Clinical Trials Hanyan Yang [email protected] 2008.12. Treatment. Once the nature of a patient’s illness has been established and its expected, the next question is: what can be done about it? Is there a treatment that improves the outcome of disease?
A clinical trial is a prospective study comparing the effect and value of intervention(s) against a control in human beings.
A special kind of cohort study in which the conditions of study ---selection of treatment groups, nature of intervention, management during follow-up,etc.---are specified by the investigator for the purpose of making unbiased comparison.
OutcomeGeneral Design of Clinical Trial
PAR = Population at Risk
S = Sampling design
R = Randomize intervention
T = Elapsed time
Randomization will, on average, balance the known and unknown risk factors for the outcome under study.
Efficacy = 1 -
= 1 - Relative Risk
IncidenceplaceboClinical Trials: Analysis