Randomised controlled trials

Randomized controlled trials The Basics

Definition ,[object Object],[object Object]

[object Object],[object Object]

Schema of a simple trial Eligible patients Rx group 1 Rx group 2 Randomize

Why Randomize? ,[object Object],[object Object],[object Object],[object Object],[object Object]

RCT ,[object Object],[object Object],[object Object],[object Object]

What is wrong with non-randomized studies? ,[object Object]

Non-randomized studies II ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Non-randomized studies III ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Random allocation ,[object Object],[object Object]

Is coin tossing OK? ,[object Object],[object Object]

Example: trial with 30 patients ,[object Object],[object Object],[object Object],[object Object],[object Object]

But we need randomization ,[object Object],[object Object],[object Object]

Pseudo-randomisation ,[object Object],[object Object],[object Object],[object Object]

True randomization ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Value of randomization ,[object Object]

Types of RCTs ,[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object]

Blinding ,[object Object],[object Object],[object Object]

Blinding is difficult ,[object Object],[object Object],[object Object],[object Object]

Follow up ,[object Object],[object Object],[object Object]

Analysis of clinical trials Analysis of clinical trials Intension to treat analysis Per protocol analysis Sub group analysis

Disadvantages of RCTs ,[object Object],[object Object],[object Object]

Interim Analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

RCTs ,[object Object],[object Object],[object Object]

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