Narrator: This presentation is a brief introduction to terms, purposes, benefits, and risks of clinical research.
If you have questions about the content of this program, talk with your health care provider.
Clinical research is a process to find new and better ways to understand, detect, control and treat health conditions. The scientific method is used to find answers to difficult health-related questions.
There are many ways to participate in clinical research at the Mayo Clinic. Three common ways are by volunteering to be in a study, by giving permission to have your medical record reviewed for research purposes, and by allowing your blood or tissue samples to be studied.
There are many types of clinical research.
- Prevention studies look at ways to stop diseases from occurring or from re-occurring after successful treatment.
- Screening studies compare detection methods for common conditions.
- Diagnostic studies test methods for early identification of disease in those with symptoms.
- Treatment studies test new combinations of drugs and new approaches to surgery, radiation therapy, and complementary medicine.
- The role of inheritance or genetic studies may be independent or part of other research.
- Quality of life studies explore ways to manage symptoms of chronic illness or side effects of treatment.
- Medical record studies review information from large groups of people.
Participants in clinical research volunteer to take part. Participants may be healthy, at high risk for developing a disease, or already diagnosed with a disease or illness. When a study is offered, individuals may choose whether or not to participate. If they choose to participate, they may leave the study at any time.
You will hear many terms describing clinical research. These include research study, experiment, medical research, and clinical trial.
A clinical trial is research to answer specific questions about new therapies or new ways of using known treatments. Clinical trials take place in phases. For a treatment to become standard, it usually goes through two or three clinical trial phases. The early phases look at treatment safety. Later phases continue to look at safety and also determine the effectiveness of the treatment.
A small number of people participate in a Phase I clinical trial. The goals are to determine safe dosages and methods of treatment delivery. This may be the first time the drug or intervention is used with people.
Phase II clinical trials have more participants. The goals are to evaluate effectiveness of the treatment and to monitor side effects. Side effects are monitored in all the phases, but this is a special focus of Phase II.
Phase III clinical trials have the largest number of participants and may take place in multiple health care centers. The goal of a Phase III clinical trial is to compare the new treatment to the standard treatment. Sometimes the standard treatment is no treatment.
A Phase IV clinical trial may be conducted after U.S. Food and Drug Administration approval. The goal is to further assess the long-term safety and effectiveness of a therapy. Smaller numbers of participants may be enrolled if the disease is rare. Larger numbers will be enrolled for common diseases such as diabetes or heart disease.
Mayo Clinic funds clinical research at facilities in Rochester, Jacksonville, Arizona, and the Mayo Health System. Clinical research is conducted in partnership with other medical centers throughout the world. Other sponsors of research at Mayo Clinic include the National Institutes of Health, device or pharmaceutical companies, foundations, and organizations.
Dr. Hugh Smith, former Chair of Mayo Clinic Board of Governors stated Our commitment to research is based on our knowledge that medicine must be constantly moving forward, that we need to continue our efforts to better understand disease and bring the latest medical knowledge to our practice and to our patients.
This fits with the term “translational research” meaning what is learned in the laboratory goes quickly to the patient’s bedside and what is learned at the bedside is taken back to the laboratory.
All clinical research conducted at Mayo Clinic is reviewed and approved by Mayo’s Institutional Review Board. Multiple specialized committees and colleagues may also provide review of the research. Federal rules help ensure that clinical research is conducted in a safe and ethical manner.
An Institutional Review Board reviews all clinical research proposals. The goal is to protect the welfare and safety of human subjects. The IRB continues its review as research is conducted.
Participants sign a consent form to assure that they understand key facts about a study. Such facts include that participation is voluntary and they may withdraw at any time. The consent form is an informational document, not a contract.
Staff from the study team describe the research activities during the consent process. The research may include X-rays, blood tests, counseling or medications.
During the consent process, you may hear different phrases related to study design. Randomized means you will be assigned to a group by chance, much like a flip of a coin. In a single-blinded study, participants do not know which treatment they are receiving. In a double-blinded study, neither the participant nor the research team knows which treatment is being administered.
Some studies use an inactive substance called a placebo.
Multi-site studies allow individuals from many different locations or health care centers to participate.
If the consent form states remuneration is provided, you will be paid for your time and participation in the study.
Some studies may involve additional cost. To address costs in a study, carefully review the consent form and discuss questions with the research team and your insurance company. Medicare may cover routine care costs that are part of clinical trials. Medicaid programs in some states may also provide routine care cost coverage, as well.
When considering participation in a research study, carefully look at the benefits and risks. Benefits may include earlier access to new clinical approaches and regular attention from a research team. Research participation often helps others in the future.
Risks may include side effects. The research treatment may be no better than the standard treatment and may cause more side effects. More visits, if required in the study, may be inconvenient.
Consider your situation as you weigh the risks and benefits of participation prior to enrolling and during the study. You may stop participation in the study at any time.
Stay informed while participating in research:
- Write down questions you want answered.
- If you do not understand, say so.
- If you have concerns, speak up.
Website resources are available. The first website lists clinical research at Mayo Clinic. The second website, provided by National Institutes of Health, lists studies occurring in the United States and throughout the world.
Additional information about clinical research may be found at the Mayo Clinic Barbara Woodward Lips Patient Education Center and the Stephen and Barbara Slaggie Family Cancer Education Center.