Linked to EAHP Statements

Statements: 

Section 5 – Patient safety and Quality Assurance: Statements 5.1, 5.2
Section 6 – Education and Research: Statements 6.2, 6.4, 6.5

ACPE UAN: 0475-0000-18-024-L04-P. A knowledge based activity.

Abstract

The collaboration of hospital pharmacists in the process of Clinical Trials is a very important area of operations. Hospital pharmacists all over Europe already work in this innovative and challenging workspace. However, for most hospital pharmacists up to now this was in most cases limited to clinical studies in adults. Organizing clinical studies in the population of paediatric haemato-oncological patients is different and indeed a challenge for hospital pharmacists. The speakers in this seminar will discuss these differences in terms of preparation of clinical trial drugs for children and the legal environment around this population in clinical trials.

Learning objectives

After the session, the participant should be able to:

• To name the differences between clinical studies in adults and children;
• To outline the legal environment and discuss problems of administrations of drug clinical trials in children;
• To describe the differences in preparation of clinical trial drugs for children; and, 
• Avoid getting lost in the jungle of legal environment of clinical trials in children

Educational need addressed

In those days now the overall cure rates for children with malignancies is about 75%. But what about the remaining 25%? Only about 10% of the relapsing patients can be cured up to date. That is the reason for the strenuous efforts researchers all over the world make. Hospital pharmacists have to support those efforts and have to gain knowledge on how to support clinical studies in the field of cancer, especially in the field of hemato-oncology.

Keywords: clinical trial, paediatric, haemato-oncology, children