Trainer: Aaron Dane/DaneStat Consulting Limited
Webcast release Date: 03 September 2019
Webcast expiration Date: 03 September 2020
Duration: 1 hour
CME accreditation: UEMS-EACCME® 1.0 CME

Content

1. Clinical trial designs

• Superiority, non-inferiority, equivalence

2. Statistical terminology

• Null and alternate hypotheses
• Power, type I, type II error
• Standard deviation (SD), standard error (SE)
• p value, confidence interval (CI)
• Sample size

3. Design features of clinical trials

• Analysis pre-specification
• Randomization, stratified randomization, blinding
• Analysis sets: full analysis set (FAS), per protocol (PP) analysis set, safety analysis set
• Analysis of multiple endpoints

4. Methods of analysis and interpretation of clinical trials

• Measures of response: absolute and relative difference, odds ratio (OR), hazard ratio (HR)
• Key aspects of time-to-event studies
  • Hazard, HR, proportional hazards
  • Censoring
  • Sample size
  • Kaplan–Meier plots, waterfall plots
  • Log-rank test, stratified log-rank test, Cox’s proportional hazards

Learning objectives
After completing this module, participants should be able to:

• Describe the meaning of some commonly used statistical terms
• List reasons why certain design elements are important in clinical trial design
• Explain why certain trials are interpreted in a particular way

The webcast "An introduction to clinical trial statistics: biometry and statistics", made available on https://ologyeducation.org/acquire/ and organized by Ology Medical Education, is accredited by the European Accreditation Council for Continuing Medical Education (EACCME) to provide the following CME activity for medical specialists. Each medical specialist should claim only those credits that he/she actually spent in the educational activity. The EACCME is an institution of the European Union of Medical Specialists (UEMS). Only those e-learning materials that are displayed on the UEMS-EACCME website have formally been accredited. Through an agreement between the European Union of Medical Specialists (UEMS) and the American Medical Association (AMA), physicians may convert EACCME credits to an equivalent number of AMA PRA Category 1 CreditsTM. Information on the process to convert EACCME credit to AMA credit can be found at https://www.ama-assn.org/education/earn-credit-participation-international-activities.