Ahmed ZeeneldinAssociate Prof of Medical Oncology
ž Clinical   :  ¡ Humans  ¡ Human material  ¡ Identifiable dataž Preclinical:  ¡ Animal  ¡ Basic                   Ahmed Z...
ž   Practice:    ¡   Standard    ¡   approved    ¡   benefitž   Research: may not always benefit:    ¡   Non-standard    ¡...
ž Early      on:  ¡   Research and practice were mergedž Later      on:  ¡   Prior research had set routine care      ¢   ...
ž   Natural sources:    ¡   e.g. colics and herbsž   Manufactures :    ¡ Isolation    ¡ Purification    ¡ Medicinalization...
ž 2850 to 525 bc.ž Imhotep: ¡ surgery, ¡ dentistry, ¡ extracted   medicine from   plants, ¡ position and   function of the...
Ahmed Zeeneldin   8
Ahmed Zeeneldin   9
Ahmed Zeeneldin   10
ž Shen     Nung (2737 bc)  ¡ experimented with poisons  ¡ classified medical plantsž I.   Yin (1176–1123 bc),  ¡    extrac...
ž father of modern medicinež clinical inspection, observation,  and documentationž Hippocratic oath and high moral  standa...
ž Physician  of the Roman  Emperor Marcus Aurelius.ž First to do animal studiesž Transection of the spinal  cordž Describe...
‫‪ ž‬ﺗﺪاووا.. ﻓﺈن ﷲ ﺗﻌﺎﻟﻰ ﻟﻢ ﻳﻀﻊ داء إﻻ وﺿﻊ ﻟﻪ دواء..‬                             ‫ﻏﯿﺮ داء واﺣﺪ: اﻟﮫﺮم(‬                ‫...
‫‪ ž‬اﺑﻦ أﺑﻲ أﺻﯿﺒﻌﺔ - اﺑﻦ رﺑﱠﻦ اﻟﻄﺒﺮي - اﺑﻦ اﻟﺼﻮري - أﺑﻮ‬ ‫اﻟﺤﻜﻢ اﻟﺪﻣﺸﻘﻲ - اﺑﻦ ﺑﺎﺟﻪ - اﺑﻦ اﻟﺮﺣﺒﻲ - اﺑﻦ اﻟﻌﻄﺎر‬ ‫-أﺑﻮ ﻋﺜﻤﺎن...
‫‪ ž‬اﺑﻦ اﻟﻨﻔﯿﺲ:‬                  ‫¡ ﻗﺪم وﺻﻔًﺎ دﻗﯿﻘًﺎ ﻟﻠﺪورة‬                    ‫اﻟﺪﻣﻮﻳﺔ اﻟﺼﱡﻐْﺮَى ، ﻟﻢ‬                ...
‫‪ ž‬أﺑﻮ ﺑﻜﺮاﻟﺮازي :‬           ‫‪ ž‬واﺑﺘﻜﺮ ﺧﯿﻮط اﻟﺠﺮاﺣﺔ اﻟﻤﻌﺮوﻓﺔ ﺑﺎﻟﻘﺼﺎب،‬                       ‫‪ ž‬أول ﻣﻦ ﺻﻨﻊ ﻣﺮاھﻢ اﻟ...
‫‪ ž‬أﺑﻮ ﺑﻜﺮاﻟﺮازي :‬                           ‫‪ ž‬وﻧﺼﺢ ﺑﺄن ﺗُﺒﻨﻰ‬                  ‫اﻟﻤﺴﺘﺸﻔﯿﺎت ﺑﻌﯿﺪًا ﻋﻦ‬              ...
‫‪ ž‬أﺑﻲ اﻟﻘﺎﺳﻢ اﻟﺰھﺮاوي :‬              ‫اﺧﺘﺮاع أوﻟﻰ أدوات اﻟﺠﺮاﺣﺔ‬   ‫¡‬                      ‫ﻛﺎﻟﻤﺸﺮط واﻟﻤﻘﺺ‬          ...
