Does a very large randomized clinical trial guarantee an inherently good trial?
The quality of a very large clinical trial is dependent on having a well constructed treatment protocol to the same degree that a smaller trial is dependent on this issue. If one or both of the treatment arms of a clinical trial has serious limitations in regards to representing optimal therapy for a particular strategy being evaluated, then the clinical applicability of the results to patient care is less directly meaningful. (example) Hence, a very large trial is dependent on the quality of the treatment protocol in regards to the clinical applicability of the trial for physicians managing and treating similar patients. Validity of Conclusion of Large Randomized Clinical Trials The conclusions that the authors of a very large randomized trial derive from their results are subject to the same potential for author bias as the conclusions that are made in a small study. The authors of both types of studies give an opinion on the strengths and limitations of the study protocol as well as
