What is research?
Research is a carefully planned search for new information about health, diseases, medicine and treatments. Researchers use this information to see if new treatments are helpful, new tests can detect disease, or if new ways of caring for patients are successful. Research may also be called a “research study,” “medical research,” “clinical research study” or “clinical trial.”
Why is research needed?
Research is needed to improve health care and offer new solutions and hope for patients. Without it, physicians and scientists cannot develop new and improved diagnostic tools, medications, devices, or treatment protocols. In order for research to be successful, it must be done with the help of those most likely to benefit from it. In other words, research on a new drug, test or treatment must be done with the participation of people who have the kinds of illness or injury that the drug, test or treatment is being made for. Research studies with healthy people are also important. In some studies, researchers need to compare healthy volunteers with people who have a specific disease or condition.
What is a clinical trial?
A clinical trial, also known as a research study, is a carefully planned test. During clinical trials, researchers learn if a new test or treatment works and is safe. Treatments studied in clinical trials might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The purpose of a clinical trial may be to learn more about:
- New treatments
What are the different types of clinical research studies?
- Treatment studies test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention studies look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
- Diagnostic studies are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening studies test the best way to detect certain diseases or health conditions.
- Quality of Life studies explore ways to improve comfort and the quality of life for individuals with a chronic illness.
- Observational studies address health issues in large groups of people or populations in natural settings. In this type of study people are observed or certain outcomes are measured. No specific treatment is given by the researcher.
What are the phases of clinical trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of four phases:
- Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
- Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
- Phase III trials: The experimental study drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
- Phase IV trials: After a treatment has been approved and is being marketed, the drug’s maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.
Where do the ideas for clinical trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veterans’ Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria.” These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. Some studies look at healthy volunteers to learn how to keep people well, while others compare healthy volunteers with those who have specific illnesses.
Why participate in a clinical trial?
Research studies depend on volunteers who agree to be a part of them. By volunteering, you can further medical knowledge and potentially help others. You can also:
- Play an active role in your health care
- Get access to new research treatments before they are widely available
- Get expert medical care from study doctors at a top tier medical institution
- Help others by contributing to medical research
What should I consider before participating in a clinical trial?
Your participation in any clinical trial is voluntary. Before you volunteer to participate, you will receive an informed consent document that explains the details of the study, including its purpose, duration, required procedures, potential risks and benefits, as well as your rights and responsibilities.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. A member of the research team will discuss the study with you and answer your questions so you can make an informed decision about whether or not to participate. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
The informed consent document will help you make sure you know:
- It is your choice whether or not to take part
- Why the research is being done
- What will be done during the research and for how long
- What risks and/or side effects, if any, are involved
- What possible benefits you can expect
- What other options are available
- You have the right to leave the study at any time without interfering with your regular care
What are the risks of participating in a clinical trial?
All research is overseen by a panel of people, including some from our community, called an Institutional Review Board (IRB). The IRB’s primary concern is for the safety and well-being of the people who volunteer to participate in research. It is their job to decide whether the benefits of the research outweigh any concerns and to also track how the research is progressing. If you ever have a concern about research being done at UC Health, you can contact the IRB anonymously at 1-800-889-1547.
If you have any side effects or a reaction while participating in the research study, you will be given the appropriately needed care.
There are risks to clinical trials:
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. The IRB also ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Is there pay for participation?
Sometimes there is pay or compensation for the time and/or travel involved in the study.
What research studies are being conducted?
Researchers at UC Health are doing many different kinds of studies. Some studies test surgical techniques and new medicines, while some try to find out how to diagnose diseases more accurately and quickly. Other research studies look at improving how we practice medicine, deliver health care and prevent illness and injury. Find a study