What are clinical trials?

Clinical trials are carefully designed studies that help us to learn more about the diseases that we treatand to examine the effectiveness of different types of treatment. In some cases, the effects of new drug therapies are compared to other types of existing therapy for a given disease. Other trials may involve studying the effects of various types of surgical intervention. Many of the trials in which we participate are funded by the National Institutes of Health, whereas, others are funded by pharmaceutical companies.

Why should I participate in clinical research?

The primary goal of clinical research is to advance our understanding of the diagnosis and treatment of various diseases. This may not only be of benefit to you but is important for others and future generations that may be affected by the same problem. Other benefits may include access to potentially beneficial treatments before they are approved for routine use. As a participant in a clinical trial, you are typically followed more closely than non participating patients. This extra level of attention may be an added benefit.

Is there any risk associated with participation in clinical trials?

Some clinical trials involve already established treatments with well-defined risks. Participation in such studies may pose no additional risk. Other studies may involve novel types of therapy where the associated risks may be largely, but not entirely, predictable. All clinical trials have what is known as an independent data and safety monitoring committee. The is a group of medical professionals independent from the investigator and pharmaceutical or medical device company, that regularly reviews the study data. If there are any trends that suggest there may be harm to patients, it is required that the data safety monitoring committee notifies the other parties so that the study can be terminated if necessary. This rarely happens. It is, however, comforting to know that all clinical research is monitored in this fashion in order to protect your safety.

Does it cost me anything to participate in clinical trials?

There is no cost to you for participating in clinical research. Typically, all expenses related to the study such as treatments, office visits, medications, etc. are covered by the study sponsor. In some studies, there may be compensation available for your time and effort contributed to the study. In some casesparticipation in a clinical trial can maketreatment available that otherwise might not be affordable.