Table 1.

Criteria for Effectiveness Based on Substantial Evidence from Adequate and Well-Controlled Trials

Criteria
Clear objective of the study
Study allows a quantitative comparison with a control group
Appropriate selection of participants with the disease in treatment trials or at risk of disease in prevention trials
Baseline comparability between study groups
Minimizing bias
Well-defined and reliable outcome measures
Appropriate analysis of results

NOTE. Evidence of effectiveness must be balanced against potential harms to obtain overall evaluation of risk-benefit.