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The Clinical Trial Experience

Trial Hero

What to Expect as a Clinical Trial Participant

Learn more about the phases of clinical trials and the process of becoming a participant.

The Clinical Trial Participant Journey

Participating in a clinical trial is a voluntary decision, and you can choose to withdraw from the trial at any time if you change your mind. Before you enroll, you will go through a series of steps to ensure you meet the requirements of the trial and are informed about the risks and responsibilities of participating. This process will help you make an educated decision.
Pre-Screening

1. Pre-Screening

First, you will learn about the trial. This may be done via online education, through a contact center, or at an appointment with the local research team. This education usually includes an understanding of you (and if appropriate, your match to the trial), the trial’s purpose, treatment information, potential benefits and risks, the length of your participation, and an overview of the trial’s activities.
Consent

2. Informed Consent

You will be provided with a document that details what you need to know as a trial participant so you can make an educated (informed) decision on whether you would like to take part in the trial. The clinical research coordinator will review the document with you and answer any questions you may have. You may want to bring a family member or friend to your appointment to help write down answers to your questions. If you decide to participate in the trial, you will sign the form, which provides your consent and acknowledges your understanding of the risks and your responsibilities. Even if you sign the consent form, you may withdraw from the trial at any time.

The informed consent form covers topics such as:

  • Purpose of the research
  • Who is eligible to participate
  • Expected length of time for participation
  • A description of the procedures (exams, tests, etc.) that will be part of the trial
  • A description of any expected risks
  • Possible discomforts (e.g., injections, frequency of blood tests, etc.)
  • Handling of data (e.g., confidentiality, record keeping, FDA inspections)
  • Who covers the cost if a clinical trial causes an injury
  • Participant rights (e.g., the right to stop participation at any time)
  • Who to contact if you have questions
Screening

3. Screening

During a participant screening visit, the research team will review your medical history and conduct any other procedures and tests (such as blood work, vitals, body measurements, biopsies, or scans) to make sure you meet all requirements to join the trial.
Enrollment

4. Enrollment and Participation

If you qualify, your participation can begin. The research team will provide detailed instructions on what you may need to do at home, how often you will need to visit the trial site, and what will be required at the visits (e.g., physical exams, questionnaires, tests, and procedures). Your overall health and safety are continually monitored for the duration of the trial. Taking part in a trial may require more doctor visits than usual, however many trials offer some reimbursement for your participation.
Participation

5. End of Trial Participation

Each trial has predefined trial completion criteria. When you complete your trial participation, you may meet with your regular healthcare provider, if different than your research team, to determine further care options. If you are a healthy volunteer, your commitment is over. Keep in mind that researchers can decide to end trials earlier than expected for a variety of reasons. You may also withdraw your consent to participate at any point during the trial.

Who is involved in clinical trials?

Participant

An individual who has volunteered to participate in a clinical trial and meets all of the eligibility requirements of a participant.
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Clinical Trial Site

A clinical trial site is the location where the clinical trial takes place, and where participants meet with the research team (e.g., the principal investigator, clinical research coordinator). Clinical trial sites are typically universities, medical centers, clinics, hospitals, or other research sites.
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Principal Investigator (PI)

The person, often a physician, who is responsible for carrying out a clinical trial at the clinical trial site. They typically treat clinical trial participants and work with other members of the research team, such as clinical research coordinators and nurses.
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Clinical Research Coordinator (CRC)

The CRC conducts the day-to-day activities of a clinical trial. The CRC ensures the clinical trial follows the study requirements, regulations, Good Clinical Practice (GCP), and Institutional Review Board (IRB) or Ethics Committee (EC) requirements. They may also act as a liaison for the clinical trial site, recruit and/or register participants, and review data before it is entered into a trial database.
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Sponsor

A company, institution, or organization that is responsible for developing the treatment. They also manage, and/or finance the clinical trial. Many different organizations might sponsor clinical trials such as universities, health institutions, non-profits, or pharmaceutical companies. For example, Gilead is a sponsor of clinical trials.
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Ethics Review Board

Commonly known as the Institutional Review Board (IRB) or Ethics Committee (EC), the ethics review board is an independent body that consists of medical, scientific, and non-scientific members. It is established by an entity (often a hospital, research center, or university) to ensure the rights, safety, and well-being of human subjects who participate in biomedical or behavioral research are protected.

