Gene Gary-Williams began participating in a clinical research study in 1996. Why? “African-American people in general have not been involved in many of the medical studies,” she explains. “For a long time, we weren’t invited and then, when the opportunity presented itself, we were too suspicious.... As women of color, we need to participate so that we can provide information researchers would not be able to get otherwise.”
Are you playing your part in clinical research? Doctors and scientists are conducting clinical studies in every state of the union. They’re looking for volunteers of all ages, from all cultures, with different lifestyles. You may be able to help them learn how to improve the health of hundreds, thousands or millions of people.
In clinical research—also known as clinical trials or clinical studies—volunteers participate in carefully conducted investigations designed to uncover better ways to treat, prevent, diagnose and understand human disease. The studies can be sponsored by foundations, medical institutions, pharmaceutical companies and federal agencies such as NIH. Sites as varied as hospitals, universities, doctors’ offices or community clinics can host trials.
The idea for a study often begins in a laboratory, hospital or clinic. Researchers first develop new therapies or procedures in the laboratory and then test them in animal studies. The treatments that prove most promising move into
Two types of volunteers are needed for clinical research. A healthy volunteer is a person with no known significant health problems. Healthy volunteers don’t directly benefit from their participation, but they help researchers develop new knowledge that may indirectly help them and people they know. Healthy volunteers might be needed for several reasons. For example, when developing a new technique, such as a blood test or imaging device, healthy volunteers help define the limits of what is considered normal.
The other type of volunteer, a patient volunteer, has a known health problem and is needed to better understand, diagnose, treat or cure that disease or condition. The research procedures may or may not benefit the patient volunteer, but clinical studies are always designed to help researchers learn something about the disease or condition and to one day help others. Researchers can learn more about the disease process by comparing patient volunteers to healthy volunteers, so they often need both types of volunteers.
Clinical studies all have a research plan, known as the protocol. A protocol describes who is eligible to participate; details about any tests, procedures, medications and dosages that will be used; and the length of the study and what information will be gathered. The protocol is carefully designed to safeguard the participants’ health.
Every clinical trial protocol in the U.S. must be approved and monitored by an independent committee of physicians, statisticians and members of the community to ensure that the risks are minimal and are worth the potential benefits. Federal regulation requires that all institutions in the U.S. conducting or supporting medical research involving volunteers have such a committee to approve the protocol before it begins and to periodically review the study. Members of the research team also regularly monitor the participants’ health during the study to determine its safety and effectiveness.
All clinical studies have guidelines about who can participate. The participants are selected according to factors such as age, gender, the type and stage of a disease, previous treatment history and other medical conditions. These criteria aren’t personal. They’re used to ensure that researchers identify appropriate participants to help them answer the questions they want answered.
If you consider participating in a trial, members of the research team will explain the details of the study to you in a process called informed consent. They will give you a document to sign that includes details about the study, such as its purpose, length, required procedures and who to contact for further information. The document also explains the risks and potential benefits of the study. If you decide to sign, you’re still free to withdraw from the study. Informed consent is not a contract; it’s to ensure that you understand enough about the study to decide whether or not to participate.
After a study is completed, the researchers carefully examine the information they’ve collected. The results are often published in scientific journals. If the new approach has been proven safe and effective, it may become standard practice.
Paul Covington, a retired basketball coach from Jackson State University, knew he hadn’t always followed a healthy diet even though he was quite active. So he decided to volunteer for a clinical study looking into blood pressure and heart disease. “At first, I did it for selfish reasons,” he said. “I had been coaching so long, I thought maybe getting in the program would help me find out if I had done any damage to my body.”
But then, he said, “After thinking about all of it, I found out in the long run this will help a lot of people. So what started out to be selfish will end up helping others.”
Many people might benefit from your participation in clinical research: your relatives, your friends and even you. Talk to your doctor or visit http://clinicaltrials.gov to find a clinical study near you.