AIBN Seminar Series FOUNDATIONS OF CLINICAL TRIAL METHODOLOGY

We are pleased to present Giovanni Della Cioppa, MD to speak on the topic FOUNDATIONS OF CLINICAL TRIAL METHODOLOGY.

When: Thursday 9th May

Where: AIBN Level 1 Seminar room or online via zoom, click here to join

Time: 1.30pm-2.30pm

Abstract

The goal of this presentation is to illustrate some of the basic concepts that underlie the methods we use in designing and assessing clinical trials, most of which are equally valid for other biomedical experiments. Throughout the talk, I will speak to your logical, not mathematical brain. Math is very important of course and the statistician is an essential component of any clinical trial team. But first and foremost, it is the ability to understand a precise logical framework, and possession of a familiarity with highly complex logistical settings, that are needed to be a good clinical trialist.

I will start with the sources of biological variability, which include measurement errors (random errors and systematic errors, also known as bias). I will then move to the classification and key features of clinical studies, with emphasis on the differences between observational and experimental studies and between descriptive and inferential reasoning. I will then cover the triad that contributes to any study result: chance, bias and true effect, and explain the meaning of the universally used, and often misused, p-value. Bias is a “killer” of the reliability of study results, and I will discuss the main antidotes against bias: pre-defined study protocol, randomization, and blinding. I will conclude my talk with an overview of the variables that determine the size of a clinical trial and explain why some trials need 30,000 subjects, while other well-designed clinical trials can get away with 20 or 30 subjects.

Bio:

Giovanni received his medical degree from the University of Naples, Italy, and holds postgraduate degrees in Internal Medicine and Pharmaceutical Medicine.

In 1990, Giovanni joined Novartis Pharma, where he held positions of increasing responsibility in Switzerland, the US and the UK, leading the clinical development of novel therapeutics in respiratory, dermatological and infectious diseases. Then, in 2007, he joined the Vaccines Division of Novartis, which was later acquired by GSK. From 2007 to 2015, Giovanni led the clinical development of several vaccines, including seasonal and pandemic influenza vaccines and vaccines against invasive meningococcal disease. In 2015, he was appointed Head of the Siena R&D Center, one of three GSK global centers devoted to vaccine research and development.

At the end of 2017, Giovanni made a big personal and professional change and became an independent clinical R&D consultant. Over the years, he has worked with numerous companies and organizations, including the Bill & Melinda Gates Foundation, the UK government, Novartis, GSK, Zambon and various start-up companies and, during the COVID-19 pandemic, was a member of the UK COVID-19 task force. In 2022, Giovanni joined Vicebio as consultant Chief Medical Officer and soon thereafter decided to drop other appointments to focus on Vicebio’s mission of developing innovative vaccines incorporating the University of Queensland’s molecular clamp technology.