal with manager• Paint...
Good or badPoint                 Fulfill   Bad                      Good                      mentValue                 √ ...
Historical background of GCP460 BC   Oath of Hippocrates1930s   U.S. Food, Drugs and Cosmetic Act1947     Nuremberg Code (...
Goals of GCP• To protect the rights, safety and welfare of  humans participating in research• To assure the quality, relia...
The 13 principles of ICH-GCP• Ethics:  1. Ethical conduct of clinical trials  2. Benefits justify risks  3. Rights, safety...
The 13 principles of ICH-GCP• Responsibilities:  6. IRB/IEC approval prior to initiation  7. Medical care/decisions by qua...
The 13 principles of ICH-GCP• Data quality and integrity:  10. Accurate reporting, interpretation, and  verification  11. ...
Parties involved in research
Parties involved in research• Investigator• Subject• Sponsor• CRO• Ethics  committee• Regulatory  authorities
Summary• Scientific research• Clinical research• Clinical trials   – Phase I, II, III and IV• Ethics in research• GCP: sta...
Thank You        Ahmed A ZeeneldinDirector of Research Center (RCENCI)         Tel: 01111 000 943   Email: azeeneldin@gmai...
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Introduction to clinical research and gcp

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Introduction to clinical research and gcp

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  1. 1. Introduction to Clinical Research and Good Clinical Practice Ahmed Abdelmabood Zeeneldin MD Medical Oncology, Egypt Master of Clinical Research, UK
  2. 2. Items to be covered• Clinical Research• GCP
  3. 3. Scientific Research• Observations• Relations• Workers• temperature• car-oil change
  4. 4. Clinical Research• Observations• Relations• Question? Is there a relation between the time of car-oil change and • temperature?• Hypothesis? Increasing temperature decreases the time of car-oil change and temperature?
  5. 5. • Define measurement scales: – Temp: degrees centigrade – Time in minutes• Collect data• Test hypothesis 70 60 Temperature (oC) 50• Conclusion: 40 -increasing temp form 0-25 30 oC decreases time 20 10 -while increase above 25 oC 0 increases the time 0 10 20 30 Time (min) 40 50
  6. 6. Scientific research• Systematic investigation of hypothetical propositions about the presumed relations among observed phenomena.
  7. 7. Clinical research• Scientific research• On – humans or – materials or – data of human origin
  8. 8. Clinical research• Is there a relationship between Eczema and number of car-oil change in workers?• Number of car-oil change in workers – Limits: 16/day• Eczema – Limits: non-invasive (inspection and not biopsy) – Eczema score: area in CM x severity (0, 1, 2 3)
  9. 9. Clinical and preclinical research
  10. 10. Clinical and preclinical research• Preclinical Research: Ø Not in humans Ø But will serve humans Ø LAB Ø Animal
  11. 11. Why we do research?– To gain knowledge • treat, prevent, diagnose diseases • Human welfare • Current and future patients Ahmed Zeeneldin 11
  12. 12. Contributions to knowledge Ahmed Zeeneldin 12
  13. 13. Why subjects engage in research? – To help their diseases – To help other patients – Other benefits: • e.g. payment Ahmed Zeeneldin 13
  14. 14. Is research beneficial to patients?• WE DO NOT KNOW: – It could be beneficial (Hopefully) – It could prove harmful – It could prove of no benefit Ahmed Zeeneldin 14
  15. 15. Research vs. routine practice• Practice: – Standard – approved – benefit• Research: may not always benefit: – Non-standard – Non-approved – Benefit? • May receive highest care • May directly benefit • May be harmed• Research gives Knowledge for better health• Individual: respect, safety and dignity Ahmed Zeeneldin 15
