What Are Clinical Trials?

Clinical Trials are research studies that evaluate different types of treatment.

These treatments include:

New treatments; an addition to an established treatment; comparison of proven treatments to identify which is better.

PHASES

There are three Phases that most Studies will go through prior to becoming a standard Treatment (Studies must show acceptable results prior to moving to the next phase).

Phase I: A small group of patients are enrolled, and the study's main goal is to evaluate the risks and safety of new treatments.

Phase II: A little larger group of patients are enrolled, the study's main goal is to evaluate the risks, safety and effectiveness of new treatments.

Phase III: A large number of patients are enrolled, to prove the effectiveness of treatment, or to compare two different types of treatment.

Although there is a chance that the new treatment will be disappointing, the researchers involved in the study believe that it will be as good or better than currently available treatments.

OTHER TYPES OF STUDIES

Other types of studies include those that look at the impact of treatment on a patient:

• Quality of life issues
• Time involved
• Cost involved

REVIEW PROCESS

All studies are reviewed and approved by the University of Arizona Human Subjects Committee in order to minimize any risks possible to the patients, and to ensure patients are informed of the nature of the study in which they may participate.

Initiators of studies include physicians, support staff, pharmaceutical companies and equipment manufacturers.

Patients may be interested in enrolling in a trial because they hope that the treatment may help them more than what is customarily available, or they may simply want to contribute to the research effort.

PATIENT ELIGIBILITY AND ENROLLMENT

When patients are seen, they may be approached regarding a trial that may benefit them.

Patients must meet very strict eligibility criteria designed for each protocol.

Many patients will not be enrolled because they do not fit eligibility criteria.

Patients must have pre-study testing which may be more testing than required for standard treatment.

Patients must sign a study specific consent form prior to being enrolled in any study.

Patients in a study may have more follow-up requirements than patients treated conventionally -- some patients like this because they feel as if they are being watched more closely. 

Some of the studies we currently have available include drug therapy to either enhance the effectiveness of radiation, or to try to decrease the side effects of radiation therapy.

Research protocols are important because they are the only way to truly prove the effectiveness of treatments on closely matched patients, thus help us to improve our methods of treatment. We are also learning more and more how we can assist in the consequences of treatment in our patient's daily lives, attitudes, time and cost.