What you Need to Know About Clinical Trials

• Clinical trials are research studies that involve people and test new ways to prevent, detect, diagnose, or treat cancer and other diseases.  People who take part in cancer clinical trials have an opportunity to contribute to scientists knowledge about cancer and to help in the development of improved cancer treatments.  They also receive state-of-the-art care from cancer experts.

• Every clinical trial has a protocol that describes what will be done in the trial, how the trial will be conducted, and why each part of the trial is necessary.  The protocol also includes guidelines for who can and cannot participate in the trial.  Enrolling people who have similar characteristics helps ensure that the outcome of a trial is due to the intervention being tested and not to other factors.  In this way, eligibility criteria help researchers obtain the most accurate and meaningful results possible.

• National and international regulations and policies have been developed to protect the rights, safety, and well-being of people who take part in clinical trials and to ensure that trials are conducted according to strict scientific and ethical principles.  Clinical trials must be reviewed and approved by an Institutional Review Board (IRB).  The IRB reviews all aspects of a clinical trial to make sure that the rights, safety, and well-being of trial participants will be protected.

• Informed consent is a process through which people learn the important facts about a clinical trial to help them decide whether or not to take part in it, or whether to continue participating in it.  Anyone can choose to leave a trial at any time either before it starts or at any time during the trial or during the follow-up period.

• Many states require that insurance companies cover the costs of routine care for people taking part in a clinical trial.  In other states, voluntary agreements between the states and insurance companies include such a provision.  However, coverage varies by state, by health insurance plan, and by type of clinical trial.

• People interested in taking part in a clinical trial should talk with their health care provider

Information from the National Cancer Institute:  http://www.cancer.gov