1) Phases of a Clinical Trial

What is the main goal of a Phase 3 clinical trial?

To evaluate the treatment's effectiveness in a large patient population

hy is randomisation critical in a randomised controlled trial?

It makes the groups comparable by evenly distributing characteristics

What is the purpose of Phase 1 trials?

To evaluate how the drug is processed and assess basic safety in healthy individuals

What was the unintended consequence of Dr. Spock’s sleeping advice for infants?

It significantly raised the risk of sudden infant death syndrome

What is the main advantage of blinding in clinical trials?

It minimizes conscious and unconscious bias in reporting and measurement

Why are surrogate outcomes often problematic in trials?

They often fail to correlate with patient-centered outcomes like quality of life

What is the issue with outcome switching in clinical trials?

It exaggerates treatment effects and undermines scientific validity

What is stratified randomisation used for in clinical trials?

To ensure equal numbers of participants with key characteristics across groups

What does an intention-to-treat analysis involve?

Including all participants as originally assigned, even if they drop out

Why is defining inclusion and exclusion criteria important in trial design?

To ensure the sample reflects the target treatment population

What does double-blinding typically involve?

Neither patients nor outcome assessors know the group allocations

Why is a larger sample size generally preferred in trials?

It increases the chance of detecting significant effects and reduces random error

Why are randomised controlled trials considered the backbone of medical evaluation?

They provide rigorous comparisons between intervention and control groups