Decade-long profile of imaging biomarker use in ophthalmic clinical trials

Investigative Ophthalmology and Visual Science

Volumn 58, Issue 6, 2017, Pages BIO76-BIO81

  Villani, Edoardo ^a   Massaro, Domenico ^a   Scaramuzzi, Matteo ^a   Hamrah, Pedram ^b   Medeiros, Felipe A ^c   Nucci, Paolo ^a  

^a UNIVERSITY OF MILAN   (Italy)

^b TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Biomarker; Clinical trials; Imaging; Ophthalmic research; Surrogate endpoint

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; AUTOFLUORESCENCE; CORNEA; DIAGNOSTIC IMAGING; DOPPLER FLOWMETRY; FLUORESCENCE ANGIOGRAPHY; GLAUCOMA; HUMAN; INSTRUMENT VALIDATION; MACULAR THICKNESS; OPHTHALMOLOGY; OPTICAL COHERENCE TOMOGRAPHY; PATIENT SELECTION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PREVALENCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETINA; STRATIFICATION; VALIDATION PROCESS; BIOASSAY; CLINICAL TRIAL (TOPIC); EYE DISEASES; FORECASTING; PROCEDURES; PROGNOSIS; TRENDS; VISUAL SYSTEM EXAMINATION;

CLINICAL TRIALS AS TOPIC; DIAGNOSTIC TECHNIQUES, OPHTHALMOLOGICAL; ENDPOINT DETERMINATION; EYE DISEASES; FORECASTING; HUMANS; OPHTHALMOLOGY; PROGNOSIS;

EID: 85019864691     PISSN: 01460404     EISSN: 15525783     Source Type: Journal    
DOI: 10.1167/iovs.17-21790     Document Type: Article

References (29)

1. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69:89–95.
2. U.S. Department of Health and Human Services. Innovation/ Stagnation: Challenges and Opportunities on the Critical Path to New Medical Products. Available at: http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM113411.pdf. Accessed January 5, 2017.
3. Robb MA, McInnes PM, Califf RM. Biomarkers and surrogate endpoints: developing common terminology and definitions. JAMA. 2016;315:1107–1108.
4. Amur S, LaVange L, Zineh I, Buckman-Garner S, Woodcock J. Biomarker qualification: toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization. Clin Pharmacol Ther. 2015;98:34–46.
5. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Available at: http://www.ncbi.nlm.nih.gov/books/NBK326791/. Accessed February 14, 2017.
6. Wagner JA, Atkinson AJ Jr. Measuring biomarker progress. Clin Pharmacol Ther. 2015;98:2–5.
7. Medeiros FA. Biomarkers and surrogate endpoints in glaucoma clinical trials. Br J Ophthalmol. 2015;99:599–603.
8. Mankoff DA, Farwell MD, Clark AS, Pryma DA. How imaging can impact clinical trial design: molecular imaging as a biomarker for targeted cancer therapy. Cancer J. 2015;21: 218–224.
9. Eckstein F, Guermazi A, Gold G, et al. Imaging of cartilage and bone: promises and pitfalls in clinical trials of osteoarthritis. Osteoarthr Cartil. 2014;22:1516–1532.
10. Razzouk L, Farkouh ME. Imaging outcomes in cardiovascular clinical trials. Nat Rev Cardiol. 2009;6:524–531.
11. U.S. Department of Health and Human Services. Clinical Trial Imaging Endpoint Process Standards: Guidance for Industry. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm268555.pdf. Accessed February 14, 2017.
12. Ilginis T, Clarke J, Patel PJ. Ophthalmic imaging. Br Med Bull. 2014;111:77–88.
13. Kao LS, Tyson JE, Blakely ML, Lally KP. Clinical research methodology I: introduction to randomized trials. JAmColl Surg. 2008;206:361–369.
14. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.
15. Journal Citation Report. Thomson Reuters website. Available at: http://admin-apps.webofknowledge.com.pros.lib.unimi.it/JCR/JCR. Accessed February 14, 2017.
16. Moradian S, Faghihi H, Sadeghi B, et al. Intravitreal bevacizumab vs. sham treatment in acute branch retinal vein occlusion with macular edema: results at 3 months (report 1). Graefes Arch Clin Exp Ophthalmol. 2011;249:193–200.
17. Jaffe GJ, Schmitz-Valckenberg S, Boyer D, et al. Randomized trial to evaluate tandospirone in geographic atrophy secondary to age-related macular degeneration: the GATE study. Am J Ophthalmol. 2015;160:1226–1234.
18. Alm A, Grunden JW, Kwok KK. Five-year, multicenter safety study of fixed-combination latanoprost/timolol (Xalacom) for open-angle glaucoma and ocular hypertension. J Glaucoma. 2011;20:215–222.
19. Lee JW, Devanarayan V, Barrett YC, et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res. 2006;23:312–328.
20. Danis RP. The clinical site-reading center partnership in clinical trials. Am J Ophthalmol. 2009;148:815–817.
21. Weintraub WS, Lüscher TF, Pocock S. The perils of surrogate endpoints. Eur Heart J. 2015;36:2212–2218.
22. Razzouk L, Farkouh ME. Imaging outcomes in cardiovascular clinical trials. Nat Rev Cardiol. 2009;6:524–531.
23. Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2:e124.
24. Fujimoto J, Swanson E. The development, commercialization, and impact of optical coherence tomography. Invest Ophthalmol Vis Sci. 2016;57:OCT1–OCT13.
25. Rosenfeld PJ. Optical coherence tomography and the development of antiangiogenic therapies in neovascular agerelated macular degeneration. Invest Ophthalmol Vis Sci. 2016;57:OCT14–OCT26.
26. Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012;11:MR000030.
27. Yao AC, Khajuria A, Camm CF, Edison E, Agha R. The reporting quality of parallel randomised controlled trials in ophthalmic surgery in 2011: a systematic review. Eye (Lond). 2014;28:1341–1349.
28. Lai TY, Wong VW, Lam RF, Cheng AC, Lam DS, Leung GM. Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals. Ophthalmic Epidemiol. 2007;14:390–398.
29. Farwell MD, Clark AS, Mankoff DA. How imaging biomarkers can inform clinical trials and clinical practice in the era of targeted cancer therapy. JAMA Oncol. 2015;1:421–422.