Central endoscopy reads in inflammatory bowel disease clinical trials: The role of the imaging core lab

Gastroenterology Report

Volumn 2, Issue 3, 2014, Pages 201-206

  Ahmad, Harris ^a   Berzin, Tyler M ^b   Yu, Hui Jing ^a   Huang, Christopher S ^c   Mishkin, Daniel S ^d  

^a BioClinica Inc   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d BOSTON MEDICAL CENTER   (United States)

Author keywords

Clinical trials; Imaging core laboratories; Inflammatory bowel disease

Indexed keywords

EID: 84908069001     PISSN: None     EISSN: 20520034     Source Type: Journal    
DOI: 10.1093/gastro/gou033     Document Type: Review

References (28)

1. Cooney R, Warren B, Altman D et al. Outcome measurement in clinical trials for ulcerative colitis: towards standardisation. Trials 2007;8:17.
2. D'Haens G, Sandborn WJ, Feagan BG et al. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology 2007;132:763-86.
3. Travis SPL, Schnell D, Krzeski P et al. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Gut 2012;61:535-42.
4. Feagan BG, Sandborn WJ, D'Haens G et al. The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Gastroenterology 2013;145:149-57.e2.
5. Feagan BG and MacDonald JK. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev 2012;10:CD000543.
6. Food and Drug Administration. Guidance for Industry: Standards for Clinical Trial Imaging Endpoints. http://www.fda.gov/downloads/Drugs/Guidance-Compliance-Regulatory-Information/Guidances/UCM268555.pdf. 2011. Last accessed June 9, 2014.
7. Amit O, Bushnell W, Dodd L et al. Blinded independent central review of the progression-free survival endpoint. Oncologist 2010; 15:492-5.
8. Dancey JE, Dodd LE, Ford R et al. Recommendations for the assessment of progression in randomised cancer treatment trials. Eur J Cancer 2009;45:281-9.
9. Dodd LE, Korn EL, Freidlin B et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol 2008;26:3791-6.
10. Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-47.
11. Ford R, Schwartz L, Dancey J et al. Lessons learned from independent central review. Eur J Cancer 2009;45:268-74.
12. Sargent DJ, Rubinstein L, Schwartz L et al. Validation of novel imaging methodologies for use as cancer clinical trial end-points. Eur J Cancer 2009;45:290-9.
13. European Medicines Agency. Guideline on clinical investigation of medicinal products other than NSAIDs for treatment of rheumatoid arthritis. http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2011/12/WC500119785.pdf. 2011. 2011. Last accessed June 9, 2014.
14. Navarro-Compan V, Landewe R, Ahmad HA et al. Rate of adjudication of radiological progression in rheumatoid arthritis randomized controlled trials depending on preset limits of agreement: a pooled analysis from 15 randomized trials. Rheumatology (Oxford) 2013;52:1404-7.
15. Chawla S, Henshaw R, Seeger L et al. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol 2013;14:901-8.
16. Chung KY, Shia J, Kemeny NE et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol 2005; 23:1803-10.
17. Graffagnino C, Bergese S, Love J et al. Clevidipine rapidly and safely reduces blood pressure in acute intracerebral hemorrhage: the ACCELERATE trial. Cerebrovasc Dis 2013;36: 173-80.
18. Kondagunta GV, Drucker B, Schwartz L et al. Phase II trial of bortezomib for patients with advanced renal cell carcinoma. J Clin Oncol 2004;22:3720-5.
19. Miller VA, Hirsh V, Cadranel J et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol 2012;13:528-38.
20. Takeuchi T, Harigai M, Tanaka Y et al. Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. Ann Rheum Dis 2013;72:1488-95.
21. Ward LM, Rauch F, Whyte MP et al. Alendronate for the treatment of pediatric osteogenesis imperfecta: a randomized placebocontrolled study. J Clin Endocrinol Metab 2011;96:355-64.
22. Baron JH, Connell AM and Lennard-Jones JE. Variation between observers in describing mucosal appearances in proctocolitis. Br Med J 1964;1:89-92.
23. Daperno M, D'Haens G, Van Assche G et al. Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CD. Gastrointest Endosc 2004;60:505-12.
24. Mary JY and Modigliani R. Development and validation of an endoscopic index of the severity for Crohn's disease: a prospective multicentre study. Groupe d'Etudes Therapeutiques des Affections Inflammatoires du Tube Digestif (GETAID). Gut 1989;30:983-9.
25. Truelove SC and Witts LJ. Cortisone in ulcerative colitis; final report on a therapeutic trial. Br Med J 1955;2:1041-8.
26. Schroeder KW, Tremaine WJ and Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 1987;317: 1625-9.
27. European Medicines Agency. Guideline on the development of new medicinal products for the treatment of Crohn's disease. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2012/10/WC500134469.pdf 2008. Last accessed June 9, 2014.
28. European Medicines Agency. Guideline on the development of new medicinal products for the treatment of ulcerative colitis. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2012/10/WC500134469.pdf. 2008. Last accessed June 9, 2014.