How to Understand How Clinical Trials Work if You Are a Patient - Part 1

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By Sarah Wilson CCRP
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Patient

Without human volunteers and clinical trials, the research community will have a very difficult time proving new therapeutic ideas and offering new treatments to the public. The warning labels on your medicine bottles and food products would not be possible if they had not been identified through clinical research and the generosity of clinical study patients. So, this 2-part article is for those patients who want to contribute but is afraid because of all the horror stories they have heard from the past. Some of those horror stories are true but times have changed and measures are in place to prevent re-occurrence. Read on and understand how clinical trials work and how important your contribution is to bringing new medicines and new medical treatment to those suffering from disease like cancer.

Difficulty: Moderately Easy

Instructions

Things You'll Need:

Desire to volunteer for a clinical trial

Step 1

Understanding the different clinical trial phases.

There are four phases of a clinical trial. You got it - Phase 1, Phase 2, Phase 3, and Phase 4. Phase 1 are for healthy people (typically college students do these because they have monetary value) and the object is to see how safe the investigational product is for humans to use. It has already proven safety in animals or it would not make it to human beings; but because the body systems are different, medical researchers must show the same safety in humans before giving it to sick people. The healthy clinical study patients are usually kept in a medical facility for a specified period of time to be observed and to have medical personnel immediately available if needed.

Phases 2, 3 and 4 are a lot like the Phase 1 clinical trial except they might have learned stuff that they can now tell you to look out for. They might have notice a lot of study patients reporting headaches, diarrhea, nausea, lightheadedness or something like that. We call these adverse events and you must tell the doctor so they will know to report it as a possible side effect of the experimental product. Phase 2 clinical study also check for effectiveness or whether or not the product works. At Phase 2, clinicians start with a smaller number of sick people to test the product on to see if they do as well as the healthy people did. Then in Phases 3 and 4; they increase the number of sick people to see how well the product works.
Step 2

You have rights – know them.

You have several rights while participating in a clinical trial. You have the right to know how many people are participating in the clinical trial and that you are not the only one. Your most important right of all is the "right to refuse". Even if it is your regular doctor (called primary care physician or PCP) telling you about the clinical trial, you have the right to just say "No". The doctor cannot punish you in any manner for refusing to participate in a clinical trial. Your level of care and treatment must remain the same. If you start the clinical study, you still have the right to quit or withdraw. Just tell them you don’t want to do it anymore. However, keep in mind that it was an experiment so go back for checkups as instructed and make sure you are alright and not experiencing side effects. Your rights are required to be described to you in writing in an informed consent form or informed consent document. (See more on informed consent in step 7).
Step 3

What is a “Placebo”?

If in a blinded clinical study (and many are), you could end up with a placebo or the active treatment (i.e. experimental product). A placebo is what we call a “sugar pill”. There is no medicine in it at all and it has no medicinal benefits. When I see people on a “sugar pill” saying they got numbness, lightheaded or some illness after taking it in a clinical study, it is probably what we call a “placebo effect” or “your mind playing tricks” on you.
Step 4

What is the difference between a clinical trial and a clinical study?

There is no difference between a clinical trial and a clinical study. They mean the same thing – some people just use different words.
Step 5

What is a protocol?

A protocol is a lot like a recipe. It tells the doctor what to do in order to get the information needed to prove to the FDA (Food and Drug Administration) that the investigational product works and should be given to people to help them.
Step 6

What are inclusion and exclusion criteria?

The inclusion and exclusion criteria or rules that tell the doctor who can and who cannot be accepted in the clinical trial. The clinical research coordinator, nurse, or doctor will ask you these questions to see if you qualify. If you do meet the rules of acceptance, you will be asked to sign an informed consent agreeing to participate.