‫‪ ž‬اﺑﻦ ﺳﯿﻨﺎ :‬                ‫اﻛﺘﺸﻒ ﻷول ﻣﺮة طﻔﯿﻞ‬          ‫¡‬       ‫)اﻹﻧﻜﻠﺴﺘﻮﻣﺎ(، وﺳﻤﺎھﺎ اﻟﺪودة‬                     ...
Ahmed Zeeneldin   21
Ahmed Zeeneldin   22
ž IgnazPhilipp Semmelweis (1818–1865)ž Death rate from puerperal fever (PF) was ¡ high in wards run by physicians (10%) ¡ ...
ž On  concentration camp inmates.ž Auschwitz, Polandž mass sterilization of females by injecting  caustics into uterusž Me...
ž Sigmund   Rascherž Pilots shot down in North Seaž 300 prisonersž immersed in ice-cold water, orž Strapped naked to a str...
ž Most were allowed to freeze to death;ž some resuscitation by various methodsž Active reheating in a warm bath proving th...
ž Eppinger,ž Forced 90 prisoners to drink only seawater for up to 12 days                Ahmed Zeeneldin         27
ž Germanyž 1947ž war crimes tribunalž Many Nazi doctors were  found guiltyž Some jailed, some excuted  and some suicided  ...
ž 1.   The voluntary consent of the human subject is absolutely essential.  ¡ Capacity  ¡ Free power of choice,  ¡ No cons...
ž 2.   Research Aim  ¡ Fruitful and good of society,  ¡ unprocurable by other methods or means of    study,  ¡ not random ...
ž   3. Trial to be based on prior knowledge    ¡ Animal studies    ¡ Natural history    ¡ Expected outcome to justify the ...
ž 7. precautions to protect patients from  injury, disability or deathž 8. Qualified personsž 9. Right to withdrawž 10. tr...
ž World Medical Associationž 1964 (18th general assembly )ž Helsinki, Finlandž Amendments: ¡   1975, Japan ¡   1983, Italy...
ž Ethical   rules  ¡ Humans  ¡ Human material  ¡ identifiable dataž Physician duty is to promote and safeguard  the health...
ž medical  progress needs researchž Subjects are more important than interests  of science and society.ž Aim:  ¡ improve p...
ž Respectfor all human beings and protect their health and rights. ¡   Vulnerable need special protection.ž Researchers sh...
ž Itis the duty of the physician in medical  research to protect the life, health, privacy,  and dignity of the human subj...
ž Protocol   is a must ¡ Review by independent body ¡ Ethical review committee (EC/ERC/IRB)ž The   research protocol shoul...
ž Risk/benefit assessmentž populations in which the research is carried  out stand to benefit from the results of the  res...
ž   Informed consent:    ¡   aims, methods,    ¡   sources of funding, any possible conflicts of interest,        institut...
ž Legally        incompetent, physically or mentally incapable: ¡ legally authorized representative ¡ Better avoid if poss...
ž Bothauthors and publishers have ethical obligations. ¡ Accuracy ¡ Negative as well as positive ¡ conflicts of interest ¡...
ž At   the conclusion of the study:  ¡   access to the best proven methods identified by      the study.ž refusalof a pati...
ž Placebo-controlled        trials ¡   Active copamparatorsž Post   therapy access to medications                  Ahmed Z...
ž At   the conclusion of the study:  ¡   access to the best proven methods identified by      the study.ž refusalof a pati...
ž Clinical trials consist of four phasesž the first three occur before a license is  granted andž the last is conducted as...
ž LABž ROOT   OF CLINICAL RESEARCH                Ahmed Zeeneldin   47
ž Animal  studiesž Safety and efficacyž How to assess first in human dose: ¡ NOAEL ¡ Human equivalent dose ¡ Safety factor...
ž primarily   determines:  ¡  how a medicine works in humans and  ¡ helps to predict the dosage range for the    medicine,...
ž testsefficacy as well as safety among:ž a small group of patients (100-300)ž with the condition for which the medicine  ...
ž involves a much larger group (1000-5000) of  these patients whichž Will help determine if the medicine can be  considere...
