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
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