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Because of progress made through clinical trials, many people treated for cancer are now living longer.
Allegheny General Hospital serves as the headquarters for the largest and longest continuously funded clinical trial organization in the country. For almost 50 years, this study group, known as the National Surgical Adjuvant Breast and Bowel Project (NSABP), has included thousands of breast cancer patients from many institutions around the world, and the studies it has conducted have changed the face of breast cancer therapy. Similarly, the NSABP conducts multi-institutional clinical trials in cancers of the colon and rectum that have led to improvements in patient outcomes from these diseases as well.
In addition to NSABP, we are proud participants in clinical trials sponsored by a number of other national cooperative cancer groups.
What are clinical trials?
Cancer clinical trials include research conducted in three different phases:
Phase I is designed to determine the safety of the product, or treatment. These trials typically involve a very limited number of participants and, the basic question being asked is: “Is it safe?”
Phase II is designed to determine if the drug or treatment is effective and to further evaluate safety. Relatively small numbers of participants are included, and the intent is principally to determine: “Does it work?”
Phase III is designed to further determine effectiveness and to compare it to the commonly used treatments. These studies usually include hundreds or thousands of participants and attempt to address: “Is it better?”
In phase I studies, small groups of research subjects, usually at a single institution, are treated and watched for side effects. The dose of the drug (or experimental treatment) is increased for each additional group of research subjects until the highest dose that can be safely given is identified.
In most phase II studies, there is a single treatment group and research subjects who meet specified requirements (eligibility criteria) may be registered to participate in the study.
Some phase II and all phase III studies involve at least two treatment groups. If the study is randomized, this means that researchers assign patients by chance either to a group getting the new treatment (called the treatment group) or to a group getting standard treatment (called the control group). Sometimes the treatment groups are made to look alike and neither the researcher nor the research subject knows which treatment they are receiving. In these cases, there is a statistician, a statistical center, or some other means of keeping track of which subjects receive which treatment.
What is a protocol?
Every clinical trial follows a written plan, called a protocol. The protocol specifies the type of research subjects that are included in the study, the treatment plan, and the goals of the study. For patient safety, each protocol must be approved by the Institutional Review Board (IRB) at each hospital or study site. This board includes scientists and doctors as well as non-scientists and people who work at the hospital along with representatives who do not work at the hospital. The IRB reviews the protocol to try to be sure that the research will not expose patients to extreme or unethical risks.
Clinical trials (protocols) may be conducted at a single institution (single site) or at multiple locations, either within the United States or internationally (multi-site). In addition, clinical studies may be supported, managed, and run (sponsored) by an individual physician or researcher, by a pharmaceutical company, or by a government agency such as the National Cancer Institute.
Can I be a participant in a clinical trial?
We encourage all cancer patients to consider participating in a clinical trial for which they may be eligible. Your nurse and/or cancer physician will be able to discuss these options with you. If you are interested, they will provide details of any trials that may be useful and will discuss specific study details so that you are fully aware of the purpose of the trial, the potential benefits and risks, and any costs for which you will be responsible that are not covered by your insurance.
It is through the generous dedication of thousands of patients over many years who have participated in cancer clinical trials that we have made the progress we have in conquering this complex disease, treating cancers of many different kinds and managing the side-effects of the treatments.
Clinical trials available at the West Penn Allegheny Health System. Please click here for more detailed information.