  16. 16. Study designs in health research• Observational: – No intervention• Experimental: – Intervention and outcome • Semi-experimental • True-Experimental Ahmed Zeeneldin 16
  17. 17. Study designs in Clinical Research• Observational: – Research – Not clinical trials• Experimental: – Research – As well as clinical trials Ahmed Zeeneldin 17
  18. 18. Observational studies• Cross-sectional• Case-control• Cohort Ahmed Zeeneldin 18
  19. 19. Cross-sectional studies• Example: – Obesity and Skin cancer •. Total SKIN cancer Obese 350 (70%) Non-Obese 150 (30%) Total 500 (100%) Ahmed Zeeneldin 19
  20. 20. Case-control studies• Example: – Lung cancer and smoking in Gharbia Lung cancer No-lung cancer Smoking 450 (90%) 150 (30%) No-smoking 50 (10%) 350 (70%) Total 500 500 Ahmed Zeeneldin 20
  21. 21. Cohort studies ‫ﺟﻤﺎﻋﺔ‬• Example: – Skin cancer following chest wall irradiation for Breast cancer Breast CA+RT Breast CA- RT Skin cancer 10 (10%) 4 (1.3%) No-SKIN cancer 90 (90%) 296 (98.7%) Total 100 300 Ahmed Zeeneldin 21
  22. 22. Experimental Research Interventional Research• Phase I• Phase II• Phase III: – Randomized controlled trial (RCT)• Phase IV Ahmed Zeeneldin 22
  23. 23. Experimental Research Interventional Research• Phase I • Semi experimental• Phase II • Semi experimental• Phase III: • True experimental – Randomized controlled trial (RCT)• Phase IV Ahmed Zeeneldin 23
  24. 24. Example of clinical trials• Use of Nigella Sativa oil in treatment of metastatic malignant melanoma• ‫اﺳﺗﺧدام زﯾت ﺣﺑﺔ اﻟﺑرﻛﺔ ﻓﻲ ﻋﻼج ﺳرطﺎن اﻟﺟﻠد اﻟﺻﺑﻐﻲ اﻟﻣﻧﺗﺷر‬
  25. 25. Question?• Why not going ahead and using this in all patients ? ~ 100, 000
  26. 26. Steps• Preclinical R – Lab: manufacturing and purification, solubility and preservation – Cell lines • Effective or not – Animals • Safe or not? – Dose and frequency and duration AND Route • Efficacious or not?• Clinical R – Safe or not? à phase I – Efficacious or not? à phase II – More effective than current chemotherapy? à phase III• What is next?
  27. 27. Phases of clinical trials
  28. 28. Why we use trials?• Animal and human trials• Predictability of safety and efficacy• Animals: – Safety prediction – Diseases are different in animals: X efficacy• Humans: – Safety and efficacy prediction• Prediction is never perfect Ahmed Zeeneldin 28
  29. 29. Drug development cycle
  30. 30. Ethics in research
  31. 31. Preclinical Lab research• New viruses• New war weapons• Resistant microbes
  32. 32. Pre-clinical animal research• How long will guinea pig live in atmospheric temperature below 0°?• How long will a guinea pig live without food or water?• Carcinogenicity of car- oil on guinea pig skin?
  33. 33. Clinical research• How long will a human live in atmospheric temperature below 0°?• How long will a human live under a collapsed house without food or water?• This will decide the time rescuers will spend on searching?• Carcinogenicity of car-oil on human skin?
  34. 34. Clinical research• Are these trials acceptable?• Is this clinical research practice bad or good ?• BCRP• GCRP= GCP
  35. 35. Good Clinical Practice (GCP)• By GCP we mean: – Set of standards for clinical research – From design àconduct à monitoring/auditing à recording à analysis à reporting• Aspects of GCP – Science – Ethics – Quality
  36. 36. GCP1 Value (science), ،‫اﻟﻘﯾﻣﺔ‬2 Validity (quality), ‫ﺻﻼﺣﯾﺔ‬3 Fairness (justice), ‫اﻟﻌداﻟﺔ‬4 Risk– benefit ratio ‫ﻧﺳﺑﺔ اﻟﻣﺧﺎطر واﻟﻣﻧﺎﻓﻊ‬ (beneficence), (‫)اﻟﻣﻧﻔﻌﺔ‬5 Protocol and its ‫اﻟﺑروﺗوﻛول‬ Independent review, ‫اﻟﻣراﺟﻌﺔ اﻟﻣﺳﺗﻘﻠﺔ‬6 Consent, ‫اﻟﻣواﻓﻘﺔ اﻟﻣﺳﺗﻧﯾرة‬7 Respect ‫اﻻﺣﺗرام‬ (Emanuel et al. 2000) Belmont report, 1979.
