CLINICAL TRAILS

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CLINICAL TRAILS

• Presented by
• RENISH R. DELVADIA
• L.M College of Pharmacy

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WHAT IS CLINICAL TRAIL?

• Clinical trail are the trails in which safety and
  tolerance limit of the drug is evaluated in to
  the animal or in the human being

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Why the clinical trails necessary

• Clinical trails are necessary for decreasing the
  mortality rate of the human due to unexpected
  toxicity of the newer molecule
• It has been told that if we omit the phase of the
  clinical trails than the total population of the
  world will be half of the current population

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How to get permission for CT

• Data of safety needs to be submitted
• Protocol need to submitted
• Strategy and planning need to submit

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Various phases of CT

• Preclinical trail ( in animal)
• Phase 1 (on healthy human volunteers)
• Phase 2 (on patient)
• Phase 3 (on patients and special population also)
• Phase 4 (Post marketing surveillances)

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Preclinical trails

• Objectives
• To evaluate the toxicity and safety of drug
• To interpret Initial tolerance level in to the
  human

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Preclinical trails

• Studies carried out at preclinical trail phase
• Development of the methodology for quantification
  of drug in plasma
• Mass balance-metabolite profile
• PK monitoring
• PK-PD relation
• Long term toxicity
• Protein binding
• Tissue distribution
• Placental transfer kinetic

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Phase 1 trail

• On the healthy 10-20 healthy volunteers
• First time dealing with human

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Phase 1 trail

• Objectives
• Determine the tolerability and acute toxicity
• Characterize PK (single and multiple dose)
• Dose-concentration-effect or toxicity relation
• To check Suitability of animal model
• Evaluate bioavailability

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Phase 1 trail

• Types of study
• Dose- concentration-effect or toxicity
  relationship (checking for linearity )
• IV single-dose study
• Radio active tracer study for study mass balance
• Evaluation of suitability of animal model
• Evaluation of drug formulation
• Effect of food
• Special population

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Phase 2

• First time we introduce drug to pateint
• Normally 100-200 patients are taken for trail
• Conducted in OPEN manner

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Phase 2

• Objectives
• For define most effective dose
• Collect the additional safety and PK data
• To check the difference in PK and PD in healthy
  volunteers and patient
• Careful monitoring more than one therapeutic or
  toxicity end point

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Phase 3

• Comparatively longer time require than phase 2
• Normally up to 1000 volunteers are taken for
  conducting trail

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Phase 3

• Objectives
• To identify less common side effect
• Comparison with standard therapy
• Study in special population
• Long term safety
• Long term effectiveness
• Study different dosage regimen
• Closer inspection of the drug interaction
• For developing the drug with multiindication

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Phase 4

• No specific planning
• 5000-10,000 patient are taken for trail
• Some rare problems may came out

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Drug labeling

• To advice the prescriber regarding the safe and
  effective use o the drug
• To individualized the drug therapy
• Gives information to clinician for choosing the
  correct dose for individual patient

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THANK YOU