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Clinical research is research in which people, or data, or samples of tissue from people, are studied to understand health and disease. Clinical research helps find new and better ways to detect, diagnose, test, and prevent disease.

Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research.

Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.

Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.

Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition.

Screening Research aims to find the best ways to detect certain disorders or health conditions.

Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness.

Genetic studies aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient’s genetic make-up.

Epidemiological studies seek to identify the patterns, causes, and control of disorders in groups of people.

An important note: some clinical research is “outpatient,” meaning that participants do not stay overnight at the hospital. Some is “inpatient,” meaning that participants will need to stay for at least one night in the hospital or research center. Be sure to ask the researchers what their study requires.

Clinical trials at the UW–Madison and UW Health are medical research studies that test the effects of a drug, medical device or other medical treatment on a group of human volunteers. There are many clinical trials underway at  UW–Madison and UW Health, ranging from cancer, Alzheimer’s, diabetes, and heart disease to smoking cessation.

Clinical Trial Phases

A medicine or treatment must go through three phases before it is approved for use by the FDA. A fourth phase happens after the medicine or treatment has been approved.

Phase I
A new medicine is tested for the first time on a small group of healthy people or people with certain conditions or diseases. Researchers check the safety of the medicine or treatment, the best dose or schedule to use, and what types of side effects occur. During this phase, all the people involved in the study (patients, doctors, and researchers) know what medicine is being used. These are called nonrandomized, nonblinded studies.

Phase II
The medicine or treatment is tested on a larger group of people with certain conditions or diseases. This phase helps researchers find out how well a medicine or treatment will work to treat a particular problem. Phase II trials are also usually nonrandomized, nonblinded studies.

Phase III
The medicine or treatment is tested on even larger groups. The medicine is studied to find out how well it works compared with standard treatment or placebo. Researchers also study whether the medicine improves specific areas in your life, such as how well you are able to keep your usual routine. Most medicines that reach this phase will be considered for FDA approval. During phase III trials, participants receive the study medicine, a placebo, or the standard treatment. Neither the participants, the doctors, nor the researchers know which person is getting which medicine. These are called randomized and double-blinded studies.

Phase IV
Medicines are also studied after they are approved. These studies can find new uses for the medicine, different ways to give it, or more safety information. For example, a medicine may be studied to see how well it works for a certain population, such as adults over the age of 65 or a certain racial group.

New combinations of approved medicines can be studied in phase II, phase III, or phase IV trials.

After a clinical trial is finished

After a clinical trial is completed and the results are studied, the FDA decides whether to approve continued development of the medicine. If the medicine that you received remains in development, you may be able to get more doses as an extension of the study.

If the results of the clinical trial show that the new medicine or combination of medicines works much better than standard treatment, the new medicine may become available to the general public.

Your treatment team may continue to check on you after your trial is over.

ClinicalTrials.gov is an online clinical study registry and results database for participants, their families, health-care professionals, researchers, policy makers, and the public to access information about research studies involving human volunteers.

StudyFinder – Search for open clinical trials at UW Health and the University of Wisconsin–Madison.

ClinicalTrials.gov – Search for open clinical trials around the world.

Your doctor will help you find out if you are eligible to take part in a clinical trial. The company sponsoring the trial will have a very strict set of standards, or criteria, that all participants must meet.

If you meet the criteria, you may be “randomized” to get either the new medicine that is considered standard therapy, or a placebo. “Randomized” means that a computer is used to randomly assign you to one of the treatments. In many studies, neither you nor your doctor knows which treatment you are getting. But not all clinical trials randomize people. And if you have a serious disease, such as cancer, you will not be given only a placebo, unless no effective treatment is known.

After you are accepted into the clinical trial and give your consent to take part:

• You will be given a structured program to follow
• You will have a schedule of tests, doctor appointments, and treatments
• You may be asked to keep a diary of your experience during this time

Doctors, nurses, social workers, and other health professionals may be part of your treatment team.

Be sure to carefully follow instructions. If you don’t know what you are supposed to do next, call your doctor or the person responsible for your trial. Please keep in mind that your participation is voluntary, and you can withdraw at any time.

“Informed” means you are made aware of the possible risks and benefits of participating in a clinical trial and “consent” means that you have given permission to proceed with participation in the trial.

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. To help you decide whether or not to participate, the study team will explain the details of the trial. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. You will, then, decide whether or not to sign the document. Please note that a signed informed consent document is not a contract, and you can stop participating in the trial at any time.

If you decide to participate, we encourage you to ask questions and have discussions with your study team, throughout the process, so you have all of the information you need to confidently participate in a clinical trial.

Clinical trials are important because they allow researchers to find out if a new drug or treatment works as well as or better than current options. The new drug or treatment might have fewer or less serious side effects. The new drug or treatment also might not work as well or might cause more side effects than standard treatments.

Clinical trials help drug companies make medicines that are safer and more effective with fewer side effects. Clinical trials also help these companies decide whether it is worthwhile to seek approval from the U.S. Food and Drug Administration (FDA) for a certain medicine. If a medicine doesn’t work as well as standard treatment, then the FDA isn’t likely to approve it.

Clinical trials are also important in finding treatments if no standard treatment exists.

Taking part in a clinical trial may not benefit you directly. But in the future it may help other people who have the same disease.

Clinical trials must follow strict federal rules and regulations to protect the safety of trial participants. There are risks to participating in clinical trials, including extra tests or procedures, unexpected side effects, and the possibility that the new treatment my not be better than, or even as good as, the standard treatment. The research team will discuss all known risks with you before you enroll in a clinical trial.

Participating in a clinical trial is completely voluntary and you can stop participating at any time, for any reason. But please be sure that you will still receive the best care at UW no matter what you choose.

Did you know that all drugs and devices have to go through clinical trials first? Think about all of the medications, vaccines, and medical devices on the market. That is a lot of clinical trials!

Clinical trial participants should represent the types of patients who will use the medication, vaccine, or device, but this hasn’t always been the case. In fact, 80% of trial participants are white and only 45% are women. We need to fully understand how a medication, vaccine, or device will affect a range of individuals, so our ability to provide better healthcare to everyone improves with more diverse participation in our clinical trials.

Learn more about why diversity matters for clinical trials …

During the informed consent process, the research team will clearly outline any payment that will be provided. It’s also important for you to ask the research team about payment for expenses or indirect costs of participating in a trial, such as time away from work, travel to and from the research site, child care coverage during study appointments, etc.

In many cases, the drugs or treatments being studied in a trial are provided at no cost to you. However, there might be other expenses. We suggest talking with your doctor before contacting your insurance. If your doctor thinks you qualify for a clinical trial, the study team can provide more information and assist with your insurance provider.

The length of the clinical trial varies, depending on what is being studied. You will be told how long the trial will last before you enroll.