Anyone! There are trials for people of all ages and backgrounds, including:

• Babies and children: Help researchers study investigational products to see if they are safe and effective for kids.
• People who are pregnant or may become pregnant: Help improve understanding of how investigational products affect pregnancy.
• Older adults: Help researchers learn how investigational products work for aging populations who often need medicine the most.
• Healthy people: Help researchers learn about the safety, dosing, and side effects of investigational products.

Medical treatments don't work the same for everyone. That's why it's important for clinical trials to include people from all backgrounds. This helps researchers learn how treatments work for everyone.

Because people are different, and investigational products don't always work the same for everyone. Things like age, sex, race, and genetics can affect how an investigational product works or what side effects may happen. By including people from different backgrounds in clinical trials, researchers can better understand how future treatments work for the people who need them.

People volunteer for clinical trials for many reasons. Some want to advance science or help doctors and researchers learn more about disease and improve health care. Others, such as those with an illness, may try new or advanced treatments that aren’t widely available.

Whatever your reason for joining a clinical trial, researchers generally need two types of volunteers: those without specific illnesses or conditions and those with them.

A healthy volunteer is someone in a clinical trial with no known related health problems. Researchers need healthy volunteers to establish a healthy or optimal reference point. They use data from healthy volunteers to test new treatments or interventions, not to provide direct benefit to participants.

A patient volunteer is someone in a clinical trial who has the condition being studied. Researchers need patient volunteers to learn if new tests, treatments, or preventive measures are safe and effective. Not all trial participants will receive experimental medications or treatments; sometimes, participants may receive a placebo. Researchers need to vary medications and treatments so they can compare results and learn from their differences.

While a study’s treatment or findings may help patients directly, sometimes participants will receive no direct benefit. However, in many cases, study results can still serve as building blocks that are used to help people later.

Clinical trials use randomization, placebos, and blinding to keep results fair.

Randomization means patients in a trial are placed into groups by chance.

A placebo is a product that looks like an investigational product but has no active medicine. Some trials use a placebo to compare results.

In double-blind trials, the patients and even the doctors don't know who is receiving which products. These methods help researchers get clear, unbiased results.

In many cases, your physician will be able to offer you information about opportunities to become participants in a drug trial. This is often the case if the drug’s possible effectiveness is greater than traditional methods of treatment.

A great online source is ClinicalTrials.gov. This is a federally supported and searchable registry for clinical trials pertinent to your condition: www.clinicaltrials.gov

Additionally, patient advocacy groups can offer helpful information about clinical trial opportunities specific to your condition.

If you don't qualify, ask your doctor about other trials or check clinical trial websites for more options.

Every trial is different. If you don't qualify at first, you may be able to try again later or join a different trial. Ask the trial doctor about your options.

Usually no. Most clinical trials do not allow people to take part in 2 or more trials at the same time.

Yes. You can continue seeing your regular doctor while participating in a clinical trial. The trial team may also work with your doctor.

If you decide that you no longer want to participate in a clinical trial, you can do so at any time. Simply inform the research team, and they will discuss the process of withdrawal from the study. Withdrawal will involve stopping the investigational treatment and may involve proceeding to the End of Study (EOS) and follow-up visits.

Some clinical trials offer compensation for your time or travel. Others do not. The informed consent form will explain any payments or reimbursements.

Some clinical trials offer support with costs like travel, lodging, or caregiver help. The resources available vary by trial. Ask the trial team during the prescreening process about what support may be available.

Your insurance should never be billed for study-related assessments.

The schedule of clinic visits is developed individually for each clinical trial and will be detailed in the informed consent form (ICF). In some cases, the participant needs to see a doctor several times a week; in other studies, visits can be no more than once a month. Therefore, it is vital to become acquainted with the details of the ICF and discuss any concerns with the research team.

Clinical trials can provide many benefits to participants and society. However, before volunteering for a clinical trial, you should talk with your health care provider and the study team about the risks and benefits.

Potential Risks

When weighing up the risks of volunteering, you should consider:

• The likelihood of any harm occurring
• How much harm could result from your participation in the study

Researchers try to limit patient discomfort during clinical trials.

