Study Description Terms

Clinical Trial Phases:

Phase 1:

Small-scale study (between 20 to 100 participants) that determines the safety and dosage of a new treatment or drug.

Phase 2:

Medium study (between 100 and 300 participants) that evaluates the effectiveness and side effects of the treatment being tested.

Phase 3:

Large study (over 300 participants) that provides more reliable and generalizable findings to assess the treatment’s effectiveness.

Eligibility:

Refers to the criteria that individuals must meet to participate in a research study.

Estimated Enrollment:

The process of enlisting and registering participants in a research study. The number shown is the anticipated or expected number of participants.

Intervention Overview:

A detailed explanation of the treatment, intervention, or procedure introduced by researchers to examine its effects on participants. It gives insights into why it”s done, how it”s carried out, and the different approaches used in the intervention.

Interventional Study:

A type of research in which researchers actively introduce a specific treatment, intervention, or procedure to study its effects on participants.

Observational Study:

A type of research in which researchers collect data by observing and recording events, behaviors, or characteristics of participants without actively intervening.

Prospective Study:

A type of research in which data is collected from participants over time, often starting in the present and continuing.

Recruitment Status:

Active Not Recruiting:

The study is ongoing, but it is no longer accepting new participants.

Not Yet Recruiting:

The study is not yet actively accepting participants. It is in the pre-recruiting phase.

Recruiting:

The study is currently seeking and recruiting individuals to take part.

Selection:

The process of choosing participants, either through randomized or non-randomized methods.

Randomized:

Participants are chosen in a completely random and unbiased manner. This approach involves using chance or a random process to ensure that each participant has an equal opportunity to be selected.

Non-randomized:

Participants are assigned to groups based on specific factors or criteria determined by the research team.

Site:

A clinical trial site is a specific location or institution where the trial is conducted, responsible for participant recruitment, enrollment, administering study protocols, and collecting data. The Principal Investigator (PI) play a central role in overseeing and leading research efforts.

Study Design:

Outlines the plan or structure of a research investigation.
Study Outcome: The specific result that researchers measure or observe during a research study.

Study Size:

Refers to the number of participants included in a study, based on the research objectives and the nature of the medical intervention or drug being studied.

Treatment:

Within the scope of a clinical study, treatment includes specific therapeutic measures or procedures systematically administered to participants to examine their impact on health outcomes. Frequently, studies are organized through the implementation of distinct intervention protocols organized into separate groups of patients.