Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

All clinical trials have guidelines regarding participant eligibility. Inclusion and exclusion criteria are essential principles of medical research that help produce reliable results. "Inclusion criteria" refer to the factors that allow someone to participate in a clinical trial, while "exclusion criteria" identify factors that disqualify someone from participation. These criteria may include factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Before joining a clinical trial, participants must meet the study’s eligibility requirements. Some research studies seek participants with specific illnesses or conditions relevant to the trial, while others require healthy participants. It’s important to understand that inclusion and exclusion criteria are not intended to personally reject individuals. Instead, they are designed to identify suitable participants and ensure their safety. These criteria also help researchers effectively address the questions they aim to study.

The clinical trial process varies depending on the type of trial being conducted (see “What are the different types of clinical trials?”). The clinical trial team typically includes doctors, nurses, and other healthcare professionals. They assess the participant's health at the beginning of the trial, provide specific instructions for participation, monitor the participant closely throughout the trial, and maintain communication after the trial is completed.

Some clinical trials may involve more tests and doctor visits than what a participant would typically experience for their illness or condition. In all types of trials, participants work closely with the research team. Successful participation in a clinical trial relies on following the protocol carefully and maintaining frequent contact with the research staff.

Informed consent is the process of learning key facts about a clinical trial before deciding whether to participate. It is also an ongoing process throughout the study, providing continuous information to participants. To help individuals make informed decisions, the doctors and nurses involved in the trial explain the study's details. If a participant’s native language is not English, translation assistance can be provided.

The research team then presents an informed consent document that outlines important information about the study, including its purpose, duration, required procedures, and key contacts. Risks and potential benefits are also detailed in the document. Participants have the option to decide whether to sign the document. Importantly, informed consent is not a contract, and participants may withdraw from the trial at any time.

Benefits

• Active Role in Healthcare: Participants can take an active role in their own health care.
• Access to New Treatments: They gain access to new research treatments before these options are widely available.
• Expert Medical Care: Participants receive expert medical care at leading healthcare facilities during the trial.
• Contribution to Medical Research:By participating, they help advance medical research and contribute to the wellbeing of others.

Risks

• Side Effects: Participants may experience unpleasant, serious, or even life-threatening side effects from the experimental treatment.
• Effectiveness: The experimental treatment may not be effective for the participant.
• Time and Commitment: The trial protocol may require more time and attention than standard treatments, including additional trips to the study site, more treatments, potential hospital stays, or complex dosage requirements.

Side effects are any undesired actions or effects resulting from the experimental drug or treatment. Adverse effects can include symptoms such as headaches, nausea, hair loss, skin irritation, or other physical issues. It is essential to evaluate experimental treatments for both immediate and long-term side effects.

The ethical and legal codes that govern medical practice also apply to clinical trials. Furthermore, most clinical research is federally regulated and includes built-in safeguards to protect participants. Each trial follows a carefully controlled protocol, which is a detailed plan outlining the researchers' actions throughout the study. As clinical trial progresses, researchers report the results at scientific meetings, in medical journals, and to various government agencies. Individual participants' names will remain confidential and will not be disclosed in these reports.

Participants should be well-informed about the clinical trial and feel comfortable asking the healthcare team any questions regarding the study, the care they can expect while participating, and any associated costs. The following questions may be helpful for participants to discuss with the healthcare team. Some answers can also be found in the informed consent document.

Participants should be well-informed about the clinical trial and feel comfortable asking the healthcare team any questions regarding the study, the care they can expect while participating, and any associated costs. The following questions may be helpful for participants to discuss with the healthcare team. Some answers can also be found in the informed consent document.