  37. 37. GCP rules• Social and scientific Value: – respond to health needs and – provide a sound question whose answers will advance knowledge for the good of science and society.• Validity (Quality): – data generated from CR should be valid and interpretable through proper design, endpoints and methodology.• Fair subject selection: – being non-biased and based of scientific grounds.• Favorable risk– benefit ratio: – through minimization of vulnerability and risk as well as maximization of benefits.
  38. 38. • Independent review: – to ensure adherence to the ethical guidelines in design, conduct and analysis.• Informed consent: – the process that provides adequate information allows only voluntary participation. – Consent withdrawal should be allowed anytime in the research. – Consent does not deprive subjects from any of their rights nor does it alleviate researchers from their responsibilities in protecting safety, rights and welfare of subjects.• Respect for the enrolled subject’s: – autonomy, right and welfare both during and after research. – Individual’s rights and welfare should precede that of science and society
  39. 39. BCP (Bad Clinical Practice)• Does skin exposure to car- oil leads to skin cancer?• Orphan house• Deal with manager• Paint their skin with car-oil daily for 8 hours then wash• Do regular punch biopsied of the skin each month• Follow them without treatment for the rest of their lives
  40. 40. Good or badPoint Fulfill Bad Good mentValue √ Skin cancer following Skin cancer following exposure to car-oil exposure to car-oilValidity (design) X Artificial exposure Spontaneous natural exposureFair X Orphan house Oil station workersrisk– benefit ratio X No Tx allowed Tx allowedIndependent review X No YesConsent X No Yes Kids AdultsRespect X Withdrawal not allowed Withdrawal allowed
  41. 41. Historical background of GCP460 BC Oath of Hippocrates1930s U.S. Food, Drugs and Cosmetic Act1947 Nuremberg Code (following Nazi experiments in WWII)1948 Declaration of Human Rights1964 Declaration of Helsinki1979 The Belmont Report1982 International Guidelines for Biomedical Research Involving Human Subjects1996 ICH-GCP guidelines issued1997 ICH-GCP guidelines becomes law in some countries
  42. 42. Goals of GCP• To protect the rights, safety and welfare of humans participating in research• To assure the quality, reliability and integrity of data collected• To provide standards and guidelines for the conduct of clinical research
  43. 43. The 13 principles of ICH-GCP• Ethics: 1. Ethical conduct of clinical trials 2. Benefits justify risks 3. Rights, safety, and well-being of subjects prevail• Protocol and science: 4. Nonclinical and clinical information supports the trial 5. Compliance with a scientifically sound, detailed protocol
  44. 44. The 13 principles of ICH-GCP• Responsibilities: 6. IRB/IEC approval prior to initiation 7. Medical care/decisions by qualified physician 8. Each individual is qualified (education, training, experience) to perform his/her tasks• Informed Consent: 9. Freely given from every subject prior to participation
  45. 45. The 13 principles of ICH-GCP• Data quality and integrity: 10. Accurate reporting, interpretation, and verification 11. Protects confidentiality of records 12. Investigational Products Conform to GMP’s and used per protocol• Quality Control/Quality Assurance 13. Systems with procedures to ensure quality of every aspect of the trial
  46. 46. Parties involved in research
  47. 47. Parties involved in research• Investigator• Subject• Sponsor• CRO• Ethics committee• Regulatory authorities
  48. 48. Summary• Scientific research• Clinical research• Clinical trials – Phase I, II, III and IV• Ethics in research• GCP: standards or guidelines to ensure research is scientific, ethical and of good quality• Parties involved in research and their role and responsibilities
  49. 49. Thank You Ahmed A ZeeneldinDirector of Research Center (RCENCI) Tel: 01111 000 943 Email: azeeneldin@gmail.com Ahmed Zeeneldin 49
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