Learning Objective

Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials.

Given the financial risk involved, it is crucially important that clinical trials be designed and set up efficiently to obtain adequate and accurate data in compliance with regulatory requirements.

This module aims to provide you with effective strategies for the preparation and conduct of a clinical trial, while adhering to regulatory safety standards. Management of data for submission is also covered.

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

• Outline the role of clinical trial design in clinical research.
• Identify the relevant legal documents and guidelines relating to clinical trial design.
• Recognise the essential statistical components for clinical trial design and how these affect design choice.
• Define the general principles and concepts for trial design, and describe the implications of design choice on regulatory acceptance.
• Identify the strategies to improve data capture and management.
• Describe how electronic data capture can improve clinical trial development.

Module Outline

Overview - This session briefly describes the relevant legal documents and guidelines relating to clinical trial design.

Clinical trials in drug development - The crucial role of clinical trials in the drug development cycle is examined. Regulatory requirements and financial pressures, and their interaction with trial design, are discussed.

Protocol design - This session provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.

Clinical trial preparation - This session provides an overview of the role of the sponsor in supporting and improving quality in the conduct of clinical trials.

Endpoints - This session focuses on clinical trial endpoints. The purpose of endpoints and the types are discussed in this part.

Statistical elements - This session covers the role of statistics in clinical trial design and analysis, as acknowledged in the International Council for Harmonisation (ICH) guideline for Good Clinical Practice (GCP).

Study design - This session provides an overview of the main types of study design.

Data capture and management - This session describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.

Assessment - Multiple-choice mastery assessment.