Clinical Trials Overview

What are clinical trials?

Clinical trials are studies, managed by government agencies, educational institutions, private not-for-profit organizations, or commercial businesses, to develop, produce, and evaluate the effectiveness of new treatments and therapies for diseases.

What are types of clinical trials?

According to the National Cancer Institute, there are different types of cancer clinical trials, including:

• prevention trials designed to keep cancer from developing in people who have not previously had cancer.

• prevention trials designed to prevent a new type of cancer from developing in people who have had cancer.

• early detection trials to find cancer, especially in its early stages.

• treatment trials to test new therapies in people who have cancer.

• quality of life studies to improve comfort and quality of life for people who have cancer.

• studies to evaluate ways of modifying cancer-causing behaviors, such as tobacco use.

What are the phases of a clinical trial?

• Phase I trials are the first studies to evaluate how a new drug should be administered (orally, intravenously, by injection), how often, and in what dosage.

• Phase II trials provide preliminary information about how well the new drug works, and generates more information about its safety and benefits. A Phase II study usually focuses on a particular type of cancer.

• Phase III trials compare a promising new drug, combination of drugs, or procedure with a current standard of treatment.

• Phase IV trials include the continuing evaluation that takes place after FDA (Food and Drug Administration) approval, when the drug is already on the market and available for general use (post-marketing surveillance).

What is a clinical trial protocol?

Clinical trial protocols are the action plans or guidelines that must be followed during the course of any study. Guidelines may cover:

• the design of the study - what it will study and how
  
  
• who may participate - criteria for patients who enter the study
  
  
• what medications and medical tests will be used to follow the participants
  
  
• what information is being searched for

Several research centers may be involved in the study, and each uses the same protocols to ensure that information from all centers can be combined and compared.

Where are trials conducted?

Large cancer centers, university hospitals, local medical centers, or physician offices, all may be included in managing clinical trials. There may be only one or two locations involved in a particular study, or hundreds around the country.

Who can participate in a trial?

Each protocol in a trial defines specific characteristics, called eligibility criteria, that participants should have in order to participate in the study. Characteristics may include type of disease and its stage, as well as the participant''s age and general health.

Eligibility criteria help assure that the study results answer the research question and identify who will benefit in the future from the approach being studied.

How are trial participants protected?

There several procedures in place, as part of the protocols, to protect the safety of the participants. Two groups that oversee the safety procedures are the:

• organization that sponsors the study, for example, the National Cancer Institute

• Institutional Review Board (IRB) that oversees clinical research in the healthcare institution. The IRB includes physicians, other healthcare providers, consumers, and sometimes members of the clergy, who do not have any personal interest in the results of the study. As neutral reviewers, they ensure that the study is conducted fairly and that there is not a high probability of harm to the participants.

Phase III trials also have a special group called a Data Safety and Monitoring Committee that looks at the test results, monitors the safety of the participants, and decides whether the study should go forward as originally planned.

For information on how to participate in a clinical trial, please talk with your physician.

Cancer Diagnosis and Treatment Programs at Rush University Medical Center in Chicago At Rush, we offer a range of standard and investigational therapies for the treatment of cancer. We have more than a dozen programs specializing in the treatment of specific cancers, including: Bone Cancer Brain Cancer Breast Cancer Colorectal Cancer Gynecological Cancers Head and Neck Cancers Hematological Malignancies (cancers of the blood and lymph system) Leukemia Lung Cancer Lymphoma Myeloma Orthopedic Cancers Prostate Cancer Radiation Oncology Skin Cancers/rumc/page-R11839.html Rush cancer programs are approved by the Commission on Cancer of the American College of Surgeons. Only one in four hospitals that treat cancer receive this special approval. Click here to visit the home page for Cancer Programs at Rush. Cancer Screening and Prevention Cancer screening and prevention are priorities at Rush. Through genetic testing, counseling and advanced techniques for early detection, Rush helps people with a strong history of breast, ovarian, colon and other cancers. And in our state-of-the-art mammography center, we have one of the city’s finest teams of radiologists dedicated to early detection of breast cancer. Breast Imaging Center Genetic Diagnosing and Counseling Center Inherited Susceptibility to Cancer Center Skin Cancer Detection Cancer Support Programs at Rush Cancer is not only a physical ordeal, it is also an emotional one, affecting cancer patients, their family and friends. To help address the whole person, we offer a number of resources to help patients and their loved ones cope in this difficult time. For information on the cancer support programs at Rush click here. Clinical Trials Rush offers a number of clinical trials of experimental cancer treatments. Use the links below to search for studies for a particular form of cancer. If you are interested in exploring your eligibility for one of our open trials, please call (312) 942-8312. If we do not list trials for a particular type of cancer, please feel free to call us to discuss other treatment options. For information on cancer clinical trial programs at Rush click here. Find a Specialist at Rush To find a cancer specialist at Rush, click on one of the following links: Oncology Gynecologic Oncology Orthopedic Oncology Pediatric Hematology-Oncology Radiation Oncology Surgical Oncology To find specialist at Rush in other cancer-related areas, click on one of the following links: Bone Marrow Transplant General Surgery Hematology Or make an appointment with a doctor at Rush by calling our toll-free physician referral number: (888) 352-RUSH. To reach the hospital operator, call (312) 942-5000. If you have difficulty hearing, call (312) 942-2207 (TTY/TTD).