CHAPTER 5 Conducting Clinical Research 61

Chapter 5

Conducting Clinical

Research

T

his chapter provides a closer look at a special kind of human research —

the clinical trial. The purpose of a clinical trial is to test one or more

interventions, such as a medication or other product or action thought to be

therapeutic (such as drinking green tea or exercising). One of the important fea-

tures of a clinical trial is that it is an experimental study design, meaning that

participants in the study are assigned by the study staff which intervention to

take. Therefore, there are serious ethical considerations around clinical trials. On

the other hand, the clinical trial study design provides the highest quality

evidence you can obtain to determine whether or not an intervention actually

works, which is a form of causal inference. In this chapter, we cover approaches

to designing and executing a high-quality clinical trial and explain the ethical

considerations that go along with this.

Designing a Clinical Trial

Clinical trials should conform to the highest standards of scientific rigor, and that

starts with the design of the study. The following sections note some aspects of

good experimental design.

IN THIS CHAPTER»

» ^{Planning and carrying out an}

experimental clinical trial study»

» ^{Protecting the participants»}

» ^{Collecting, validating, and analyzing}

research data