Blinded Study
- A type of research where the participants do not know which treatment they receive. There are two types of blinded studies, single and double.
- In a single-blind study, only the participants are unaware of the treatment they receive, while the researchers know.
- In a double-blind study, neither the participants nor the researchers know who is getting the real treatment and who is getting a placebo. This helps ensure that the results are more reliable. See: randomization.
Clinical Study
- A clinical study (also known as a clinical trial) is the scientific investigation of new treatments, medications, or procedures in people to determine their effectiveness and safety. There are four phases of a clinical study.
Eligibility Criteria
- The specific rules or requirements that must be met for someone to participate in a clinical study. These can include age, health condition, and medical history. Before you can be enrolled in a study, the research team will review your medical records and run tests to ensure you meet the eligibility criteria for the study.
Informed Consent
- A process where you are given detailed information about the study, including its purpose, procedures, risks, and benefits, and you agree to participate by signing a document known as an informed consent form.
Informed Consent Form (ICF)
- A written document that provides detailed information about the study and confirms that you understand and agree to participate. It is part of the informed consent process.
Open-Label Treatment Period
- A period of time in a clinical study where the participants and researchers know what treatment the participants receive. Typically, no placebo is given to participants during this period, so everyone has access to the study medication. An open-label treatment period is usually an extension to a single- or double-blind period.
Phases
- Clinical studies have four phases, during which researchers must follow strict rules to keep participants safe. If you're curious about the phases, you can read The Four Phases of Clinical Studies to learn more.
Placebo
- An inactive treatment, or sugar pill, which is given to patients to help researchers determine if the real study drug is more efficient.
Principal Investigator
- The physician who is responsible for the scientific and technical direction of the entire clinical study.
Protocol
- A detailed plan that outlines how a clinical study will be conducted, including what procedures will be followed, what treatments will be tested, and how data will be collected.
Randomization
- The process of assigning participants to different treatment groups by chance, similar to flipping a coin. This helps ensure that the results are not biased and that the treatment effects can be accurately measured. This process is used for a double-blind treatment period.
Research Site
- A facility where patient recruitment and study procedures take place under the supervision of qualified medical professionals. Research sites may include a hospital, university, or clinic.
Screening Period
- The screening period is when the study team evaluates whether people are eligible to take part in the clinical trial. Various medical tests will occur, and the person will be asked about their personal and family medical history. If a patient passes the screening criteria during this period, they can enroll in the clinical study.
Screening Visit
- If a research site believes a patient is a good candidate for a clinical study, they will schedule a screening visit. During the screening visit the patient will sign the ICF and enter the screening period.
Side Effect
- An unwanted effect or reaction to a treatment or medication that is usually known and documented. Side effects are a key part of evaluating the safety of a new treatment.
Sponsor
- The organization or individual that initiates, funds, and oversees the clinical study. Sponsors ensure that the study is conducted properly and that all regulatory requirements are met.
Study Coordinator
- A research professional working with and under the direction of the clinical Principal Investigator (PI). The study coordinator supports, facilitates, and coordinates the daily clinical trial activities.
Study Drug
- The experimental treatment which is being evaluated in the clinical study. Also known as study medication, investigational treatment, or investigational product.