Potential Benefits

The benefits of volunteering can include:

• Treatment with study medications that may not be available elsewhere
• Care from health care professionals who are familiar with the most advanced treatments available
• The opportunity to learn more about an illness and how to manage it
• Playing an active role in your health care
• Helping others by contributing to medical research

Strict rules and laws help protect participants in research studies, and the study team must follow these rules to conduct research. Below are some measures that can help ensure your safety.

Ethical Guidelines

Ethical guidelines protect volunteers and ensure a study’s scientific integrity. Regulators created these guidelines primarily in response to past research errors and misconduct. Federal policies and regulations require that researchers conducting clinical trials obey these ethical guidelines.

Informed Consent

Before joining a trial, you should understand what your participation will involve. The study team will provide an informed consent document with detailed information about the study. The document will include details about the length of the trial, required visits, medications, and medical procedures. It will also explain the expected outcomes, potential benefits, possible risks, and other trial details. The study team will review the informed consent document with you and answer any questions you have. You can decide then or later if you want to take part in the trial.

If you choose to join the trial, you will be asked to sign the informed consent document. This document is not a contract; it verifies you understand the study and describes what your participation will include and how your data will be used. Your consent in a clinical trial is ongoing and your participation is voluntary. You may stop participating at any time.

Institutional Review Board Review

Institutional review boards (IRBs) review and monitor most clinical trials in the United States. An IRB works to protect the rights, welfare, and privacy of human subjects. An IRB usually includes a team of independent doctors, scientists, and community members. The IRB’s job is to review potential studies, weigh the risks and benefits of studies, and ensure that studies are safe and ethical.

If you’re thinking about volunteering for a clinical trial, ask if an IRB reviewed the trial

Your trial team will monitor your health and provide medical care if needed. Any reactions should be reported to the trial team immediately.

Your identity and medical information are kept private, just like with your regular doctor. When research information is shared with the sponsor, your name and other personal details are removed so the sponsor does not know who you are.

Clinical trials employ different methods of recruiting study participants. The research center can review its existing databases of patients or medical charts to determine potentially eligible patients. Other recruiting methods include advertising in mass media (newspaper, radio, television, or Internet), public workshops, free health screenings, or forums.

During this process, the study staff will ask you a series of questions to confirm your willingness to engage in the clinical study and verify whether you meet the criteria for participation or not. This process typically happens during a phone call with site staff.

If you have determined eligibility during the pre-screening process, you will be scheduled for an appointment at the research site and meet with a member of the research team. Prior to initiation of any clinical screening procedures, you will discuss and be asked to sign an ICF. This document provides a detailed overview of the study, the possible risks and benefits, emergency contacts, and your rights as a research participant. The informed consent process also allows you to ask any questions you might have about participating in the study. You will receive a copy of the signed ICF to take home and keep for your records.

After you have given consent to participate in the clinical trial and signed the ICF, the site staff will begin guiding you through the screening procedures. These assessments are designed to determine if you meet the specific inclusion and exclusion criteria for the clinical research study you decided to join. The screening process includes completing questionnaires and answering a series of questions about your medical history, current and previous treatments. To confirm that you meet the study’s requirements, you may also have to undergo a physical exam, electrocardiogram (ECG), as well as blood and urine tests to assess your general health. The investigational product is not usually provided during the screening visit.

Upon satisfying the study eligibility criteria (which include acceptable laboratory and medical test results), you will be asked to come to the clinic for a series of study visits, also called “treatment visits.” Some of these visits may be conducted virtually. Study participants start receiving the investigational product or the comparator product (sometimes a placebo) during treatment visits. The frequency and duration of visits vary for every study.

The End of Study visit occurs once you are no longer receiving investigational treatment. This stage requires the same or similar tests conducted before receiving the first dose of the investigational product. The research team will also discuss your follow-up treatment options (which may include standard treatment for your condition or open-label extension study of the investigational product). Please note that you may be asked to return to the research site for a follow-up safety visit if required.

The number of follow-up safety visits and intervals may differ according to the type of study. The purpose of this stage is to make sure that you are not experiencing any persistent side effects from the investigational product or the overall study participation.