ž TRIALS  AFTER A LICENCEž Phase 4 trials are conducted after a medicine  has been granted a license.ž In these studies a ...
ž Phase   4 trials are performed to: ¡ Develop new treatment uses for the medicine. ¡ Compare with other treatments for th...
ž Could      fruits cure scurvy in sailors with scurvy when compared with other forms?ž Could hand washing prevent PF in w...
ž Practice:benefitž Research: may not always benefit  ¡ May receive highest care  ¡ May directly benefit  ¡ May be harmedž...
ž Because human beings should never be used “merely as means to an end, but always as ends in themselves,” the need to res...
ž Individualsare asked to take risk of harm or  burden To benefit others and societyž Exploitation?  ¡ Respect  ¡ Contribu...
ž Ideaž Question:    ¡   Population    ¡   Intervention, comparator    ¡   Outcomež   Literature search    ¡   Answered or...
Ahmed Zeeneldin   59
Clinical trials 2
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Introduction to clinical trials

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Clinical trials 2

  1. 1. Ahmed ZeeneldinAssociate Prof of Medical Oncology
  2. 2. ž Clinical : ¡ Humans ¡ Human material ¡ Identifiable dataž Preclinical: ¡ Animal ¡ Basic Ahmed Zeeneldin 2
  3. 3. ž Practice: ¡ Standard ¡ approved ¡ benefitž Research: may not always benefit: ¡ Non-standard ¡ Non-approved ¡ Benefit? ¢ May receive highest care ¢ May directly benefit ¢ May be harmedž Research gives Knowledge for better healthž Individual: respect, safety and dignity Ahmed Zeeneldin 3
  4. 4. ž Early on: ¡ Research and practice were mergedž Later on: ¡ Prior research had set routine care ¢ Clinicians ¡ Unanswered questions or unmet needs ¢ Researchers ¢ New practice Ahmed Zeeneldin 4
  5. 5. ž Natural sources: ¡ e.g. colics and herbsž Manufactures : ¡ Isolation ¡ Purification ¡ Medicinalization ¡ All patients: may respond or not (50/50)ž Targeting a disease process: ¡ e.g. hyperacidity and H2 receptos ¡ STI and TKI ¡ in a group of patients more likely to give a responsež Individualization: ¡ Genomes and proteomes ¡ e.g. gene insertion, cancer vaccines ¡ For the single patient with almost 100% success rate Ahmed Zeeneldin 5
  6. 6. ž 2850 to 525 bc.ž Imhotep: ¡ surgery, ¡ dentistry, ¡ extracted medicine from plants, ¡ position and function of the vital organs., Ahmed Zeeneldin 7
