Clinical Trials

A clinical trial is a very highly regulated scientific experiment to test a medical hypothesis. A medical hypothesis might be expressed as a question (does this implanted pain pump work to relieve pain faster than taking pain medications the conventional way?) or it may be expressed as a statement to be tested (pain pumps are safe and effective for people suffering from chronic pain caused by diabetic neuropathy).

To test a hypothesis, scientists design a clinical trial or clinical study. The rules of the study are set forth in a “manual” or guide book called the study protocol.

You cannot participate in a clinical trial without knowing it. In order to enroll in a clinical trial, a healthcare professional must explain the study to you. This includes going over the hypothesis, explaining what is being tested, and possibly even describing how the study is set up. This healthcare professional must also tell you the possible risks you may subject yourself to and what could possibly happen. He or she will also tell you about the potential benefits and why the study is being conducted.

If you agree to participate in a clinical trial, you will be asked to sign some paperwork known as an “Informed Consent.” This basically means that you were given information about the study and at that point, consented to participate.

Not everyone who wants to participate in a clinical study is eligible. Clinical trials are run according to very strict guidelines. These guidelines include rules about who can enroll (“inclusion criteria”) and who cannot enroll (“exclusion criteria”). To qualify, you must meet all of the inclusion criteria and none of the exclusion criteria.

Your doctor can be your best source of information as to whether or not you might qualify to participate in upcoming clinical trials for pain management therapies.

Since there are potential risks associated with clinical trials, you may be wondering why anyone would participate. There are several reasons.

Nowadays, no new medical device or drug can be available to you without clinical testing.  For that reason, a clinical study gives you the chance to get a drug or device or other treatment that is not available to the general public. In other words, people in clinical trials may be getting the very latest in therapy.

Another reason some people decide to participate in a clinical trial is for the medical care. Most clinical trial protocols require frequent and very thorough examinations and tests. It is likely that the physicians, nurses and technicians who work with you are some of the very finest in their field in the world. For that reason, people in clinical trials benefit from getting a very excellent level of medical care.

Last but not least, participants in a clinical trial are playing a very significant role in advancing medical science. Without men and women willing to volunteer for these studies, we would not know what we do today about medicine.

Thus, it is important to thoroughly understand the risks and benefits associated with clinical trials.

A clinical trial is a major commitment. Trials last for a specific period of time and may require you to submit to multiple office visits, tests, exams, or other procedures. You will find out exactly what is expected of you when you sign your “Informed Consent.” It is important that you make a genuine commitment to follow through on your participation since study drop-outs can make it harder for investigators to reach scientifically sound conclusions.