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Healthcare Today Technology and Procedures

Of Mice and Men: Clinical Trials and What You Should Know About Them

Introduction

The idea of experiments involving human beings may invoke memories of Nazi Germany’s brutal and sadistic experiments on concentration camp prisoners; or the infamous, decades-long Tuskegee “study in nature” of untreated syphilis among Macon County’s African-American citizens; or our government’s experiments studying the effects of radiation on unsuspecting citizens, to name only some of the notorious abuses of medicine.

Moreover, recent reports about gene-therapy clinical trials have not exactly been positive. There have been some unexplained deaths, and some questions about whether investigators reported these “adverse events” to the proper authorities.

Consequently, the whole concept of a clinical trial might give a person pause. Indeed, no one wants to be used as a human guinea pig, to be poked, prodded and medicated all in the name of science. Having said that, let me say to you that:
 

Clinical Trials May Present You With A Valuable Opportunity

Imagine yourself in any one of the following situations:

You have a serious illness. Your doctor has tried everything; nothing seems to work, and you’re getting worse. One day, she suggests you enroll in an experiment, a clinical trial in which investigators hope to prove that some drug yet to be approved by the FDA is effective in treating the very illness you have. You are being offered an opportunity to access a potentially beneficial treatment that would otherwise be unavailable to you.

But here’s the catch. If you enroll in the study, you have a fifty-fifty chance of receiving a placebo (a sugar pill), because the investigators need to have a control group in order to determine for sure whether the experimental drug is significantly more effective than a dummy pill. This can only be justified if there are no known alternative treatments for the given condition, or if the study has already tried all the alternative treatments and found them to be ineffective. In some studies, the control in not a placebo but an active drug; such experiments are intended to compare the efficacy of the experimental drug to that of the known therapy.

In such a study, known as a double-blind, placebo-controlled clinical trial, neither physician nor patient knows beforehand who is getting the study drug and who isn’t. Moreover, even if you are randomized to the study drug, there is no guarantee that the drug will help you; indeed, it could even make you worse.

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