  7. 7. Ahmed Zeeneldin 8
  8. 8. Ahmed Zeeneldin 9
  9. 9. Ahmed Zeeneldin 10
  10. 10. ž Shen Nung (2737 bc) ¡ experimented with poisons ¡ classified medical plantsž I. Yin (1176–1123 bc), ¡ extraction of medicines from boiling plants. Ahmed Zeeneldin 11
  11. 11. ž father of modern medicinež clinical inspection, observation, and documentationž Hippocratic oath and high moral standards.ž 42 case records: ¡ malarial fevers, ¡ diarrhea, ¡ dysentery, ¡ mania, and ¡ Pulmonary edemaž Cleanliness: pure or boiled, hands and nails Ahmed Zeeneldin 12
  12. 12. ž Physician of the Roman Emperor Marcus Aurelius.ž First to do animal studiesž Transection of the spinal cordž Described structures: ¡ nervous system, ¡ heart, ¡ kidneys Ahmed Zeeneldin 13
  13. 13. ‫‪ ž‬ﺗﺪاووا.. ﻓﺈن ﷲ ﺗﻌﺎﻟﻰ ﻟﻢ ﻳﻀﻊ داء إﻻ وﺿﻊ ﻟﻪ دواء..‬ ‫ﻏﯿﺮ داء واﺣﺪ: اﻟﮫﺮم(‬ ‫‪Ahmed Zeeneldin‬‬ ‫41‬
  14. 14. ‫‪ ž‬اﺑﻦ أﺑﻲ أﺻﯿﺒﻌﺔ - اﺑﻦ رﺑﱠﻦ اﻟﻄﺒﺮي - اﺑﻦ اﻟﺼﻮري - أﺑﻮ‬ ‫اﻟﺤﻜﻢ اﻟﺪﻣﺸﻘﻲ - اﺑﻦ ﺑﺎﺟﻪ - اﺑﻦ اﻟﺮﺣﺒﻲ - اﺑﻦ اﻟﻌﻄﺎر‬ ‫-أﺑﻮ ﻋﺜﻤﺎن اﻟﺪﻣﺸﻘﻲ - اﺑﻦ اﻟﺒﻄﺮﻳﻖ - اﺑﻦ رﺷﺪ - اﺑﻦ‬ ‫اﻟﻘﺲ - أﺑﻮ اﻟﻔﺮج اﻟﯿﺒﺮودي - اﺑﻦ ﺑﻄﻼن - اﺑﻦ اﻟﻘﻒ - أﺑﻮ‬ ‫اﻟﻔﻀﻞ اﻟﺤﺎرﺛﻲ - اﺑﻦ اﻟﺒﯿﻄﺎر - اﺑﻦ اﻟﺴﺮاج - اﺑﻦ‬ ‫ﻛﺸﻜﺎرﻳﺎ - أﺑﻮ اﻟﻘﺎﺳﻢ اﻟﺰھﺮاوي - اﺑﻦ اﻟﺘﻠﻤﯿﺬ - اﺑﻦ‬‫ﺳﻌﺪ - اﺑﻦ ﻣﺎﺳﻮﻳﻪ - أﺑﻮ اﻟﻨﺼﺮ اﻟﺘﻜﺮﻳﺘﻲ - اﺑﻦ ﺗﻮﻣﺎ - اﺑﻦ‬ ‫ﺳﻘﻼب - اﺑﻦ اﻟﻤﺠﻮﺳﻲ - اﻹدرﻳﺴﻲ - اﺑﻦ اﻟﺠﺰار -‬‫اﺑﻦ ﺳﻤﺠﻮن - اﺑﻦ اﻟﻤﻘﺸﺮ - اﻟﺒﻐﺪادي - اﺑﻦ ﺟﺰﻟﺔ - اﺑﻦ‬‫اﻟﺴﻤﺢ - اﺑﻦ ﻣﻠﻜﺎ - اﻟﺒﯿﺮوﻧﻲ - اﺑﻦ ﺟﻠﺠﻞ - اﺑﻦ ﺳﯿﻨﺎ‬‫-اﺑﻦ ﻣﻨﺪوﻳﻪ - ﺛﺎﺑﺖ ﺑﻦ ﻗﺮة - اﺑﻦ اﻟﺨﻄﯿﺐ - اﺑﻦ اﻟﺼﺒﺎغ -‬ ‫اﺑﻦ ﻣﮫﻨﺪ - اﻟﺮازي - اﺑﻦ اﻟﺨﻮام - اﺑﻦ ﺻﻐﯿﺮ - اﺑﻦ‬ ‫اﻟﻨﻔﯿﺲ - اﺑﻦ اﻟﺨﯿﺎط - اﺑﻦ اﻟﺼﻼح - اﺑﻦ اﻟﮫﯿﺜﻢ -‬ ‫ﻣﻮﻓﻖ اﻟﺪﻳﻦ ﻋﺒﺪ اﻟﻠﻄﯿﻒ اﻟﺒﻐﺪادي - ﻋﺰ اﻟﺪﻳﻦ ﺑﻦ‬ ‫اﻟﺴﻮﻳﺪي - رﺷﯿﺪ اﻟﺪﻳﻦ ﻋﻠﻲ ﺑﻦ ﺧﻠﯿﻔﺔ - ﻋﻠﻲ ﺑﻦ‬ ‫رﺿﻮان - اﺑﻦ زھﺮ-‬ ‫‪Ahmed Zeeneldin‬‬ ‫51‬
  15. 15. ‫‪ ž‬اﺑﻦ اﻟﻨﻔﯿﺲ:‬ ‫¡ ﻗﺪم وﺻﻔًﺎ دﻗﯿﻘًﺎ ﻟﻠﺪورة‬ ‫اﻟﺪﻣﻮﻳﺔ اﻟﺼﱡﻐْﺮَى ، ﻟﻢ‬ ‫ﻳُﺴﺒَﻖْ إﻟﯿﻪ.‬‫‪Ahmed Zeeneldin‬‬ ‫61‬
  16. 16. ‫‪ ž‬أﺑﻮ ﺑﻜﺮاﻟﺮازي :‬ ‫‪ ž‬واﺑﺘﻜﺮ ﺧﯿﻮط اﻟﺠﺮاﺣﺔ اﻟﻤﻌﺮوﻓﺔ ﺑﺎﻟﻘﺼﺎب،‬ ‫‪ ž‬أول ﻣﻦ ﺻﻨﻊ ﻣﺮاھﻢ اﻟﺰﺋﺒﻖ،‬ ‫‪ ž‬وﻗﺪم ﺷﺮﺣﺎ ﻣﻔﺼﻼ ً ﻷﻣﺮاض اﻷطﻔﺎل، واﻟﻨﺴﺎء‬ ‫واﻟﻮﻻدة، واﻷﻣﺮاض اﻟﺘﻨﺎﺳﻠﯿﺔ، وﺟﺮاﺣﺔ اﻟﻌﯿﻮن‬ ‫وأﻣﺮاﺿﮫﺎ..‬‫‪ ž‬وﻛﺎن ﻣﻦ رواد اﻟﺒﺤﺚ اﻟﺘﺠﺮﻳﺒﻲ ﻓﻲ اﻟﻌﻠﻮم اﻟﻄﺒﯿﺔ،‬ ‫وﻗﺪ ﻗﺎم ﺑﻨﻔﺴﻪ ﺑﺒﻌﺾ اﻟﺘﺠﺎرب ﻋﻠﻰ اﻟﺤﯿﻮاﻧﺎت‬ ‫ﻛﺎﻟﻘﺮود؛ ﻓﻜﺎن ﻳﻌﻄﯿﮫﺎ اﻟﺪواء، وﻳﻼﺣﻆ ﺗﺄﺛﯿﺮه ﻓﯿﮫﺎ،‬ ‫ﻓﺈذا ﻧﺠﺢ طﺒﻘﻪ ﻋﻠﻰ اﻹﻧﺴﺎن..‬‫‪ ž‬وﻳُﻌَﺪﱡ اﻟﺮﱠازِي أول ﻣﻦ ﻗﺮر أن اﻟﻤﺮض ﻗﺪ ﻳﻜﻮن وراﺛﯿًﺎ.‬ ‫‪Ahmed Zeeneldin‬‬ ‫71‬
