What makes pediatric research different? (August 29, 2007) Category: Children in research

I may be asked to give a repeat performance of Stats #53: Signal Detection Strategies for Paediatric Treatments. This is a three hour class that I gave last year in London. A different group is interested in pretty much the same topic. Looking at the title and abstract, I am a bit uncomfortable with it, so here's an alternative.

Some possible titles are

• What makes pediatric research different? or
• Assessing the safety of pediatric treatments

I'll work with the group that is inviting me to see what they like. An abstract of the talk could be something like:

Content:  Assessing the safety of medical treatments for children offers some unique challenges and difficulties. Although the research is in many ways similar to adult research, there are special considerations because of the differing physiology of children and the more stringent regulatory reviews that these studies require. This talk will highlight the important medical, ethical, and statistical issues that face researchers in this area. This talk will present several case studies of published research to encourage open discussion of these issues and exploration of the best approaches to meet the sometimes conflicting needs of regulators, drug companies, and ethics review boards.

Objectives:  In this class you will learn how to

• understand the medical differences in children that make pediatric research unique.
• be able to describe the controversies over informed consent and monetary compensation in pediatric studies.
• be able to identify the unique statistical challenges associated with pediatric research.

Teaching strategies:  Didactic lectures and small group exercises.

07/08/2008.