Why participate in a clinical trial?

All approved medicines have one thing in common: they were evaluated in strictly controlled and highly regulated clinical research studies. This process ensures that potential new medicines are safe and effective for use. Participation in clinical trials is at any time entirely voluntary and may benefit people worldwide by helping to potentially develop novel medicines and improve existing ones.

Here are a few things to keep in mind when considering participating.

Possible benefits of participating in a clinical trial

Medical need

New medicines aim to fill an existing medical need. By participating in a clinical trial, volunteers could be supporting a project that evaluates the potential health benefits of an investigational medicine and thereby help other people worldwide.

Transparency

Participants are fully informed about all aspects of their participation. Medical staff carrying out the clinical trials provide background information on the investigational medicine and details on the trial protocol.

Controlled and supervised process

Clinical trials follow strict protocols at every phase. All participants are closely monitored and supported by medical staff throughout the trial.

Voluntary participation

Participants can withdraw from a clinical trial at any time without any consequences. Reasons for leaving can remain private and do not need to be shared with the medical staff.

Personal data protection

Personal data is strictly confidential, and will not be shared with any third parties, including BioNTech. The trial data are anonymized, so they can only be traced back to the participant by the dedicated research team which is bound by medical confidentiality.

Possible risks of participating in a clinical trial

Assignment to a control group

Participants cannot choose the treatment option they receive, including the dosage level or if they get a placebo or standard of care treatment rather than the investigational treatment.

Potential medical risks

The investigational treatment might not be better than existing treatments and could even lead to additional side effects.

Time commitment

Participating in a trial may require more physician visits than usual.

Diversity and inclusion in clinical trials

Diversity in clinical trials is important to advancing health equity and evaluating if an investigational medicine works for different groups of people and reflects the patient population likely to get treated with this medicine, if approved, regardless of their ethnicity, gender, socioeconomic status, age, ability and so forth. Still, many clinical trials lack enough participants or diversity. Many underrepresented communities may not even know they are underrepresented in research.

We at BioNTech set up clinical trial sites around the world and encourage people of all backgrounds to explore participation opportunities.

Frequently asked questions

What should participants consider before taking part in a clinical trial?

Before participating in a clinical trial, all potential benefits and risks should be considered. A clinical trial can give patients access to an investigational treatment before it is approved and therefore widely available. Patients may also be provided with more intensive care by medical staff than it would be the case during other treatment. Participating in a clinical trial can help people with a similar condition and advance medical research. At the same time, there might be certain risks associated with participating in a clinical trial. For example, the investigational treatment may not be effective or may be less effective than the current standard of care, if available. In addition, adverse events may occur. It is important to note that participants can leave the study at any time without giving a reason.

Do participants get paid to be in a clinical trial?

In some cases, monetary compensation may be provided. The research team can give more information about this topic during the pre-screening process.