MD Paediatrics (Part 2) - Overview of Clinical Trials

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Brief overview of Clinical Trials

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  • Whether the drug reaches the cancerHow the drug behaves in the bodyHow cancer cells in the body respond to the drug
  • The safe dose rangeWhat the side effects areHow the body copes with the drugIf the treatment shrinks the cancer
  • MD Paediatrics (Part 2) - Overview of Clinical Trials

    1. 1. Clinical Trials Overview
    2. 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. 3. Classification – Intervention • Observational • Interventional
    4. 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. 5. Phases – Drug development T0 T1
    6. 6. Pre-Clinical • Nonhuman – Lab – Animal (Rats , Primates , etc) • Efficacy • Toxicity • Pharmacokinetics
    7. 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. 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. 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. 10. Phase 2 • Phase 2A (IIA) – Assess dosing requirements • Phase 2B (IIB) – Study efficacy • Study Design – Case Series ,RCT • 100 -300 subjects
    11. 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. 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. 13. Phase 5 • Comparative effectiveness research and community-based research
    14. 14. THANK YOU

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