Clinical Trials Fundementals Flashcards

What are the two main types of clinical studies?

Interventional studies and observational studies.

What is the aim of interventional studies?

To test whether giving the study participants some kind of intervention alters the development, or the course, of an outcome.

What is a key characteristic of observational studies?

Investigators observe the course of a disease or the relationship between risk factors (exposures) and outcomes without intervening.

What is the hierarchy of evidence from highest to lowest?

Meta-analysis & Systematic Reviews, Randomized Controlled Trials, Cohort Studies, Case-Control Studies, Case Series, Case Reports, Editorials, Expert Opinion.

What is the aim of a cross-sectional study?

To describe a population or a subgroup within the population with respect to an outcome and a set of risk factors.

What characterizes a cohort study?

A group is studied over time, measuring particular baseline characteristics or exposures related to outcomes.

What is the purpose of case-control studies?

To compare a ‘case’ group of patients who have the outcome of interest with a ‘control’ group without the outcome.

What is an ecological study?

A study where at least one variable is measured at the group level, used to examine relationships between exposures and outcomes.

What do clinical trials seek to investigate?

They compare different treatments or treatment strategies to test whether one is better than another.

What is the primary focus of Phase III trials?

To assess how well a new treatment works and to obtain regulatory approval for new treatments.

What are the characteristics of a 'good' clinical trial?

The use of a control group, randomisation, blinding (when appropriate), and a large enough sample size.

What is randomisation in clinical trials?

The allocation of treatment between groups at random to protect against selection bias.

What does blinding or masking in a clinical trial aim to minimize?

Observer bias.

Why is it important for a clinical trial to have an adequate sample size?

To ensure it has the statistical power to detect clinically important differences between treatment groups.

What outcomes can a clinical trial find regarding a new treatment or device?

It may improve patient outcomes, offer no benefit, or cause unexpected harm.

What is the significance of Phase IV trials?

They gather information on a drug's effect in various populations and any side effects associated with long-term use.

What is the structure of the assessment for this module?

30 question Multiple-Choice Questionnaire (25% weighting) and a 15-minute group presentation (75% weighting).