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Trial Design: Pain Sections
Author Bio
Introduction
Placebo Effects
Currently selected section: Single Dose Trials
Repeated Dose Trials
Explanatory Versus Pragmatic
Dose-Response
Parallel Group Versus Crossover
Conclusion
 

 

Chapter 1: Clinical Trials of Pain Treatment: Single Dose Trials: Question 3.3
        

What can you conclude from these data?

You answered:

Selection BThe result is inconclusive. One possibility is that Drug X is ineffective in this condition. An alternative possibility is that although Drug X would usually be effective in this condition, the methods of this particular study were flawed and therefore the study lacked "assay sensitivity."

Treatments were placebo and Drug X.  The figure shows that both of these treatments gave a modest amount of pain relief, less than one standard error different from each other.

CORRECT

A finding of "no significant differences" is equivocal in a symptom study. The absence of a difference may reflect that the drug is truly ineffective or alternatively, that the study lacked sensitivity to demonstrate an effect.

Even if Drug X is truly analgesic, the assay may have been insensitive because patients had pain too severe to respond to the analgesic, the pain questionnaires were confusing, or the procedures of the nurse-observer inconstant. A final possibility is that the finding of no difference may have been a false negative due to random variation.

 

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