Adverse Reactions or Side Effects: Adverse reactions or side effects are undesired physical reactions to a study drug or device.
Blinded Study: In a blinded study, study volunteers are randomly assigned (like a flip of a coin) to receive different treatments. The volunteers and/or study team members do not know which volunteers are getting which treatment.
Clinical Study: A study with human volunteers that tests how well a study drug, device or other treatment works for treating a disease or condition. It also tests how safe the study drug, device or other treatment is for people. A clinical study may also be called a clinical trial or clinical research.
Control Group: Study volunteers that will not receive the study drug are called a control group. The control group can receive a placebo, which is a harmless substance that looks like the study drug and has no impact to the body.
Eligibility Criteria: Each study has study criteria or rules about who can be in a study. Study criteria are carefully chosen to make sure the trial can prove whether a study drug works or not in certain volunteers. The rules are applied equally to all those who could be in the study. These rules or criteria include things like your age, your gender, type and stage of a disease, prior treatment history, and other medical conditions.
Healthy Volunteer: A person in a research study who does not have significant health problems.
Informed Consent: This is the process where a study team member will explain the study and you can ask questions. It is important that you understand the facts of the study so you can make an informed choice about being in the study. In this process you will learn why the study is being done, what you will need to do for your part in the study, how long the study lasts, and known risks and potential benefits of being in the study.
After hearing the study details and getting answers to all your questions, you can decide if you want to be in the study. If your decision is to take part, you sign a document called an informed consent that shows you understand the known study facts and want to be in the study. Signing an informed consent document is not a contract and you can leave a study at any time.
Interventional Study: A study that tests how safe and how well a new drug, device or other medical intervention works in people.
Observational Study: Observational studies do not include any sort of treatment. The researchers observe and measure certain outcomes. This type of study tries to find out why certain physical or behavioral things happen in relation to a disease or treatment. These studies usually collect large amounts of information over time.
Placebo: A substance that does not have study drug in it and will have no impact on the body. It looks the same and is given in the same way as the test drug being studied.
Principal investigator (PI): The doctor or researcher in charge of the clinical study.
Protocol: This is the written description of a clinical study. It includes why the study is being done, how the study will be done, and when each step will need to take place during the study. It also includes information from earlier research done in labs and sometimes earlier studies in people.
Randomized Study: In these studies, volunteers are divided by chance into separate groups. Different treatments are given to the volunteers in the different groups. Using chance to divide people into groups means that the groups will be similar and that the effects of the treatments they receive can be compared more fairly.
Side Effects or Adverse Reactions: Side effects or adverse reactions are undesired physical reactions of a study drug or device.
Study Volunteer: A study volunteer can also be called a study participant or a patient. Study volunteers are the medical heroes who shape the future of healthcare!