5. 新藥開發流程 Scale-up 臨床前研究 臨床試驗 新藥審核 12-24 months 1-4 month 9-12 months 12-24 months 6-18 months Phase II Phase IV Pharmacology and Pharmacokinetics Animal Safety Testing Submit IND Submit NDA NDA Approval Formulation Chemistry and Physical Characterization Phase III 新藥監視 Botanicals with historical documentation of safe human use
32. ATTAIN study abatacept in inadequate responders to TNF-targeted therapy Day 1 12 months 24 months Randomization Placebo + DMARD (n=133) Fixed-dose abatacept ~10 mg/kg + DMARD (n=258) Randomization=2:1 Anti-TNF inadequate responders with active disease (n=393)* Co-primary endpoints: ACR 20 and Physical Function Fixed-dose abatacept ~10 mg/kg † + DMARD (n=317) ‡ Double-blind Open-label phase 6 months Open label phase ongoing *DMARDs continued, antiTNF washout period (28–60 days); † Based on patient weight range; ‡ Patients randomized to the placebo group in the first 6 months switched to abatacept during OL period; LTE=long-term extension Genovese M, et al. N Engl J Med 2005;353:1114–1123
33.
34. Crossover Clinical Trial Drug B Drug A W A S H O U T Phase 1 Period Eligible Patients /subjects Drug A Drug B Informed consent Drug B Drug A Phase 2
43. Comparing Means for Two Independent Samples http://stat.ubc.ca/~rollin/stats/ssize/
44.
45.
46. Data Management Process CRF CRF 資料接收簽收單 資料確認表格 CRA CDM 臨床統計師 CRF 資料建檔確認表格 資料確認表格簽收單 Data lock Data entry Data entry: 合併校正 Data validation Data analysis
47.
48.
49.
50.
51.
52. Contact us: CSMUH Chinese Medicine Clinical Trial Center http://www.csh.org.tw/into/herb James Cheng-Chung Wei, MD, PhD ( 魏正宗 ) [email_address]
Notes de l'éditeur
This slide shows a schematic overview over the study design. There will be a 6-month short-term period followed by the open-label long term extension which continues until abatacept SC is commercially available in the country or until BMS elects to terminate the trial. In short-term, 50% of the subjects (720) will get randomized to the Abatacept SC arm, while the other half of the subjects will get randomized to the abatacept IV arm. Therefore, all patients receive active drug irrespective of the study arm, and the majority of subjects will receive the new route of administration, Abatacept SC. Patients, who continue in the long-term extension, will administer weekly abatacept injections only, which is then provided as open-label study drug.
![臨床試驗計畫書 Protocol ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)