Clinical Studies and Clinical Trials Flashcards
What is a clinical trial?
A clinical trial is a research study conducted with human participants to evaluate the effects, safety, and efficacy of medical interventions.
True or False: All clinical studies require approval from an Institutional Review Board (IRB).
True
Fill in the blank: The main purpose of an IRB is to protect the ______ of human subjects.
rights and welfare
What are the phases of clinical trials?
Phases of clinical trials include Phase I, Phase II, Phase III, and Phase IV.
Which phase of clinical trials primarily assesses safety?
Phase I
What is the typical duration of a Phase III clinical trial?
Phase III trials typically last several years.
Multiple Choice: What is a common reason for a clinical trial to be terminated early?
A. Lack of efficacy B. Participant safety concerns C. Funding issues D. All of the above
What does the acronym ‘GCP’ stand for in clinical research?
Good Clinical Practice
True or False: Clinical trials must be registered before enrollment begins.
True
What is the purpose of a placebo in clinical trials?
To serve as a control to compare the effects of the experimental treatment.
Fill in the blank: The ______ is responsible for monitoring clinical trial progress and ensuring compliance with regulations.
sponsor
What is informed consent in the context of clinical trials?
A process by which participants are fully educated about the trial’s risks, benefits, and procedures before agreeing to participate.
Multiple Choice: Which document outlines the study protocol in a clinical trial?
A. Investigator’s Brochure B. Clinical Study Report C. Study Protocol D. Informed Consent Form
What is the role of a Data Safety Monitoring Board (DSMB)?
To review data and ensure participant safety during a clinical trial.
True or False: Phase IV trials are conducted after a drug has received marketing approval.
True
What does ‘randomization’ mean in clinical trials?
The process of assigning participants to different groups by chance to reduce bias.
Fill in the blank: The ______ is the group that receives the experimental treatment in a clinical trial.
treatment group
What does the term ‘endpoint’ refer to in clinical trials?
The primary outcome or measure used to assess the effectiveness of a treatment.
Multiple Choice: What is an observational study?
A. A study where participants are assigned treatments B. A study that observes participants without intervention C. A study testing a new device D. None of the above
What is a double-blind study?
A study design in which neither the participants nor the researchers know who is receiving the treatment or placebo.
True or False: Clinical trial results must be published regardless of the outcome.
True
What is the significance of the ‘ClinicalTrials.gov’ registry?
It is a database of privately and publicly funded clinical studies conducted around the world.
Fill in the blank: The ______ phase of clinical trials typically includes thousands of participants.
Phase III
What is a common ethical concern in clinical trials?
Ensuring informed consent and participant safety.
Multiple Choice: Which of the following is NOT a type of clinical trial?
A. Interventional B. Observational C. Retrospective D. Prospective
What is the purpose of a clinical study report (CSR)?
To provide a comprehensive summary of the trial’s methodology, results, and conclusions.
