Be a Partner in Clinical Research

By Jane Farrell

Are you aware that you can participate in clinical research? Whether you’re healthy or sick, young or old, male or female, you’re probably eligible to participate in some type of clinical study. Maybe you or a loved one has an illness, and you’d like to help scientists find a treatment or cure. If you’re healthy, you can help researchers learn more about how the body works or how sickness can be prevented. Here, from the National Institutes of Health, is what you need to know:

Clinical research, also known as clinical studies or clinical trials, offers hope for many people, because it helps to find better treatments. Clinical trials are at the heart of all medical advances. And volunteer participants are essential to clinical trials.

Clinical research occurs at places such as hospitals, universities, doctors’ offices, and community clinics. Studies may be funded by foundations, medical institutions, pharmaceutical companies, and federal agencies such as NIH.

People with an illness or disease sometimes join a clinical trial to receive an experimental treatment or to have the additional medical care and attention offered by clinical trial staff. But many participants also say they volunteer to benefit others. “This will be my chance to give back and help other people, maybe even my family in the future,” said one NIH clinical trial volunteer who was battling cancer.

Our medical care is better today because of what clinical trials uncovered years ago. Dr. Lauren Wood, a physician-researcher at NIH, credits clinical trial volunteers for helping to transform AIDS from being a certain death sentence into a treatable, chronic (long-term) disease.

Many HIV-infected volunteers who received experimental AIDS drugs more than 2 decades ago went on to survive and thrive, and treatments given to pregnant mothers kept the virus from passing to their newborns. These antiretroviral drugs have since become standard therapy.

“I’ve seen these patients grow up, graduate from high school and college, launch their careers, and start families of their own,” Wood says. “They’re living their lives because of clinical research.”

A patient volunteer—someone with a known health problem—can help researchers better understand, diagnose, treat, or cure that disease or condition.

But healthy volunteers, who have no known major health problems, also play an important role in clinical research. They help researchers learn things that may indirectly help themselves and people they know. Healthy volunteers are usually paid for their efforts.

Both types of volunteers are needed, because researchers can learn more about a disease by comparing patient volunteers to healthy volunteers.

All clinical studies have guidelines about who can participate. Patient volunteers may be selected based on the type and stage of a disease, previous treatment history, and other medical conditions. The selection criteria help to ensure that researchers are studying the right people to help find answers to important medical questions.

Clinical researchers often look for people of different ethnicities, races, ages, and sexes. ”We want to have adequate representation from a variety of people, so we can make sure that we develop appropriate treatments,” Wood says. Some disorders affect certain groups of people more than others, so it’s especially important to have clinical research volunteers from the at-risk or affected population.

“We’ve found that certain racial or ethnic populations maymetabolizeor handle drugs in different ways. Sometimes drugs are metabolized differently based on age, sex or even ethnicity,” Wood says. Having a variety of volunteers allows researchers to determine the proper treatments and doses for different types of people.

If you’re thinking about participating in a clinical trial, members of the research team will talk with you about the details of the study; this is called informed consent. They’ll give you a document to sign that includes an overview of the study, such as its purpose, length, procedures, and who to contact for more information.

Members of the research team will also explain the risks and potential benefits of the study. “Volunteers should feel free to ask as many questions as they need to make things clear,” says Dr. Christine Grady, an expert in patient protection and bioethics at the NIH Clinical Center. “You can also take the informed consent form home and discuss it with your doctor or somebody else who can help you understand it better.”

If you decide to sign the informed consent form, you’re still free to withdraw from the study at any time, even after it begins. Informed consent is not a contract; its purpose is to make sure that you know enough about the study to decide whether or not to participate.

Clinical study participants are protected by a group of experts known as an Institutional Review Board (IRB). “Before the study even starts, clinical research involving humans is almost always reviewed by an IRB,” Grady says. “The IRB makes a judgment about whether or not the risks are acceptable and whether the benefits of doing the research justify the risks.”

A monitoring team usually also assesses study findings as a clinical trial proceeds. The team stays aware of any potential problems that may arise, and makes sure such issues are addressed.

After a study is completed, clinical researchers carefully examine the information they’ve collected. The results are often published in scientific journals. If the new approach proves to be safe and effective, it may become standard practice.

There are all kinds of clinical studies. Some evaluate new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. Others look at certain aspects of care, such as improving the quality of life for people with chronic illnesses.

“Participating in clinical research is essential to helping us get good care from our physicians,” Grady says.

We all benefit when people step up and volunteer to participate in clinical research studies. Talk with your health care provider about clinical trials and whether participation is right for you. To learn more about participating in clinical trials, including personal stories of research volunteers, visit NIH’s Clinical Research Trials and You website.