Let's Talk About Clinical Research
Narrator: This presentation is a brief introduction to the terms, purposes, benefits and risks of clinical research.
If you have questions about the content of this program, talk with your health care provider.
What is clinical research?
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.
Ways to participate
There are many ways to participate in clinical research at 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.
Types of clinical research
There are many types of clinical research:
- Prevention studies look at ways to stop diseases from occurring or from recurring 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 records studies review information from large groups of people.
Clinical research volunteers
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.
Research terms
You will hear many terms describing clinical research. These include research study, experiment, medical research and clinical trial.
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.
Phase I clinical trial
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 trial
Phase II clinical trials have more participants. The goals are to evaluate the 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 trial
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.
Phase IV clinical trial
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.
Clinical research sponsors
Mayo Clinic funds clinical research at facilities in Rochester, Minnesota; Jacksonville, Florida; and Arizona, and in the Mayo Clinic 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.
Clinical research at Mayo Clinic
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.
Ethics and safety of clinical research
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.
Institutional review board
An institutional review board (IRB) 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.
Consent process
Participants sign a consent form to ensure 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.
Study activities
Staff from the study team describe the research activities during the consent process. The research may include X-rays, blood tests, counseling or medications.
Study design
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.
Multisite studies allow individuals from many different locations or health care centers to participate.
Remuneration
If the consent form states remuneration is provided, you will be paid for your time and participation in the study.
Costs
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.
Benefits
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/inconveniences
Risks may include side effects. The research treatment may be no better than the standard treatment. More visits, if required in the study, may be inconvenient.
Weigh your risks and benefits
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.
Ask questions
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.
Websites
Website resources are available. The first website lists clinical research at Mayo Clinic. The second website, provided by the 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.