Improving Assay Sensitivity In Phase 3 Trials: Existing Data - immpact

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Some recent findings on placebo effects inneuropathic pain clinical trials1. Negative trials show greater improvement in theplacebo groups• Katz J, Finnerup NB, Dworkin RH. Clinical trial outcome in neuropathic pain:relationship to study characteristics. Neurology, 2008;70:263-272.2. Placebo group response appears to be greater thelonger the trial (painful DPN)• Quessy SN, Rowbotham MC. Placebo response in neuropathic pain trials. Pain,2008;138:479-483.3. Placebo group response, but not active treatment groupresponse, is significantly greater in painful DPNcompared with PHN trials.• Dworkin RH. Turk DC, Peirce-Sandner S, McDermott MP, Farrar JT, Hertz S,Katz NP, Raja SN, Rappaport BA. Placebo and treatment group responses inpostherpetic neuralgia vs. painful diabetic peripheral neuropathy clinical trialsin the REPORT database. Pain, 2010;150:12-16.
1. Understand relationships between studymethodological features and assaysensitivity.• perhaps especially placebo groupimprovement2. Modify study methodological features toincrease assay sensitivity.• include efforts to reduce placebogroup improvement (?)
Page 1 and 2: Improving assaysensitivity in Phase
Page 4 and 5: 16 additional recent “negative”
Page 6 and 7: “Insanity: doing the samething ov
Page 10 and 11: What approaches can be used tooptim
Page 12 and 13: Patient factors that may be associa
Page 14 and 15: “Individuals with a greater PVI (
Page 17 and 18: “...Though it is natural to hope
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Page 22: Can Phase 3 trials continue to excl

Improving Assay Sensitivity In Phase 3 Trials: Existing Data - immpact

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