  17. 17. ‫‪ ž‬أﺑﻮ ﺑﻜﺮاﻟﺮازي :‬ ‫‪ ž‬وﻧﺼﺢ ﺑﺄن ﺗُﺒﻨﻰ‬ ‫اﻟﻤﺴﺘﺸﻔﯿﺎت ﺑﻌﯿﺪًا ﻋﻦ‬ ‫أﻣﺎﻛﻦ ﺗﻌﻔﱡﻦ اﻟﻤﻮاد‬ ‫اﻟﻌﻀﻮﻳﺔ‬ ‫‪ ž‬وﻳُﻌﺘَﺒَﺮُ اﻟﺮازي ﺳﺒﺎﻗًﺎ ﻓﻲ‬ ‫ﺗﺸﺨﯿﺼﻪ ﻟﻠﺠﺪري‬ ‫واﻟﺤﺼﺒﺔ، وﻗﺪ وﺿﻊ ﻟﺬﻟﻚ‬ ‫ﻛﺘﺎﺑﻪ اﻟﺸﮫﯿﺮ )اﻟﺠﺪري‬ ‫واﻟﺤﺼﺒﺔ(‬‫‪Ahmed Zeeneldin‬‬ ‫81‬
  18. 18. ‫‪ ž‬أﺑﻲ اﻟﻘﺎﺳﻢ اﻟﺰھﺮاوي :‬ ‫اﺧﺘﺮاع أوﻟﻰ أدوات اﻟﺠﺮاﺣﺔ‬ ‫¡‬ ‫ﻛﺎﻟﻤﺸﺮط واﻟﻤﻘﺺ‬ ‫اﻟﺠﺮاﺣﻲ‬ ‫رﺑﻂ اﻷوﻋﯿﺔ ﻟﻤﻨﻊ ﻧﺰﻓﮫﺎ‬ ‫¡‬ ‫اﻟﻮاﺿﻊ اﻷول ﻟﻌﻠﻢ اﻟﻤﻨﺎظﯿﺮ‬ ‫¡‬ ‫اﻟﺠﺮاﺣﯿﺔ‬ ‫أول ﻣﺨﺘﺮع وﻣﺴﺘﺨﺪم‬ ‫¡‬ ‫ﻟﻤﻨﻈﺎر اﻟﻤﮫﺒﻞ‬ ‫ﻛﺘﺎب : )اﻟﺘﺼﺮﻳﻒ ﻟﻤﻦ ﻋﺠﺰ‬ ‫¡‬ ‫ﻋﻦ اﻟﺘﺄﻟﯿﻒ( ‪ALTASRIF‬‬‫‪Ahmed Zeeneldin‬‬ ‫91‬
  19. 19. ‫‪ ž‬اﺑﻦ ﺳﯿﻨﺎ :‬ ‫اﻛﺘﺸﻒ ﻷول ﻣﺮة طﻔﯿﻞ‬ ‫¡‬ ‫)اﻹﻧﻜﻠﺴﺘﻮﻣﺎ(، وﺳﻤﺎھﺎ اﻟﺪودة‬ ‫اﻟﻤﺴﺘﺪﻳﺮة‬ ‫أول ﻣﻦ وﺻﻒ اﻻﻟﺘﮫﺎب‬ ‫¡‬ ‫اﻟﺴﺤﺎﺋﻲ‬ ‫طﺮﻳﻘﺔ اﺳﺘﺌﺼﺎل )اﻟﻠﻮزﺗﯿﻦ(،‬ ‫¡‬ ‫وﺗﻨﺎول ﻓﻲ آراﺋﻪ اﻟﻄﺒﯿﺔ أﻧﻮاﻋًﺎ‬ ‫¡‬ ‫ﻣﻦ اﻟﺴﺮطﺎﻧﺎت ﻛﺴﺮطﺎن‬ ‫اﻟﻜﺒﺪ، واﻟﺜﺪي، وأورام اﻟﻌﻘﺪ‬ ‫اﻟﻠﯿﻤﻔﺎوﻳﺔ‬ ‫ﻗﺎم ﺑﻌﻤﻠﯿﺎت ﺟﺮاﺣﯿﺔ دﻗﯿﻘﺔ‬ ‫¡‬‫‪Ahmed Zeeneldin‬‬ ‫02‬
  20. 20. Ahmed Zeeneldin 21
  21. 21. Ahmed Zeeneldin 22
  22. 22. ž IgnazPhilipp Semmelweis (1818–1865)ž Death rate from puerperal fever (PF) was ¡ high in wards run by physicians (10%) ¡ low in wards run by midwives (2-3%).ž Following death of a fellow after having a small cut wound during autopsy of a woman died of PFž Hand scrubbing with chlorinated lime water before entering the maternity wardž Mortality dropped from 9.92 % to 1.27% Ahmed Zeeneldin 23
  23. 23. ž On concentration camp inmates.ž Auschwitz, Polandž mass sterilization of females by injecting caustics into uterusž Men had mass irradiation followed by castration so that the testes could be examined.ž People were killed to collect skeleton gallery Ahmed Zeeneldin 24
  24. 24. ž Sigmund Rascherž Pilots shot down in North Seaž 300 prisonersž immersed in ice-cold water, orž Strapped naked to a stretcher in the Polish winter ¡ meticulously monitored for rectal temperature, heart rate, shivering level of consciousness Ahmed Zeeneldin 25
  25. 25. ž Most were allowed to freeze to death;ž some resuscitation by various methodsž Active reheating in a warm bath proving the most effective.ž results were presented at a medical conference in Berlin in 1942. Ahmed Zeeneldin 26
  26. 26. ž Eppinger,ž Forced 90 prisoners to drink only seawater for up to 12 days Ahmed Zeeneldin 27
  27. 27. ž Germanyž 1947ž war crimes tribunalž Many Nazi doctors were found guiltyž Some jailed, some excuted and some suicided Ahmed Zeeneldin 28
