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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

 
           

Question 6.1.3

The drug company follows your advice in the previous question to do an extended double-blind pilot study comparing Drug P to placebo over a 6 week period. Patients rate "pain over the past 24 hours" on a 0-10 numerical scale, and "baseline pain" is defined as the mean of the pain scores for the 7 days before randomization. You arbitrarily define the "time of onset" as the earliest time point at which pain has been reduced to 50% or less of the baseline pain score for three consecutive days.

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?

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

Selection B

Calculate the median time to onset and compare the overall distributions of the onset times using survival analysis techniques.

 

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