MEDC0014 – Introduction to Clinical Trials

Flashcards covering vocabulary from the Introduction to Clinical Trials lecture.

Clinical Study

Research using human volunteers (participants) that is intended to add to medical knowledge.

Interventional Study

A study where the investigator tests whether giving the study participants some kind of intervention alters the development, or the course, of an outcome.

Observational Study

A study where investigators observe the course of a disease or the relationship between risk factors (exposures) and outcomes without intervening or manipulating the situation.

Cross-sectional Study

A study that aims to describe a population or a subgroup within the population with respect to an outcome and a set of risk factors at a fixed point in time.

Cohort Study

A study where a group of subjects, selected to represent the population of interest, is studied over time to compare the incidence of an outcome in exposed individuals with those not exposed.

Case-control Study

A study that selects a ‘case’ group of patients with the outcome of interest and a ‘control’ group without the outcome, then compares the proportions with the exposure of interest in each group.

Ecological Study

A study in which at least one variable is measured at the group level to examine the relationship between disease rates and exposures in different populations.

Clinical Trial

A type of interventional study where the investigator intervenes to prevent or change the course of an outcome, comparing different treatments or treatment strategies.

Randomised Controlled Trial

The gold standard for evaluation of an intervention, involving random allocation of treatment between groups to avoid selection bias.

Bias

A tendency of an estimate to deviate in one direction from a true value, potentially leading to systematic underestimation or overestimation of intervention effects.

Phase I Trials

First-in-human studies involving healthy volunteers or patients who have tried and failed on existing standard treatment, primarily focused on safety.

Phase II Trials

Tests of a new treatment in a larger group of people with the condition for which the treatment is to be used, aiming to see if the treatment is safe and if it has any biological activity or effect.

Phase III Trials

Involve larger numbers of patients, randomised to receive the new treatment or the best available current treatment (or a placebo), focusing on efficacy or effectiveness and continuing to look at safety.

Phase IV Trials

Carried out after a drug has already been approved by regulatory authorities, to gather information on a drug's effect in various populations and any side effects associated with long-term use.

Control Group

A group of clinical trial participants who do not receive the treatment being investigated, serving as a standard or baseline for comparison.

Randomisation

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

Blinding/Masking

A process where patients and/or doctors do not know which treatment a patient is receiving, to minimise observer bias.

Sample Size

The number of people taking part in a trial; needs to be large enough to detect clinically important differences between treatment groups.