Frequently asked questions
Clinical trials (or research studies) are a type of medical research in which people volunteer to take part. Clinical trials commonly study how potential drugs and other medical treatments affect the participants.
All drugs that become available for use in people are first tested in clinical trials involving hundreds to thousands of people.
What happens in a clinical trial depends on the protocol. A protocol is a detailed plan that explains the purpose of the clinical trial and how it will be run. If you consider joining a clinical trial, these details will be explained to you as part of the informed consent process. They include:
- the length of the clinical trial
- the study drugs, procedures and tests in the clinical trial
- the schedule of study activities
- information about who can participate
- how side effects will be tracked, managed and reported
- the rules that must be followed
In a single-blind trial, the participants do not know whether they are receiving the study drug or placebo, but the researchers know.
In double-blind trials, neither the participants nor the researchers know whether the participants are receiving the study drug or placebo. (If necessary, such as for a safety reason, the researchers can find out what a participant has received.)
In open-label trials, both the participant and the study doctor will know which treatment the participant is receiving. .
- As part of a clinical trial, your study-related medical care is provided by the study team at the location where you’re participating. This includes the principal investigator (or study doctor) — the healthcare professional who conducts and takes responsibility for the trial at that location — as well as other clinical study team members. This may or may not be your regular doctor.
- During your clinical trial participation, you may also continue to see your regular medical doctors for any care that is not related to the study. It is important for you to tell your study team about other conditions you might have and to let them know which other doctors are caring for you. This helps the study team coordinate your overall care.
- If you participate, the clinical trial will provide study-related medical care, and your regular medical doctors will address the other aspects of your health. Your regular medical doctors can also work with the study team to understand the details of the clinical trial and any impact it may have on your regular medical care.
All clinical trials have possible risks. The known and unknown risks of participating in a specific study will be explained to you during the informed consent process that happens before you decide whether to participate.
Clinical researchers must follow guidelines and regulatory requirements to help protect the rights, safety and well-being of clinical trial participants. These include Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing and conducting clinical trials.
There are also many entities that provide oversight of clinical trials. These include health authorities or regulators, institutional review boards and independent ethics committees, and data safety and monitoring boards.
We encourage everybody to consider joining clinical trials. There are many types of clinical trials that study different aspects of health in people with a variety of backgrounds and conditions. Each clinical trial has its own criteria for who may participate. These are called eligibility criteria.
Eligibility criteria include things like your age, sex, overall health, type of condition and your medical treatment history. As part of the steps to join a clinical trial, the study doctor will confirm whether you meet all eligibility criteria and are able to participate.
Participation in a clinical trial is always voluntary. The decision to join is personal, and it is yours.
The study drug and any study-related procedures will generally be provided at no cost to the participant.
Pfizer is also committed to reimbursing participants for reasonable clinical trial-related expenses such as transportation, parking and meals.
Because each clinical trial is different, we encourage you to ask the study team any questions you have. You can also refer to the informed consent document for the details about any costs for study participants and study-related reimbursement.