Chapter 5
Conducting Clinical Research
In This Chapter
Planning and carrying out a clinical research study
Protecting the subjects
Collecting, validating, and analyzing research data
This chapter and the next one provide a closer look at a special kind of biological research — the clinical trial. This chapter describes some aspects of conducting clinical research; Chapter 6 gives you the “big picture” of pharmaceutical drug trials — an example of a high-profile, high-stakes, highly regulated research endeavor. Although you may never be involved in something as massive as a drug trial, the principles are just as relevant, even if you’re only trying to show whether drinking a fruit smoothie every day gives you more energy.
Designing a Clinical Study
Clinical studies 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 you should keep in mind at the start of any research project.
Identifying aims, objectives, hypotheses, and variables
The aims or goals of a study are short general statements (often just one statement) of the overall purpose of the trial. For example, ...
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