The Importance of Volunteering in a Clinical Trial

Volunteers are a part of our everyday life, but they seem to be somewhat easily forgotten about. Think about it: you don’t often think about an EMT or volunteer firefighter—until you need their services. Most people have probably never thought about how clinical trial volunteers have helped in our everyday life. All drugs and devices have gone through the clinical trial process, and patient volunteers have helped researchers understand the safety and effectiveness of the drug or device to further develop them. Without the data and research compiled from trials, there would be limited progression in medical interventions. Not only do clinical trials look for patients with underlying medical conditions, but they also look for healthy patient volunteers. You could help in the advancement of medicine by being a volunteer.

What types of studies require people to volunteer?

Not all studies revolve around medications or devices; some look for prevention or ways to diagnose medical issues. One thing that remains the same in these trials is that they require human volunteers.

• Natural History Studies: provide information about the progression of diseases and illnesses.
• Prevention Trials: determine better ways for prevention and reoccurrence of diseases.
• Screening Trials: study the best ways to detect diseases and conditions.
• Diagnostic Trials: study what tests and procedures better diagnose certain diseases.
• Quality of Life Studies: explore ways to improve the quality of life for patients with chronic illnesses.
• Treatment Trials: study new treatments (i.e. drugs, surgery, radiation therapy).

People volunteer for many different reasons, but often these volunteers have a specific diagnosis and want to try the newest, most innovative treatment options. Another reason some people choose to participate in these studies is for financial reasons; by participating in clinical research, they have access to an alternative care option that is low-cost or no-cost. Other clinical trial participants are driven to progress the treatment options for future generations. Not all clinical trial volunteers are sick—there are also healthy volunteers in clinical studies. No matter the reason, the people who participate in a clinical trial are crucial in the development of drugs, devices, and procedures.

What is a "healthy volunteer"?

A healthy volunteer is someone with no known significant medical or health concerns that participate in a new study. Healthy volunteers provide data that can be used as a baseline in clinical studies. In many trials, researchers must compare data from healthy volunteers with those of people with specific conditions or illnesses. Healthy volunteers are recruited to serve as a control group in studies. According to the NIH Clinical Center, many times healthy volunteers are matched with someone that closely resembles them regarding age, gender, and family relationships. They are then given the same treatment or procedure. Alternatively, healthy volunteers may participate in biospecimen collection studies in which they donate a sample of blood, saliva, or other bodily substance. Many of these participants volunteer because they want to help others and contribute to the progression of science and medicine.

Why does volunteering matter?

Volunteers are needed to participate in clinical trials and to help progress medical discoveries. Without volunteers, clinical trials are not possible. Data is collected from all trial participants and studied to see how patients react to new drugs or medical procedures. This data is imperative in deciding the effectiveness of these new medical innovations. In addition, trials can study the effectiveness of new procedures compared to existing ones. Since technology is ever-changing, there are constantly new devices and treatments being developed. It is important to note that not all trials are drug-related as they also help in the advancement of procedures and devices. Whether to develop a new device, drug, or treatment or to test new methods against the current standard of care, real human data is how these advancements are made, which is why human volunteers are so important.

Is it safe to volunteer in a clinical trial?

Clinical trials all have varying degrees of risk—some may not have any risk, like donating a saliva sample for a biospecimen collection trial, or may have a significant risk of potential side effects. Regardless of the risk, each trial is put through a rigorous process to ensure patient safety before any volunteers participate. Researchers are required to follow strict rules that are enforced by the federal government to keep patients safe.

In addition to federal government involvement, the Institutional Review Board or IRB must approve each study in the United States. The IRB comprises several physicians, a scientist, a non-scientist, and a representative from the community where the trial is located. An IRB is required for every research project that involves people as study participants. They serve as an ethics review to ensure that the rights of research participants are protected—and protect the rights of future patients who might benefit from this trial research. They also ensure that each participant is given Informed Consent, which is a printed document containing information with sufficient trial details. It is given before a person participates and informs the patient of what to expect. Each volunteer meets with the doctor, research staff, or both to answer any questions you may have.

After the informed consent process, a patient has the choice to decide if they would like to continue participating in the trial or not. When a patient chooses to proceed, they will be asked to sign an informed consent paper. Even after this process, a patient may choose to leave the trial at any time, for any reason.

Ultimately, the choice to participate in a clinical trial is yours to make. To learn more about safety, expectations, and processes of clinical research, check out our Clinical Trial 101 guide.