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Clinical Trials
Overview
Introduction
• Sets of tests in medical research and drug
development that generate safety and efficacy
data for health intervention
• i.e : information about adverse drug reactions
and adverse effects of other treatments.
e.g.: drugs, diagnostics, devices, therapy
protocols
Classification – Intervention
• Observational
• Interventional
Classification - Purpose
• Prevention trials
– medicines, vitamins, vaccines, minerals, or lifestyle changes

• Screening trials
– best way to detect certain diseases or health conditions

• Diagnostic trials
– Find better tests or procedures for diagnosing

• Treatment trials
– experimental treatments, new combinations of drugs, new
approaches to surgery or radiation therapy

• Quality of life trials/supportive care trials
• Compassionate use trials / expanded access trials
– partially tested, unapproved therapeutics to a small number of
patients who have no other realistic options
• (U.S. N.I.H. classification)
Phases – Drug development
T0

T1
Pre-Clinical
• Nonhuman
– Lab
– Animal (Rats , Primates , etc)

• Efficacy
• Toxicity
• Pharmacokinetics
Phases…
• Phase 0: Pharmacodynamics and
Pharmacokinetics
• Phase 1: Screening for safety
• Phase 2: efficacy of the drug, usually against a
placebo
• Phase 3: Final confirmation of safety and efficacy
• Phase 4: Post Market Surveillance
• Phase 5: Translational Research (Meta Analysis)
Phase 0
• First in Human Studies (FIH) /Proof of concept
studies (POC)
• Healthy subjects (10-15)
• Single sub therapeutic dose (human microdosing
studies)
• Preliminary Pharmacodynamics &
Phamacokinetics
• Usually skipped (asses with Phase 01)
Phase 1
• Volunteers(Healthy and Unhealthy) (20-80)
• 1st stage of testing human subjects
– Safety (Pharmacovigillance )
– Tolerance
– Pharmacodynamics and Pharmacokinetics
• Safe dosage
• Half life

• Types
– Single ascending dose studies
– Multiple ascending dose studies
– Food effect assements

• Therapeutic misconception
Phase 2
• Phase 2A (IIA)
– Assess dosing requirements

• Phase 2B (IIB)
– Study efficacy

• Study Design – Case Series ,RCT
• 100 -300 subjects
Phase 3
• Compare new treatments with the best currently
available treatment
– Confirms its effectiveness
– Monitor side effects

• Randomized controlled multicenter trials
• Drug licensing studies (Pre-marketing Phase)
• Large study groups (300- 3000 subjects)
Phase 4
• Postmerketing Surveillance
• Safety Surveillance
• Rare or long-term adverse effects over a much
larger patient population
• Harmful effects discovered by Phase IV trials
may result in a drug being no longer sold, or
restricted to certain uses
– Eg: Roficoxib
Phase 5
• Comparative effectiveness research and
community-based research
THANK YOU

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MD Paediatrics (Part 2) - Overview of Clinical Trials

  • 2. Introduction • Sets of tests in medical research and drug development that generate safety and efficacy data for health intervention • i.e : information about adverse drug reactions and adverse effects of other treatments. e.g.: drugs, diagnostics, devices, therapy protocols
  • 3. Classification – Intervention • Observational • Interventional
  • 4. Classification - Purpose • Prevention trials – medicines, vitamins, vaccines, minerals, or lifestyle changes • Screening trials – best way to detect certain diseases or health conditions • Diagnostic trials – Find better tests or procedures for diagnosing • Treatment trials – experimental treatments, new combinations of drugs, new approaches to surgery or radiation therapy • Quality of life trials/supportive care trials • Compassionate use trials / expanded access trials – partially tested, unapproved therapeutics to a small number of patients who have no other realistic options • (U.S. N.I.H. classification)
  • 5. Phases – Drug development T0 T1
  • 6. Pre-Clinical • Nonhuman – Lab – Animal (Rats , Primates , etc) • Efficacy • Toxicity • Pharmacokinetics
  • 7. Phases… • Phase 0: Pharmacodynamics and Pharmacokinetics • Phase 1: Screening for safety • Phase 2: efficacy of the drug, usually against a placebo • Phase 3: Final confirmation of safety and efficacy • Phase 4: Post Market Surveillance • Phase 5: Translational Research (Meta Analysis)
  • 8. Phase 0 • First in Human Studies (FIH) /Proof of concept studies (POC) • Healthy subjects (10-15) • Single sub therapeutic dose (human microdosing studies) • Preliminary Pharmacodynamics & Phamacokinetics • Usually skipped (asses with Phase 01)
  • 9. Phase 1 • Volunteers(Healthy and Unhealthy) (20-80) • 1st stage of testing human subjects – Safety (Pharmacovigillance ) – Tolerance – Pharmacodynamics and Pharmacokinetics • Safe dosage • Half life • Types – Single ascending dose studies – Multiple ascending dose studies – Food effect assements • Therapeutic misconception
  • 10. Phase 2 • Phase 2A (IIA) – Assess dosing requirements • Phase 2B (IIB) – Study efficacy • Study Design – Case Series ,RCT • 100 -300 subjects
  • 11. Phase 3 • Compare new treatments with the best currently available treatment – Confirms its effectiveness – Monitor side effects • Randomized controlled multicenter trials • Drug licensing studies (Pre-marketing Phase) • Large study groups (300- 3000 subjects)
  • 12. Phase 4 • Postmerketing Surveillance • Safety Surveillance • Rare or long-term adverse effects over a much larger patient population • Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses – Eg: Roficoxib
  • 13. Phase 5 • Comparative effectiveness research and community-based research

Editor's Notes

  1. Whether the drug reaches the cancerHow the drug behaves in the bodyHow cancer cells in the body respond to the drug
  2. The safe dose rangeWhat the side effects areHow the body copes with the drugIf the treatment shrinks the cancer