Contemporary clinical trials
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Contemp Clin Trials · Jul 2012
ReviewEarly phase drug development for treatment of chronic pain--options for clinical trial and program design.
Due to high prevalence and unmet medical need, chronic pain has become an important area for development of new medicines. Chronic pain disorders are heterogeneous with regard to pathophysiological mechanisms and clinical presentation. While a mechanism-based classification of pain is generally advocated, it is not yet applicable for diagnostic use. ⋯ We have reviewed characteristics of three alternative design options from an early (Phase 2) drug development perspective; enriched enrolment, dose titration and adaptive dosing. The advantages and disadvantages of each type of study design were analyzed and discussed from a clinical development program perspective. It is concluded that these designs can be useful in addressing different types of issues in early development of novel analgesic drugs for chronic pain.