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

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<strong>In</strong>vestigator factors that may be associatedwith increased assay sensitivity1. Greater experience and training for study staff2. Fewer and more structured contacts betweenstudy staff and patients• but would this increase the number ofpatients withdrawing from the trial?3. To the greatest extent possible, blindinvestigators and study staff to the protocol.4. Reduce financial incentives and other methodsused to accelerate enrollment
Research design factors1. Duration of trial: as short as possible (but would a 2-weekbaseline provide a better patient assessment?)2. Fewer treatment arms3. Flexible vs. fixed dosage designs4. Role of concomitant analgesics5. Better reliability, validity, and, especially, responsivenessof outcome measures6. Composite (vs. unidimensional) outcome measures,for example, OMERACT-OARSI responder index7. More attention is needed to actual methods ofadministration of the outcome measures15. Geographic region (e.g., North America and WesternEurope vs. elsewhere?)
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 8 and 9: Some recent findings on placebo eff
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
Page 22: Can Phase 3 trials continue to excl

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

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