  28. 28. ž 1. The voluntary consent of the human subject is absolutely essential. ¡ Capacity ¡ Free power of choice, ¡ No constraint or coercion, ¡ Sufficient knowledge and comprehension. Ahmed Zeeneldin 29
  29. 29. ž 2. Research Aim ¡ Fruitful and good of society, ¡ unprocurable by other methods or means of study, ¡ not random and unnecessary in nature. Ahmed Zeeneldin 30
  30. 30. ž 3. Trial to be based on prior knowledge ¡ Animal studies ¡ Natural history ¡ Expected outcome to justify the trialž 4. avoid sufferingsž 5. Not when priori reason to believe that death or disabling injury will occurž 6. Risk should not exceed expected benefit Ahmed Zeeneldin 31
  31. 31. ž 7. precautions to protect patients from injury, disability or deathž 8. Qualified personsž 9. Right to withdrawž 10. trial termination when experiment is likely to result in injury, disability, or death to the experimental subject Ahmed Zeeneldin 32
  32. 32. ž World Medical Associationž 1964 (18th general assembly )ž Helsinki, Finlandž Amendments: ¡ 1975, Japan ¡ 1983, Italy ¡ 1989, Hong Kong ¡ 1996, South Africa ¡ 2000, Scotland ¡ 2002, Washington ¡ 2004, Japan Ahmed Zeeneldin 33
  33. 33. ž Ethical rules ¡ Humans ¡ Human material ¡ identifiable dataž Physician duty is to promote and safeguard the health of the peoplež A physician shall act only in the patients interest Ahmed Zeeneldin 34
  34. 34. ž medical progress needs researchž Subjects are more important than interests of science and society.ž Aim: ¡ improve prophylactic, diagnostic and therapeutic procedures and ¡ the understanding of the aetiology and pathogenesis of disease.ž 7. Most research involve risks and burdens Ahmed Zeeneldin 35
  35. 35. ž Respectfor all human beings and protect their health and rights. ¡ Vulnerable need special protection.ž Researchers should be aware of the ethical, legal and regulatory requirements Ahmed Zeeneldin 36
  36. 36. ž Itis the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.ž Research should be based on accepted scientific principles and thorough knowledgež Environment and animals Ahmed Zeeneldin 37
