Introduction

Overview

The Overview Section of the Protocol provides a snapshot of the protocol's content. The Overview will outline what products are being tested, the scheme, or design of the study (e.g., the number of participants assigned to the different groups that will receive an experimental product or combination of products), as well as the study sponsor, protocol leadership, and clinical sites.

Prior to delving into the components of the Roche Protocol, we will offer a short introduction to clinical trial design and ethical considerations governing the conduct of studies involving human subjects. A more detailed description is given in the basic course of clinical research.

If you have already studied this course, we suggest that you go directly to the Points to Consider of Clinical trial basics and Etical considerations sections. For those who are not cancer specialists, the Product basics section will provide a useful reminder of cancer therapy and anti-colon cancer drugs in particular.

Learning Objectives

After reviewing the Basic Concepts and Protocol Overview Section, learners should be able to:

• Describe the essential elements of a clinical trial which include defining the hypothesis(es), selecting the subjects, specifying the intervention, and measuring the relevant outcomes of the study

• Understand the role of randomization and blinding to reduce bias in clinical trials

• Outline the major players involved in conducting multi-site clinical trials

• Discuss ethical and regulatory guidance governing clinical trial conduct

• Summarize the need for and challenges in developing a new anti-cancer drug