Course Summary

New drug development requires major investment in capital, human resources and technical expertise. Strict adherence to regulations on testing and manufacturing standards is also required before a new drug can be marketed. One of the greatest challenges in conducting clinical trials is that of efficiency. As trials become more comprehensive, involving large numbers of participants globally, their duration is prolonged and costs increase. The longer trials last, the shorter is the patent life remaining after market approval and the longer patients must wait for the new product. This short course covers the key components of clinical trials and how these requirements interact with the drug development cycle.

Who will benefit from this module?

This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organisations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.

Learning Objectives

• Identify the key components of a clinical trial
• Outline the impact of clinical trial design on time and costs
• Describe the importance of clinical trial design
• Explain the roles of key members involved in clinical trials

Module Outline

Key topics covered in this module include:

• A brief description of the legislative framework for regulation of clinical trials
• The costs of drug development
• Patent life
• Clinical trial conduct
• The clinical development plan

Assessment - Multiple-choice assessment.