Test Yourself

When planning your experiment you need to consider how the statistical analysis will be performed.

In designing a clinical trial it is important to ensure that the patients most likely to respond favourably are recruited into the treatment arm.

If a drug has been in use for many years and a doctor wishes to use this drug for a new indication in a UK clinical trial it is not necessary to seek ethical approval.

A phase 2 clinical trial assesses efficacy and safety in limited numbers of closely monitored patients.   

Phase 3 clinical trials may use both controlled and uncontrolled studies to assess efficacy for specific indications and drug-related adverse effects in larger numbers.   

A phase 4 clinical trial provides post-marketing research for specific pharmacological effects and long-term safety.   

Inadequate patient information is the single most usual reason to fail to gain ethical approval for a clinical trial.