Abstract：
:A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated. Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ("assay sensitivity"). Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development. Therefore, an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was reviewed and discussed. On the basis of this meeting and subsequent discussions, the authors recommend consideration of a number of patient, study design, study site, and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments. Increased attention to and research on methodological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence-based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety.
journal_name
Painjournal_title
Painauthors
Dworkin RH,Turk DC,Peirce-Sandner S,Burke LB,Farrar JT,Gilron I,Jensen MP,Katz NP,Raja SN,Rappaport BA,Rowbotham MC,Backonja MM,Baron R,Bellamy N,Bhagwagar Z,Costello A,Cowan P,Fang WC,Hertz S,Jay GW,Junor R,Kerdoi
10.1016/j.pain.2012.03.003subject
Has Abstractpub_date
2012-06-01 00:00:00pages
1148-1158issue
6eissn
0304-3959issn
1872-6623pii
00006396-201206000-00009journal_volume
153pub_type
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