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

 

Chapter 1: Clinical Trials of Pain Treatment: Dose-Response; Relative Potency; Combinations

 
         

What is the most appropriate way to compute the average time of onset of pain relief and statistically compare the drug group to the placebo group?

You answered:Selection A

Calculate the mean times to onset and compare the means for the drug and placebo groups using an unpaired t test.

INCORRECT

Most pain researchers continue to use means to represent the magnitude of pain reduction because the distribution of pain scores usually approaches normality and this analysis has the most power. For the analysis of time of analgesic onset, however, the work of (Laska et al., 1991) has generated a consensus that a group of nonparametric techniques called "survival analyses" are most appropriate. In these methods, adapted from the analysis of long-term cancer and cardiovascular disease trials, the median and 25th and 75th percentile scores are used to represent the group result. Such analysis of analgesic onset and duration is now done routinely in single-dose studies of new drugs (Ganju et al., 1999). The same principles are applicable to chronic treatment of any disease (Laska and Siegel, 1995), but have not yet been adopted in chronic analgesic studies.

 

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