Table of Contents

Chapter 10: Participating in Clinical Trials

The process of moving a new cancer therapy from the lab to the clinic can be long and difficult, and for every therapy that makes it through, there are many, many more that don’t. What holds things up? Why is it so difficult to get good, effective therapies into the hands of people who need them?

The United States Food and Drug Administration (FDA) is tasked with ensuring that all of the drugs that we use—from Tylenol to Taxotere—are as safe and effective as possible. No two people react to a medication in exactly the same way, so there’s no way to guarantee that it won’t harm someone unexpectedly. And there’s no substance on Earth that won’t cause some sort of side effect if given to someone who can’t tolerate it. Recognizing all of that, the FDA has set up a system that is designed to sift out the better drugs from the worse ones, and to try to make the better ones as safe and effective as possible.

The job of the FDA is to get new therapies into the hands of doctors so they can, in turn, get them into the hands of people who need them. Clinical trials are the process by which researchers and the FDA evaluate experimental new therapies, and then determine who will benefit most from them.

In this Chapter, we’ll look at the way that clinical trials are used to evaluate the safety and efficacy of a new cancer therapy, and discuss whether participation in a clinical trial might be a good choice for you.

Keep in mind that the process described here might be somewhat different for therapies being developed for other types of diseases, and non-drug treatments or devices will have their own set of rules and regulations. But regardless of exactly which steps a new drug or device will undergo, the goal is the same: to make sure that they’re as safe and effective as possible.