Understanding Clinical Trials and their Place in Health Technology Assessment: A Primer for Non-Statisticians

In today’s data driven healthcare environment, acquiring actionable knowledge from a vast ocean of information can be daunting. Decision makers at every level of healthcare must be able to find and understand clinical trial results to inform their work. In particular, decision makers in the field of health technology assessment must be able to incorporate that understanding into decisions about development, commercialization, and policy-making for specific health technologies.

This seminar will focus on how to find, assess, and interpret the Validity, Importance, and Actionability of clinical study results. Course attendees will become more knowledgeable of this “VIA” approach to understanding clinical trials in general, and to health technology assessment in particular.

Program Outline

I. Fundamentals of clinical research

• How do researchers formulate questions of efficacy, effectiveness or safety?
• What is clinical context?
• How are study designs selected?
• What is validity?
• Which study results are truly important?
• How actionable are a study’s findings?
• Why does it matter who funds the research?
• Where does the FDA fit in to this picture?

II. “Lies, damn lies, and statistics!”

• What does sample size mean?
• What is follow-up time?
• What is statistical significance and what does a p value really mean?
• What are odds ratios, hazard ratios, risk ratios, mean differences and confidence intervals?
• What’s all the fuss about post hoc analyses?
• What are regressions? And stratified analyses?
• What are meta-analyses?
• What is Bayesian analysis?
• How can all these be explained in plain English?

III. PANEL Discussion of applications of clinical evidence to support HTA decisions.