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Clinical Trials

When I was at NIH in 1987, I participated in a Clinical Trial. Here's more about what a clinical trial entails.

A clinical trial is an organized study conducted in order to answer specific questions about a new treatment or a new way of using a known treatment. Each study tries to increase medical knowledge and to find new and better ways to help patients. Besides studying new drugs, clinical trials study new combinations of drugs already used, new ways of giving treatment, and how changes in lifestyle can help patients. Other clinical trials compare the best known standard therapy with a newer therapy to see if one produces more cures and causes fewer side effects than the other.

Most clinical trials are carried out in steps called phases. Each phase is designed to find different information. Patients may be eligible for studies in different phases, depending on their general condition, the type and stage of their disorder, and what therapy, if any, they have already had. Patients are seen regularly to determine the effect of the treatment, and treatment is always stopped if side effects become too severe.

With information about ongoing and upcoming clinical trials around the world and all the latest news on medical advances, this section promises to be yet another important source of information for pituitary patients.

From Rare/Orphan Diseases

Many Patients Unaware of Clinical Trials

Many clinical studies to test new methods of treating illnesses can't get enough volunteers to participate, say recent studies and polls. The American Society for Clinical Oncology surveyed 6,000 cancer patients in a poll and found 84% of them either didn't know about clinical studies or didn't think studies were an option for them. The poll found that only 4% of the patients surveyed had participated in a study.

The New England Journal of Medicine published a study comparing elderly cancer patients enrolled in clinical studies to those not in studies. The article reported that although 63% of people with cancer in the U.S. are age 65 or older, elderly cancer patients make up only 25% of patients in cancer studies. In breast cancer studies the disparity was even greater: the elderly make up 49% of patients but only 9% of study subjects.

There may be several reasons why patients aren't participating in clinical studies. One reason may be that since the majority of people who do participate in studies learn about them from their physicians, perhaps doctors themselves are unaware of clinical studies, or the doctors may be deciding ahead of time that some patients won't be eligible for certain studies, and thus don't talk to those patients about study participation.

Another reason for low participation may be patients' concerns about insurance coverage for the doctor visits, tests, and medicines required for clinical studies. In June, President Clinton announced that Medicare will now reimburse the routine patient care costs of clinical trials to test new therapies. This should help increase the numbers of elderly patients involved in clinical trials. Other insurance plans already often cover study costs. In the survey of cancer patients mentioned earlier, of those who had participated in clinical studies, 86% had secured insurance coverage.

Other misconceptions that patients have about clinical studies are that they won't get the best treatment if they participate, or they will get a placebo (sugar pill) and be treated like a guinea pig. Besides the fact that clinical studies are subject to very strict rules and guidelines, and are evaluated very carefully before they are even started, participants in studies are fully informed about everything in the study before they make any decision to participate. In that same survey of cancer patients participating in studies, 97% said that they received excellent or good quality care, were treated with dignity, and would recommend participation to others.

The National Institutes of Health provides complete information about what clinical trials are, what you should know about participation, and what questions to ask if you're considering enrolling in a study.

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