Nucleotide Synthesis Inhibitors.ppt

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Nucleotide Synthesis Inhibitors

Outcomes in Randomized Controlled Trials in Pain: A Proposed Responder Analysis Vibeke Strand, MD Biopharmaceutical Consultant Clinical Professor, Division of Immunology, Stanford University Responder Analyses have Face and Content Validity Allow assessment of multiple domains Could better categorize analgesics Facilitate comparison of efficacy across: Products Heterogeneous populations, and Multiple disease indications May lead to tiered approach to label indications Precedent: ACR Responder Index in RA ACR Response Criteria used in RA RCTs Require ≥20% improvement in 5 of 7 measures: Tender Joint Count and Swollen Joint Count and 3 of the following 5: MD Global Physical function: HAQ Pain by VAS Patient Global ESR and/or CRP Strength of Rheumatoid Arthritis Guidance Document Tricenter agreement; Proven track record ? 6 products! Tiered Label Indications: Improvement in Signs and Symptoms By ACR Response Criteria At 6 or 12 months Inhibition of Radiographic Progression Sharp Scores [erosions + JSN] At 12 months Improvement in physical function and HRQOL HAQ and SF-36 Over 2-5 years May be achieved in a single protocol using prespecified outcome criteria and Hochberg analysis Appropriate Domains for Inclusion in RCTs in Chronic Pain Based on a Breakout Session at the Jointly Sponsored FDA / NIH Workshop in May 2002 Definition for the Workshop: RCTs of ≥ 3 months duration; In patients with pain of 3 months duration, regardless of underlying cause Examples of Chronic Pain Indications Musculoskeletal RA OA Low Back Pain Fibromyalgia Neuropathic Diabetic Neuropathy Post Herpetic Neuralgia Trigeminal Neuropathy Cancer Pain [not necessarily 3 months] Rapidly progressive disease Adjust intervention as disease progresses Proposed Domains for Chronic Pain To Be Selected: Regardless of clinical indication Consider available instruments; whether or not Validated in pain or specific clinical indications Previously used in RCTs in Pain Disease s

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