Keynote 1: Clinical Trials – First use in Man

Introduction

Hospital pharmacists are constantly faced with new drugs, frequently from biological origin. This can happen in the development stage (phase I and II trials) or for drugs coming into the market, where arguments on development are often used for marketing purposes.

The purpose of this session is to give some insight on how the development of new drugs goes from concept to first studies in man. How drug candidates are selected, what we have learned in the past and what are the lessons for the future. A critical aspect to be discussed is the first in man studies, i.e., the risks for Phase I trials. Issues of drug safety and particular cases of biologicals and targeted therapies are emphasised. Practical cases are discussed, focusing on drugs relevant to hospital environment.

Teaching Goals:

• review the key steps in new drug development prior to testing the drug in humans.
• present the most relevant issues related with the safety of people involved in early stage clinical trials, with focus on new therapeutic targets and the shortcomings of animal models.
• present examples of previous situations, with some focus on drugs that may be relevant to hospital pharmacy, that have proved relevant in shaping current thought on early stage clinical trials

Learning Objectives:

After the session, the attendees should:

• be able to summarise the key steps in new drug development prior to testing the drug in humans.
• be able to discuss in their own professional setting the most relevant issues related with the safety of people involved in early stage clinical trials (hospital or country level).
• have a basic knowledge about some critical events that have shaped current thought on early stage clinical trials