A Primer On Clinical Trials

A Primer On Clinical Trials

How to join one, and how to keep their purpose in perspective

Participating in a medical experiment isn’t for everything. Hopefully, you’ll never need to join one. Ut if you or a family member is sick with a life-threatening disease, a clinical trial program may be well worth considering. As experimental programs, the approaches being tested may not work and may even cause further medical problems. But agreeing to be a guinea pig for the latest medical technics or medications could also add many good years to your life.

Clinical trial research is generally federally funded and federally regulated, but conducted by private researchers at medical schools, drug companies, and hospitals, as well as by government scientists.

Research runs the disease gamut. To fight cancer, for instance, a new form of treatment, called biological therapy is being studied in clinical trials sponsored by the National Institutes of Health. This technique uses substances produced by the body’s own cells and substances that affect the body’s immune system to induce the body to fight the disease. In the AIDS area, one closely watched trial currently under way involves testing two experimental drugs to see if they can prevent the HIV virus from reproducing itself by interfering with the enzymes that reproduce the virus.

Other trials deal with chronic diseases that are not necessarily life-threatening. The NIH is currently conducting a clinical trial on herpes vaccines to determine if a person who is already infected with herpes can stave off further outbreaks by taking the vaccine. The vaccine is also being studied to see, if by taking it, a person who has been exposed to the virus can still be immunized.

Ideal candidates for clinical trial. Photo by Elena

Since the purpose of such trials is to answer a set of research questions, you have to fit the guidelines in order to be eligible. Be sure to discuss the suitability of a clinical trial with your personal physician, comparing the case for joining a trial with the arguments for following a more standard treatment. If you do decide to pursue an experimental program, be sure to ask:

•     What is the study’s scientific purpose?
•     What does the treatment involve?
•     Who will oversee your treatment?
•     What, if anything, will it cost you?
•     Does participation require relocation?
•     What type of follow-up care in involved?
•     How will the study’s results be used?

Participating in a trial means that you will probably be examined and tested more frequently than usual. If, during the study, it turns out that the trial is not in your best interest, you will be asked to drop out. If you decide not to continue, that, too, is fine.

The cost of trials varies from program to program. Virtually all NIH-sponsored experiments are free of charge to participants. Other clinical trials generally provide drugs for free, but in some cases patients may be charged for lab tests or doctor’s visits. Health insurance usually covers such expenses. In some cases, especially those involving an invasive procedure such as a spinal tap, patients may even receive minimal fees.