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Frequently Asked
Questions & Glossary

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These terms are often used when describing clinical trials:

An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse events may be mild, moderate, or severe, and may be caused by something other than the drug or therapy being given. Also called adverse effect [adapted from Cancer.gov dictionary]
When describing a drug, “approved” usually means that your country’s regulatory agency allows it to be prescribed to patients by doctors.
see research study
In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect.
In research studies, an event or outcome that can be measured objectively to see if the intervention being studied is beneficial. Some examples of endpoints could be better disease control (like A1c control in diabetes), relief from symptoms, or living longer.
A list of characteristics that a person cannot have in order to be eligible for a research study. Examples of exclusion criteria are being outside the allowed age range, taking certain medications, or having a certain disease or condition other than the one being studied.
A list of characteristics that a person must have in order to be eligible for a research study. Examples of inclusion criteria are being within the allowed age range, having certain disease characteristics, and being able to willingly consent to joining the study.
A process that is part of every medical research study, in which patients are given important information to help them decide if they want to participate in the trial. It includes discussing possible risks and benefits. Patients are also given any new information that might affect their decision to continue. Also called consent process.
A group of scientists, doctors, clergy, and patient advocates that reviews and approves the detailed plan for a research study in people. IRBs are meant to protect the people who take part. They check to see that the trial is well designed, legal, ethical, does not involve unneeded risks, and includes a safety plan for patients. There is an IRB at every health care facility that does medical research, and every research study is reviewed by an IRB before it can begin.
A research study that is done to learn about the effect of an intervention, or action taken to improve health. The intervention could be a drug, medical device, procedure, vaccine, or even diet changes, exercise, or education. The study could include a group of participants that don't receive the intervention.
Describes any drug or treatment being tested in a research study. An investigational medication has not been approved by Regulatory authorities for the use in which it is being studied. It means that it has been tested in the laboratory and can be tested in people according to the rules of your country’s regulatory agency. A drug that is already being prescribed for one disease or condition can be considered investigational in other diseases or conditions. The word “experimental” may also be used.
A research study that collects information from participants as they go about their usual medical treatment or activities. There is no attempt to affect the outcome.
A person who enrolls in a research study. The word “participant” is used to reflect the fact that the person has voluntarily decided to participate in the trial. You may see the word “subject” or “patient” used in place of participant.
Medical research studies are usually conducted in phases (1, 2, 3, or 4) that build on one another. Each phase is designed to answer certain questions. In earlier phases, the focus is on safety and how a drug or treatment works. In later phases, the focus is on how well a drug or treatment works and its safety.
An inactive substance or other intervention that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug or other intervention are compared to the effects of the placebo. Often when a placebo is used, it is given with the standard of care, so that no one in the trial goes without treatment.
A written document that describes why a research study is being done and how it is to be conducted. It outlines how study participants and the integrity of the data collected will be protected. The doctors and staff on a study team use this document as a guide to what they need to do during the research study.
An independent government body that regulates a particular sector of the economy or society. Each country has its own regulatory agencies. Agencies such as the Food and Drug Administration (FDA) in the United States, European Medicines Agency (EMA) in the European Union, and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan are involved in regulating medical research.
A test of how well new medical approaches work in people. Research studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called a clinical trial or clinical study.
In a research study, it is the period of time during which tests are performed to confirm that you are eligible for (able to participate in) the study and that the study is right for you.
A person, company, institution, group, or organization that oversees or pays for a research study and collects and analyzes the data, but does not actually conduct the investigation.
Treatment that is accepted by medical experts as a proper treatment for a disease and that is widely used by healthcare professionals. Also called best practice, standard medical care, and standard therapy.
Any medicine that is being studied in a research study. See investigational for more information.
The hospital, clinic, or doctor’s office where a research study takes place. A study site must go through an approval process to be part of a research study.. Study sites are often “centers of excellence” and have the expertise and resources to be able to carry out the study properly.

Frequently Asked Questions

Learn more about clinical trials.

Everyone! There are research studies for healthy people, people with a medical condition, and people of all ages and backgrounds.
Because humans are diverse! All different types of people need medicines. That means that for a new medicine to truly help the people it is intended for, a diverse group of people need to be part of research studies for that medicine.
The researcher protects your identity and medical information just like your doctor does. When research information is shared with the sponsor, your name and other direct identifiers are removed so the sponsor does not know who you are.
Many different people! These include the sponsor the study (for example, a pharmaceutical company), your country’s regulatory agency, an Institutional Review Board at the medical center where the study is taking place, the team of study doctors, nurses, and others who carry out the study, and even your own doctor, who can help make sure the study is right for you.

Your safety is everyone's number one priority!
You can Search for available trials on your own. One place to start is ClinicalTrials.gov, which lists research studies that are being done all over the world.

Talk to your doctor or trusted medical professional. If you are interested in a specific research study, your doctor can reach out to the doctor involved in the study. Your doctor can also search for studies that might be right for you.

You can also call the hotline or visit the website listed on a research study poster or brochure in your doctor’s office or hospital.
When a research study ends, your participation typically ends too. In some cases, there may be an option to keep taking the study treatment as part of what is called a “long-term extension study”. In other cases, a study may end early because the treatment becomes “approved”, which means doctors can prescribe it for their everyday patients.
Every research study is different. If you don’t qualify at first, ask the study doctor if you can be screened again in the future. You can also see if you are eligible for a different study. You typically cannot be in 2 studies at the same time.
Being in a research study is 100% your choice! You can leave at any time, for any reason. There are no penalties and it does not affect your regular medical care. You should talk to the study staff about why you are leaving–there may be solutions for any problems that arise. The study doctor may ask you to come back for follow-up visits for your health and safety.
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