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Who’s Your Inspiration?

We’ve all been impacted by illness. Whether experienced personally or through the health challenges of a loved one, we all, unfortunately, know the hardships illness can bring to our families and communities. Participation in clinical research is one way to directly combat illnesses that have affected our loved ones and/or ourselves. Whether inspired to explore participating in a clinical trial by a personal journey, or the health journey of a friend or family member, our team is here to welcome you, answer your questions, and provide as much information as possible to support you with an informed decision.

 

Did you know that every single effective drug or medical device or procedure is the result of a successful clinical trial? By engaging in clinical research at UW, participants have an opportunity to actively contribute to the development of, potentially, lifesaving research in the fight against a range of illnesses including cancer, diabetes, heart disease, Alzheimer’s, COVID-19, and more. Researchers at the University of Wisconsin–Madison and UW Health are working every day to discover breakthroughs in the prevention, detection, and treatment of disease, and there are plenty of opportunities to actively participate, as partners, in this research by learning more about and/or enrolling in clinical trials.

 

Diversity of participants in clinical trials is incredibly important to ensure that drugs and medical treatments and devices are safe and effective for a range of individuals. So, whether healthy or battling an illness, people of every age, race, color, gender, and sexual orientation, of all shapes, sizes, and abilities, and from all walks of life, are needed. Together with researchers we can move toward a healthier future for generations to come. Research participants are partners in this critical effort to improve the health of all individuals, families, and communities in Wisconsin. Learn more about how you can get involved!

 

5 things you should know about clinical trials*

 

      1. Clinical trials are research studies conducted with people – They are designed to answer specific research questions about medical products or therapies.
      2. Participation is always voluntary – You can leave a study whenever you want.
      3. Clinical trials often need healthy volunteers to help answer research questions.
      4. Your safety is a priority – Researchers must follow detailed protocols and safety requirements to make each trial as safe as possible.
      5. The study will be explained to you in an informed consent process (see below) before you agree to join.

 

* Source: US Food and Drug Administration (FDA)

Frequently Asked Questions

What is clinical research?

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.

What is a clinical trial?

Clinical trials at the UW–Madison School of Medicine and Public Health 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.

What is ClinicalTrials.gov?

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.

What clinical trials are available?

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.

How do clinical trials work?

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. That 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.

What is informed consent?

“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 someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. 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. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

 

We encourage our participants to ask questions and have discussions with their study team, throughout the process, so they have all of the information they need to confidently participate in a clinical trial.

Why are clinical trials important?

Clinical trials are important because they compare new treatments with accepted treatments. They allow researchers to find out if a new treatment works as well as or better than accepted treatments. The new treatment might have fewer or less serious side effects. The new 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. [https://patient.uwhealth.org/healthwise/article/tv7019]

Are clinical trials safe?

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. You will still receive the best care from UW no matter what you choose.

Why is diversity important for clinical trials?

Clinical trials, and the people who volunteer to participate in them, are essential to help the development of ways to fight illnesses.

 

Participants enrolled in a trial should be representative of the types of patients who are likely to use the medical product if it is approved.

 

Certain populations can be more at risk for certain diseases—such as diabetes and heart disease—than others. So it is important for patients in those populations who are more likely to be treated for a condition to be included in a trial. And, unfortunately, participants in clinical trials are primarily white/caucasian. For instance, a 2021 study found that, in the United States, cancer-focused clinical trials participants were 84% White/Caucasian; 7% Black/African-American; 3% Asian; and 3% Hispanic/Latino.

 

Experience has shown that there can be important differences in how people of diverse groups respond to medical products, so it is imperative that clinical trials participation accurately represents the US population. Information on those differences can then be included in the product labeling to help doctors and patients make treatment decisions.

 

The bottom line? Researchers should test medical products in all groups of people to help ensure medical products are safe and effective in everyone who will use them. That’s why diversity in clinical trials is essential.

 

Learn more about why diversity matters for clinical trials …

Will I be paid for participating in a clinical trial?

Payment varies from trial to trial. In general, patients are not paid for participating, but expenses may be covered. However, there are times when payments may be made for participating, particularly for Phase I trials. The research team will clearly outline any payment that will be provided during the informed consent process. It is also important for a potential clinical trial participant 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.

What costs are involved?

In many cases, the costs of drugs being studied in clinical trials are provided at no cost to you. However, there might be other expenses. We suggest talking with your doctor before contacting your health plan. If a doctor determines you qualify for a clinical trial, a clinical research coordinator can provide more information and assist with your insurance provider.

How long do clinical trials last?

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

Elderly couple searches for medical information on a smartphone.

Search the numerous ongoing UW–Madison and UW Health clinical research efforts seeking participants.

Questions?