One of the options for treatment your oncologist may recommend is a clinical trial. Clinical trials are carefully designed research studies that answer specific questions regarding the effectiveness and safety of new drugs, combinations of drugs, treatments, surgical techniques, or medical devices. Human volunteers with specific health conditions are studied during the trials to determine the efficacy of the new approaches being tested on them. You may want to consider participating in a clinical trial. Often, trials offer access to promising new treatment options before they are generally available.

Some clinical trials are conducted in “controlled” conditions, meaning that one group of participants receives the therapy being tested and another does not. Later, health information from the two groups is compared to determine if the new therapy had any effect. A key process in such clinical trials is “randomization,” in which groups of patients are randomly chosen to receive one treatment or another, thus reducing the chance of bias in the findings.

Clinical trials are conducted by individual institutions (called investigator-initiated trials) or in cooperation with several institutions (called multi-institutional trials) depending on the type of clinical trial and the number of participants that will be enrolled. Clinical trials are organized in cooperation with pharmaceutical companies and with government research organizations such as the National Cancer Institute.

Should You Participate?
Clinical trials have been largely responsible for important advances in the treatment of kidney cancer in recent years. The key to their success is finding suitable human volunteers. By participating, you can obtain access to innovative treatments while helping advance researchers’ understanding of kidney cancer. Volunteers in clinical trials play an essential role in the ongoing quest to find a cure for the disease.

Clinical trials are highly regulated and monitored by the Food and Drug Administration. They cannot begin until rigorous intensive review has taken place, in order to ensure the scientific rationale is valid and that there is a fair balance of patient risk and benefit. Still, despite the careful regulation of clinical trials, you should be aware that there are potential drawbacks in addition to the potential benefits of clinical trial participation.

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