  37. 37. ž Protocol is a must ¡ Review by independent body ¡ Ethical review committee (EC/ERC/IRB)ž The research protocol should always contain: ¡ a statement of the ethical considerations involved and ¡ indicate that there is compliance with the principles of this Declaration.ž Qualified person ¡ Responsible for safety ¡ Not the subject even consenting Ahmed Zeeneldin 38
  38. 38. ž Risk/benefit assessmentž populations in which the research is carried out stand to benefit from the results of the research.ž The subjects must be volunteers and informed participants in the research projectž Subject: ¡ Respect, ¡ Privacy and confidentialityž Ahmed Zeeneldin 39
  39. 39. ž Informed consent: ¡ aims, methods, ¡ sources of funding, any possible conflicts of interest, institutional affiliations of the ¡ researcher, ¡ the anticipated benefits and potential risks of the study and the discomfort ¡ SIGN AND DATE ¡ Unable to sign: witnessed ¡ Copy to patient and another in the file ¡ WITHDRAWALž Who gets the consent: ¡ No dureness ¡ Dependency: treating doctor! Ahmed Zeeneldin 40
  40. 40. ž Legally incompetent, physically or mentally incapable: ¡ legally authorized representative ¡ Better avoid if possiblež Assentof child plus consent of legally authorized representative Ahmed Zeeneldin 41
  41. 41. ž Bothauthors and publishers have ethical obligations. ¡ Accuracy ¡ Negative as well as positive ¡ conflicts of interest ¡ Declaration compliance Ahmed Zeeneldin 42
  42. 42. ž At the conclusion of the study: ¡ access to the best proven methods identified by the study.ž refusalof a patient to participate in a study must never interfere with the patient- physician relationship. Ahmed Zeeneldin 43
  43. 43. ž Placebo-controlled trials ¡ Active copamparatorsž Post therapy access to medications Ahmed Zeeneldin 44
  44. 44. ž At the conclusion of the study: ¡ access to the best proven methods identified by the study.ž refusalof a patient to participate in a study must never interfere with the patient- physician relationship. Ahmed Zeeneldin 45
  45. 45. ž Clinical trials consist of four phasesž the first three occur before a license is granted andž the last is conducted as a post-licensing phase.ž Each phase varies in size, character and focus: Ahmed Zeeneldin 46
  46. 46. ž LABž ROOT OF CLINICAL RESEARCH Ahmed Zeeneldin 47
  47. 47. ž Animal studiesž Safety and efficacyž How to assess first in human dose: ¡ NOAEL ¡ Human equivalent dose ¡ Safety factor ¡ PREDICTABILITY Ahmed Zeeneldin 48