What to Expect as a Parent or Legal Guardian

Parent Guardian
Family decisions about children or others who have legal guardians can be extremely delicate. Even more than enrolling yourself, there may be a deeper level of anxiety.
If you are considering enrolling a family member, the research team will provide detailed information about the steps and activities of the trial, as outlined above in the Clinical Trial Participant Journey. If you decide to participate, parents or legal guardians must sign an informed consent form and, depending on age, the child will also provide assent (approval) to participate in the clinical trial.

Throughout the trial, research team members, including doctors and nurses, will be accessible to monitor your family member’s health. Remember: participation is voluntary—you have the right to stop your family member’s participation at any time by notifying the clinical research coordinator or PI of the trial. When the trial concludes, the team will work with your family to coordinate appropriate ongoing care.

Your Questions Answered

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

YOUR QUESTIONS ANSWERED

FAQ Topic:
ALL Clinical Trial Basics Safety and Security Trial Terms Defined The Clinical Trial

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

All trials have different timelines due to various factors, such as the trial phase, study design, treatment duration or health condition being studied. During the consent process before enrolling, the research team will explain the specifics about the trial.
Due to the many differences in insurance plans across the country, coverage in clinical trials can vary. You will learn more about your options during pre-screening.
If you are living with a medical condition, joining a clinical trial may give you access to a new potential treatment before it is publicly available. Just as importantly, it can help researchers understand how this potential treatment affects the body and increase their knowledge about the disease and how to treat it. Participation can also play a vital role in helping others who have a similar condition, both now and in the future. Healthy volunteers in trials contribute to this medical progress as well by helping understand the effect of the potential treatment and any safety concerns.
As with all medical records, participant privacy and confidentiality in trials are protected by law. Once consent is signed, you will be given a trial code. Your trial records will not include your name or personal identity but will identify you with a trial code. This code can only be tracked back to you via a code key which is held by the responsible physician. Your name or personal identity will never be disclosed.
Yes, participants are volunteers and may withdraw from a clinical trial at any time.
A placebo is an inactive version of an intervention that is not intended to provide any medical benefit. It is designed to look the same as the active intervention, so the participant and research team do not know it is a placebo. The placebo is used by comparison to confirm any effects of the intervention being studied, if no approved intervention is available.
"Standard of care" is an intervention already approved for a specific health condition that is available publicly. Interventions in a clinical trial are still being tested to ensure safety and effectiveness.
Some clinical trials are designed to be "double blind" so both participants and researchers are unaware of which treatment group participants are assigned to. This prevents bias from affecting clinical trial data.
Your informed consent is required before being enrolled in a trial. This means you have been provided all relevant information about the study design, how you will participate, your right to withdraw at any time, study alternatives, your personal data protection and the associated risks and benefits. Informed consent is designed to protect patient safety and privacy.
Under FDA regulations, an Institutional Review Board (IRB) is a group that has been formally designated to review and monitor research at a hospital or institution involving human participants. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in, or disapprove research.
Participants are always welcome to visit their usual healthcare providers during a trial. Sometimes, it is important for healthcare providers to collaborate with the research team to ensure success.
After your participation ends, the study may continue for months or years. Once final results from all participants are compiled and analyzed, they are often published publicly. Clinical study report (CSR) synopses and plain language summaries (PLSs) may be made available for certain studies. Check with your clinical trial site or send an email to [email protected] to learn more.
There are a wide variety of professionals involved with any clinical trial, all of whom are vital to ensuring safety and success. The principal investigator, or PI, leads the trial and directs the team of doctors, nurses and other healthcare workers. The clinical trial coordinator manages day-to-day activities and is the main contact for participants. Many clinical trials also have an independent Data and Safety Monitoring Board (DSMB) who periodically reviews data to ensure participant safety, and sometimes effectiveness.
If you don’t qualify because you don’t meet the trial criteria, consider discussing other options with your healthcare provider or the patient’s physician would need to submit a managed access request based on the eligibility. Click here to learn more.