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What to expect as a participant of a clinical trial

After deciding to consider joining a clinical trial, potential participants go through several steps to ensure they match the trial’s requirements and can make an informed decision about proceeding.

Pre-screening
Consent
Screening
Enrollment
Participation
End of clinical trial

The medical staff conducting the clinical trial will schedule an appointment to learn more about the potential participants and provide details about the trial. They will explain the trial’s purpose, potential benefits and risks, the length of a potential participation, information about the investigational treatment and an overview of the procedures. It is important to note that not all volunteers will meet the requirements to participate in the trial and their involvement may end at this step.

If the volunteers are eligible to participate and decide to join the trial, they must sign an informed consent form that acknowledges they understand what will or what may happen during the trial. The informed consent also identifies their rights and responsibilities, including the right to leave the clinical trial at any time.

During this step, the medical staff reviews the volunteers’ medical history and conducts a physical exam to make sure they meet all requirements for joining the trial. Each trial has different participation requirements, known as eligibility criteria.

Once it has been confirmed that the participants meet the eligibility criteria, they can be enrolled in the trial. Participants will meet with the research team to discuss next steps, including instructions on what they need to do at home, how to contact the research team if needed, how often they need to visit the trial center, and which procedures (such as physical exams, laboratory tests or questionnaires) will be performed at each visit.

Each clinical trial varies in the number of visits and other requirements. What all trials have in common is that the health and safety of the participants is at utmost priority which is why participants are closely monitored throughout the trial.

Once the clinical trial ends, the participants meet with the medical staff again to discuss next steps such as further care options. If participants took part in a trial as healthy volunteers their commitment ends. It is important to keep in mind that the medical staff carrying out the clinical trial can decide to end clinical trials earlier than expected, depending on the trial’s progress. If this is the case, the research team along with the treating physicians will discuss the best options for continuing the care of the participants.

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What to expect as a caregiver

Caregivers play an important role in the clinical trial process. If a family member or care recipient is participating in a clinical trial, caregivers may need to support them during their participation.

Support needs can vary. Sometimes, it is about offering emotional support or helping them travel to and from the trial center. In some cases, the caregiver may be asked to actively support the trial, for example by participating in the trial visits. Caregivers’ support is vital and their involvement makes a difference in the trial’s success and their family member’s or care recipient’s well-being.

Frequently asked questions

How can volunteers become part of a clinical trial?

Volunteers who match study requirements – such as gender, age, condition, or treatment history – can join a clinical trial. Each volunteer will be screened by a medical professional to confirm they meet the requirements of the respective trial.

What are the requirements for joining a clinical trial? Why are they important? 

Each clinical trial has different requirements, the so-called eligibility criteria, which determine whether a potential volunteer is suitable for participation in a trial. The eligibility criteria are important to generate comparable results and to be able to assess the safety and efficacy of an investigational treatment. Potential volunteers can ask their physician if they meet the eligibility criteria of a certain trial.

What rights do participants have in a clinical trial? / Can participants quit a clinical trial? 

Taking part in a clinical trial is voluntary and entirely up to the participant. Even if participants decide to take part, they can change their mind later and withdraw from the trial at any time without giving a reason.

Do clinical trial participants have any responsibilities?

As long as patients or healthy volunteers are participating in a clinical trial, it is important that they take the investigational treatment as planned and participate in scheduled visits with the responsible physicians and medical staff. Participants are also expected to take care of their health and avoid unnecessary risks. Of course, participants can leave the study at any time without giving a reason.

Do participants still see their primary care physician while in a clinical trial? 

Participants are always welcome to visit their usual physicians during a trial, and sometimes it is important for them to collaborate with the physicians in the trial team.

How can participants prepare for a clinical trial?  

Before joining a clinical trial, it can be helpful for potential participants to learn about the condition and the investigational treatment. If participation in the clinical trial is an option, this can be discussed with the treating physician or medical staff as part of the clinical research team. Volunteers are encouraged to bring any questions they might have when they meet the medical staff for the pre-screening. Important considerations include potential benefits and risks, responsibilities during the trial and duration of the trial.

Will participants get the results of the clinical trial they’ve participated in? 

After an individual patient’s participation ends, the study may continue for months or even years. Once final results from all participants are compiled and analyzed, they are often published publicly. The research team can give more information about this.

Will the visits be covered by insurance? 

Due to the many differences in insurance plans around the world, coverage in clinical trials can vary. The medical staff carrying out the clinical trial will discuss this topic with potential participants during the pre-screening process.

What if a volunteer does not qualify to participate in a clinical trial?

If a volunteer does not meet the eligibility criteria, they should check with their treating physician or healthcare provider to seek other options.

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