Beacon is proud to be the only cancer center in the area to offer patients the opportunity to participate in clinical trials. Our affiliation with Mayo Clinic gives our patients access to some of the same cutting-edge clinical trials offered at Mayo Clinic, MD Anderson, John Hopkins, Memorial Sloan Kettering, the National Cancer Institute (NCI) and other large academic centers across the country.
What is a clinical trial?
Cancer clinical trials are research studies aimed at developing better ways to detect, treat and prevent cancer. Clinical trials are the final step in the process that begins with basic scientific research in a laboratory. Most of the treatments we use today are the result of past clinical trials. By taking part in a clinical trial you are among the first to receive new research treatments before they are widely available and are accepted as the standard of care. Your participation in a clinical trial will influence the future direction of cancer care. Any time you or a loved one needs treatment for cancer, clinical trials are an option to think about.
Clinical trials are not only for people who have advanced cancer that is not responding to treatment. Trials are available for all stages of cancer. Please ask your doctor about clinical trial opportunities.
Prior to participating in a clinical trial, you will go through the informed consent process. During this process, a research staff member will review the clinical trial with you so you can make an informed decision about participating in the trial. You will receive information on the reason for doing the trial, how many people are needed for the trial, any drugs that will be given and how often, the medical tests that will be done as part of the study, the risks and benefits of participating in the trial and other options available. You will also be given the opportunity to ask any questions prior to participating in a clinical study. If you decide to participate in a clinical trial you can stop participating at any time.
Types of Clinical Trials
Treatment Clinical Trials
Treatment clinical trials investigate new ways of treating your cancer to improve survival and minimize side effects. Such trials may incorporate new chemotherapy regimens, alternate approaches to radiation and/or novel surgical techniques.
Prevention Clinical Trials
Prevention trials investigate improved methods to prevent disease in people who have never had the disease or to prevent it from returning. These approaches can include medicines, vaccines, vitamins, minerals or lifestyle changes.
Screening Clinical Trials
Screening trials investigate improved ways of detecting cancers.
Quality of Life Clinical Trials
Quality of life trials explore ways to improve comfort and the quality of life for individuals with cancer.
Phases of Clinical Trials
Phase I study
Used to learn the “maximum tolerated dose” of a drug and to determine possible side effects.
Phase II study
Phase II studies involves a drug or treatment in which the dose and side effects are well known from a previous Phase I study. These studies are used to determine how well the drug or treatment works to treat a specific cancer.
Phase III study
A Phase III study compares a new drug or treatment against a commonly used drug or treatment. Some participants are given the new drug (or treatment) and some are given the commonly used the drug (or treatment). This phase of trial is designed to determine if the new drug or treatment is better at treating cancer than the “standard of care” drug or treatment.
Phase IV study
Phase IV clinical studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
Terminology Related to Clinical Trials
Arm is a term often used in clinical trials when patients are divided into groups. Each group or arm receives a specific treatment.
An open-label study is one in which both the patient and the doctor know what treatment the patient is receiving.
A blinded study is a study in which the patient, doctor or neither knows what treatment the patient is receiving.
Data Safety Monitoring Board
A Data Safety Monitoring Board is an independent group of people who review clinical trials to ensure they are safe for patients and provide recommendations to the study sponsor.
Institutional Review Board (IRB)
Institutional Review Board (IRB) is a group of people that review and approve the detailed plan for every clinical trial. IRBs are meant to protect the people who take part in a clinical trial. They check to see that the trial is well designed, legal and ethical. The IRB also reviews clinical trials to make sure they do not involve unnecessary risks and include a safety plan for patients.
An inactive substance or treatment that looks the same as — and is given the same way as — the active drug or treatment being tested in the clinical trial. Placebos are only used when there is no standard treatment or in a clinical trial that compares standard treatment plus a placebo with standard treatment plus a new treatment.
Phase III and some Phase II clinical trials use randomization – the method of selecting one of two or more treatment types by chance, not by choice, and is performed by a computer program. A participant is assigned to a treatment arm (see above) as determined by the computer program. The treatment in each arm is given with the highest level of professional care. The purpose of randomization is to make sure the composition (age, gender, stage, etc.) of the treatment arms are the same in order to produce accurate results. At the end of the trial, results of the studies are analyzed to determine if one treatment is better than another. The results may not be known for years after study completion.
For more information or to determine if an oncology clinical trial is right for you, please call the Beacon Cancer Research Department at 574-647-7370.