All About Clinical Trials - March 2015 - London - UK

1ST course :  All About Clinical Trials

27- 28 March 2015, in Royal College of Paediatrics & Child Health, Holborn, London

This programme is supported by an unrestricted educational grant from Daiichi Sankyo.

Course directors

Giuseppe MC Rosano, MD, PhD, FESC
Sven Wassmann, MD, PhD, FESC
Juan Carlos Kaski, DSc, DM (Hons), MD, FRCP, FESC

Clinical Trials: Day 1 - Welcome, introductions and course objectives -  G Rosano, S Wassmann,  JC Kaski

SESSION 1. HOW TO DESIGN A CLINICAL TRIAL

An overview of the different aspects of clinical trials - A Niessner

Traditional vs Novel Trial Designing – G Rosano

Clinical Trials: How to do them – BS Lewis

SESSION 2. REGULATORY ASPECTS

Requirements from regulatory agencies:  endpoints, comparators, type of studies - G Rosano

The role of the Research Office - L Parker

SESSION 3. HOW TO RUN A TRIAL EFFICIENTLY

The role of the principal investigator: keys to success, perils and tribulations - H Drexel

Clinical Trials: Practical Aspects - BS Lewis

SESSION 4. TRIAL CATEGORIES

Registries - G Mazzaglia

Randomised controlled Trials - A Niesser

Meta-analyses - R Kondapally

Clinical Trials: Day 2 (PRACTICAL WORKSHOPS)

SESSION 1. GOOD CLINICAL PRACTICE - Gill Lambert

Part 1

Part 2

SESSION 2. STATISTICAL ISSUES IN CLINICAL TRIALS – BASIC NOTIONS

My Learning Objectives - A Niesser

Statistical issues involving observational studies/registries and meta-analyses of RCTs - R Kondapally

Systematic Reviews - P Holt

SESSION 3. HOW TO INTERPRET CLINICAL TRIAL DATA

How to interpret clinical trial data – Sven Wassmann

SESSION 4. HOW TO WRITE A MANUSCRIPT: HOW TO MAKE THE MOST OF YOUR DATA

How to write a Research Article- G Rosano