The course is aimed at the introduction of the methodological and regulatory principles of controlled clinical trials, useful both for anyone wishing to directly conduct the trials or operators involved in multicenter studies, and for anyone who simply wants to acquire a critical approach in the evaluation of new scientific evidences.
Covered topics range from the drafting of study protocol to the planning of study design, analysis of data and critical interpretation of the final results.
Particular attention is devoted to crucial aspects like sample size calculation, design of non-inferiority studies, and features of the design in cardiovascular safety trials.
Principles of good clinical practice are extensively treated, especially those concerning roles and responsibilities of the investigators and addressing regulatory issues relating to medical devices trials.
Finally, a session is dedicated to the critical reading of a paper reporting results of a clinical trial, providing learners with an evaluation grid that allows to determine the scientific validity and generalizability of study results.

TOPICS

  • Theoretical bases of clinical trials
  • Planning a clinical trial: the essential elements of a protocol
  • Methods of randomization
  • Conditions of blindness and placebo
  • The different types of experimental design
  • Controlled clinical trials: statistical issues
  • Sample size calculation
  • Non-inferiority and superiority trials
  • Statistical analysis of trial results
  • Data representation and summary measures
  • P-values and confidence intervals
  • Guide for a correct use of statistical tests
  • Univariate and multivariate analyses
  • Efficacy measures (relative and absolute risk, number needed to treat)
  • GCP: general overview
  • Critical reading of an article on the effectiveness of a treatment
  • Guide to the critical reading of a scientific article
  • Exercise in small groups: reading and evaluation of a scientific article