  48. 48. ž primarily determines: ¡ how a medicine works in humans and ¡ helps to predict the dosage range for the medicine, andž involves healthy volunteers (cancer chemotherapy is an exception). Ahmed Zeeneldin 49
  49. 49. ž testsefficacy as well as safety among:ž a small group of patients (100-300)ž with the condition for which the medicine has been developed. Ahmed Zeeneldin 50
  50. 50. ž involves a much larger group (1000-5000) of these patients whichž Will help determine if the medicine can be considered both safe and effective. Ahmed Zeeneldin 51
  51. 51. ž TRIALS AFTER A LICENCEž Phase 4 trials are conducted after a medicine has been granted a license.ž In these studies a medicine is prescribed in an everyday healthcare environment whichž allows results to be developed using a much larger group of participants. Ahmed Zeeneldin 52
  52. 52. ž Phase 4 trials are performed to: ¡ Develop new treatment uses for the medicine. ¡ Compare with other treatments for the condition. ¡ Determine the clinical effectiveness of the medicine in a much wider variety of patient types in conditions of “real life”. Ahmed Zeeneldin 53
  53. 53. ž Could fruits cure scurvy in sailors with scurvy when compared with other forms?ž Could hand washing prevent PF in women after delivery as compared with no hand washing? Ahmed Zeeneldin 54
  54. 54. ž Practice:benefitž Research: may not always benefit ¡ May receive highest care ¡ May directly benefit ¡ May be harmedž Research gives Knowledge for better healthž Individual: respect, safety and dignity Ahmed Zeeneldin 55
  55. 55. ž Because human beings should never be used “merely as means to an end, but always as ends in themselves,” the need to respect and protect human participants in research is paramount. Ahmed Zeeneldin 56
  56. 56. ž Individualsare asked to take risk of harm or burden To benefit others and societyž Exploitation? ¡ Respect ¡ Contribute not used ¡ Rights and welfare protected Ahmed Zeeneldin 57
  57. 57. ž Ideaž Question: ¡ Population ¡ Intervention, comparator ¡ Outcomež Literature search ¡ Answered or not answered ¡ Reinventing the wheel?ž Protocolž Scientific and ethical reviewž Conductž Publication Ahmed Zeeneldin 58
  58. 58. Ahmed Zeeneldin 59
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