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  1. Introduction to clinical trials Stefan Franzén

  2. Definition of a clinical trial A research activity that involves administration of a test treatment to some experimental unit in order to evaluate the treatment.

  3. Key words Treament Pharmaceutical, diet, procedure, diagnostic, device, program, placebo. Experimental unit Subject from a target population. Evaluate Assessment of (clinical) effect, but also adverse events, lab variables, vital signs, quality of life, health economy.

  4. The first study I have found two treats that makes a letcure seem more interesting. How do I find out which one is best?

  5. The Wheel of Science Experiment Research question Data Conlusion

  6. Drug discovery/development process discovery; refinement; chemical & biological characterisation safety & toxicity in animals; formulation development volunteer studies; patient studies regulatory process marketing Lessons & development post registration monitoring Discovery=find new active structure : Development=convert it to a useful drug

  7. The path to a new medicine 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Years First patent application Clinical trial application Product licenceapplication Drug Discovery Drug Development Target and leadidentification Leadoptimisation Developmentfor launch Product lifecycle support Concept testing Launch Clinical Development Phase I12-150people Phase II50-1000people Phase III500-5,000people Phase IV studies continue Toxicology and pharmacokinetic studies (absorption, distribution, metabolism, excretion) Pharmaceutical and analytical development Process chemistry and manufacturing Registration and regulatory affairs Sales and marketing (preparation, promotion, advertising and selling) No. of compounds Up to 10,000 10-15 1-8 1-3 1

  8. Phase I trials Phase I50-150people Phase III500-15000people Phase II100-200people Phase IV studies continue • Focused on tolerability and safety • 12-30 (150) healthy people (often males) • Efficacy on biomarkers • Single and repeated doses • Increase dose levels • Interaction with other drugs • Pharmacokinetics • Explorative

  9. Phase 2 trials Phase II50-1000people Phase I50-150people Phase III500-5,000people Phase IV studies continue • 50-1000 patients • Extensive monitoring • Safety and tolerability in patients • Often complicated design, explorative • Selection of optimal dose • Pharmacokinetics in patients • Effect in special populations • Explorative

  10. Phase 3 trials Phase III500-15000people Phase I50-150people Phase II100-200people Phase IV studies continue • 500-15000 patients • Effect is verified in the target population • Forms the basis of the NDA, New Drug Application • Interactions between drugs start to become measurable in the larger population • sub-groups start to be established • special features and problems show up • Confirmative

  11. Phase IV trials Phase I50-150people Phase II100-200people Phase III500-5,000people Phase IV studies continue • Often large 500-15000 patients • Further investigation of efficacy and safety post approval • Special populations • New indications • Marketing

  12. data collection analysis interpretation time now Observational studies Data is collected for a set of patients without any randomisation Prospective: Data is collected after the objectives are set data collection analysis interpretation time now Retrospective: Data is collected before the objectives are set

  13. Where to look for information ICH (international Conference on Harmonisation) http://www.ich.org/products/guidelines.html FDA (Food and Drug Agency) http://www.fda.gov/ EMEA (European Medicines Agency) http://www.emea.europa.eu/ Cochrane Collaboration http://www.cochrane.org/index.htm

  14. The Clinical Study Process Preparation of statisticalanalysis StatisticalAnalysis Outline Clinical StudyProtocol StudyConduct Clinical Study Report StudySetup Data Capture Publications StatisticalAnalysis Plan Clean File Data base lock T i m e

  15. Chapter 1 Reading instructions • 1.1 What are clinical trials: Read • 1.2 History of clinical trials: Less important • 1.3 Regulatory process and requirements: Read page 14 • 1.4 Investigational new drug application: Read page 17–20 • 1.5 New drug application: Less important • 1.6 Clinical development plan and practise: Read • 1.7 Aims and structure of this book: Skip