Adverse event

:

 Any negative or unintended effect of a treatment.

Clinical Research

:

 The process of studying and testing new treatments and therapies in human subjects.

Clinical Trial

:

 A study in which human subjects are assigned to different interventions, such as new drugs or therapies, in order to evaluate their effects on health outcomes.

Clinical trial protocol

:

 A detailed plan that outlines how a clinical trial will be conducted.

Double-blind study

:

 A study in which neither the participants nor the researchers know which treatment a participant is receiving.

Healthy Volunteer

:

 A person without significant health issues who participates in clinical research as a test subject for new drugs, devices, or interventions.

Inclusion/Exclusion Criteria

:

 Factors used to determine eligibility for participation in a clinical trial. Inclusion criteria are the criteria that must be met for a person to be included in the study, while exclusion criteria are criteria that would prevent a person from participating.

Informed consent

:

 A process in which a person is provided with information about a clinical trial and then decides whether or not to participate.

Institutional Review Board (IRB)

:

 A group of experts that reviews and approves clinical trials to ensure that they are ethical and that the rights of participants are protected.

Patient Volunteer

:

 A person who has a known health condition and participates in research in order to improve understanding, diagnosis, treatment, or cure of that disease or condition.

Phases of Clinical Trials

:

 Clinical trials are usually regulated in several stages, each with a specific purpose and objective.

1. Phase I trials

:

 The first stage of clinical trials, involving a small group of people (20-80), to test the safety and identify any side effects of an experimental drug or treatment.

2. Phase II trials

:

 The second stage of clinical trials, involving a larger group of people (100-300), to evaluate the effectiveness and further assess the safety of the experimental drug or treatment.

3. Phase III trials

:

 The third stage of clinical trials, involving a large group of people (1,000-3,000), to confirm the effectiveness, monitor side effects, and compare the experimental drug or treatment to standard or equivalent treatments.

4. Phase IV trials

:

 The final stage of clinical trials, conducted after a drug has been licensed and approved by the FDA, to gather more information on its risks, benefits, and optimal use.

Placebo

:

 A treatment that has no active ingredient and is used as a control in a clinical trial.

Power analysis

:

 A statistical method used to determine the sample size needed for a study to have a certain level of statistical power.

Principal investigator (PI)

:

 The person who is responsible for the overall conduct of a clinical trial.

Protocol

:

 A detailed plan that outlines the procedures, methods, and guidelines to be followed in a clinical trial. It is designed to ensure the safety of participants and to address specific research questions.

Randomized controlled trial (RCT)

:

 RCT is a study design in which participants randomly receive one of the multiple interventions being tested, such as a new treatment or a placebo. RCTs are considered a highly rigorous method for determining the effectiveness of a new treatment and are often considered the gold standard in clinical research.