Clinical study methodology ensures a well-designed study, which in turn ensures the validity and reliability of the study:
• The hypothesis is the question or supposition that is the starting place for all
clinical research
• Endpoints are the specific results that help to prove or disprove the hypothesis
• Study design ensures that the results of the study are due to the specific treatment or intervention being studied
• The Methods section of a clinical study describes how the study was performed, who was studied, what parameters were measured, and how the data were analyzed
• The Results section of a study presents the findings of the study in an unbiased, straightforward format