Common types of clinical trial design, study objectives ...

Common types of clinical trial design, study objectives, randomisation and blinding, hypothesis testing, p-values and confidence intervals, sample size calculation

David Brown

Statistics

? Statistics looks at design and analysis ? Our exercise noted an example of a flawed design

(single sample, uncontrolled, biased population selection, regression to the mean) ? And statistical theory can be used to understand the reason for the results ? Not a completely outrageous example

Case study

? Primary endpoint ? recurrence rate post-treatment compared with historical rates observed 1-year pre-treatment

? Inclusion criteria include requirement that patient must have been treated for uveitis within the last 3 months

Results

Recurrence rates

pre-implantation (1-year) 34 weeks 1-year 2-years 3-years

Same problems here

(n=110) 68 (62%) 2 (2%) 4 (4%) 11 (10%) 33 (30%)

(n=168) 98 (58%) 8 (5%) 11 (7%) 28 (17%) 80 (48%)

Uncontrolled blood pressure trial could be similar ? inclusion criteria usually require a high value

Clinical Trials

? Prospective experiments in medical treatments

? Designed to test a hypothesis about a treatment ? Testing of new drugs ? Testing old drugs in new indications ? Testing of new procedures

Comparison of randomised groups

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download