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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

 
           

There are several advantages in using these relative potency designs that directly compare a range of doses of two preparations. (Beaver et al., 1968; Laska et al., 1984). First, the resulting relative potency estimates allow clinicians to estimate the dose of a new drug in the individual patient based on the previous dose of the standard analgesic usually used by that patient. Additionally, if one quantitates specific side effects along with each pain measurement, relative potency studies allow one to test whether a new analgesic or drug combination is less toxic than the standard (Figure 6.3.1); the relative intensity of adverse effects can be estimated for the two treatments at doses providing the same analgesia.

There are also pitfalls in interpreting single-dose relative potency assays. The approach assumes that the effect ranges studied in the two dose-response curves overlap, and that they are linear and parallel, as in panel A. If the dose-response curves are not parallel (C) or linearl (D) or if the doses chosen are not in the same analgesic range (B)Æ the calculated relative potency (denoted by Æ in the figure) is meaningless (Figure 6.3.2).

Graphic depiction of single-dose relative potency assays, described in text.

In addition, if the drugs to be compared have different kinetics, the relative potency may vary greatly depending upon whether the peak pain relief or the summed scores over time are used. For example, using summed scores over time will favor a drug with longer duration (Figure 6.3.3).

Click on image to enlarge

Figure 6.3.3a
Figure 6.3.3b
Graphic depiction of four point relative potency study, described in text.
Four-point relative potency study comparing intramuscular (filled circles) and oral (open circles) phenazocine. (a) Pain intensity difference (category scale) is plotted against time (left). Note the difference between the time course of analgesia for the two routes. (b) total (left) or peak (right) change in pain intensity are plotted against dose. For total scores, oral phenazocine is one-fourth as potent as seen with the two routes. Because the time-course of response differs between the routes, note that the relative potency calculated for total scores will change according to the length of the study; e.g. if only the first three hours were considered, the infranuscular/oral disparity would have appeared even greater. Beaver et al., (1968) with permission.
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