Report from the NEI/FDA ophthalmic clinical trial design and endpoints symposium

被引：187
|
作者：
Csaky, Karl G. [1 ]
Richman, Elaine A. [2 ]
Ferris, Frederick L., III [3 ]
机构：
[1] Duke Univ, Med Ctr, Ophthalm Unit, DCRI, Durham, NC 27710 USA
[2] Richman Associates LLC, Baltimore, MD USA
[3] NEI, NIH, Div Epidemiol & Clin Res, Bethesda, MD 20892 USA
来源：
INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE | 2008年 / 49卷 / 02期
关键词：
D O I：
10.1167/iovs.07-1132
中图分类号：
R77 [眼科学];
学科分类号：
100212 ;
摘要：
引用
收藏
页码：479 / 489
页数：11
相关论文
共 50 条
  • [21] Evolution and optimization of clinical trial endpoints and design in pulmonary arterial hypertension
    Caccamo, Marco
    Harrell, Frank E. E.
    Hemnes, Anna R. R.
    PULMONARY CIRCULATION, 2023, 13 (03)
  • [22] Clinical Trial Design and Endpoints for Stage IV Melanoma in the Modern Era
    Izar, Benjamin
    Regan, Meredith M.
    McDermott, David F.
    CANCER JOURNAL, 2017, 23 (01): : 63 - 67
  • [23] Review of Acute Treatment of Migraine Trial Results With the New FDA Endpoints: Design Implications for Future Trials
    Hindiyeh, Nada A.
    Kellerman, Donald J.
    Schmidt, Peter C.
    HEADACHE, 2019, 59 (05): : 819 - 824
  • [24] US FDA draft Guidance Standard for Clinical Trial Imaging Endpoints: more than just imaging?
    Walovitch, Richard C.
    Chokron, Patrick
    Agarwal, Sheela
    BIOMARKERS IN MEDICINE, 2012, 6 (06) : 839 - 847
  • [25] SENSITIVITY OF CLINICAL ENDPOINTS IN THE ASCO ONCOLOGY VALUE FRAMEWORK AND IMPLICATIONS FOR CLINICAL TRIAL DESIGN
    Chawla, A. S.
    Wood, B.
    Myrick, S.
    Smith, G.
    Chawla, V
    Doyle, J. J.
    VALUE IN HEALTH, 2016, 19 (03) : A76 - A76
  • [26] Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium
    Fangusaro, Jason
    Avery, Robert A.
    Fisher, Michael J.
    Packer, Roger J.
    Walsh, Karin S.
    Schouten-van Meeteren, Antoinette
    Karres, Dominik
    Bradford, Diana
    Bhatnagar, Vishal
    Singh, Harpreet
    Kluetz, Paul G.
    Donoghue, Martha
    Duke, Elizabeth S.
    CLINICAL CANCER RESEARCH, 2024, 30 (11) : 2303 - 2308
  • [27] Novel trial design: A report from the 19th Frontiers Symposium of ACCP
    Ameer, Barbara
    JOURNAL OF CLINICAL PHARMACOLOGY, 2008, 48 (07): : 793 - 798
  • [28] The A-Z of Clinical Trials - Clinical Trial Design Incorporating Efficacy, Translational and Biomarker Endpoints
    Eisenhauer, E. A.
    EUROPEAN JOURNAL OF CANCER, 2012, 48 : S20 - S20
  • [29] FUTURE CLINICAL TRIAL DESIGN AND THE USE OF BIOLOGIC ENDPOINTS AND AGENTS IN RADIATION ONCOLOGY
    Corvo, R.
    RADIOTHERAPY AND ONCOLOGY, 2008, 88 : S9 - S9
  • [30] Positive Impact of Revised FDA Guidance on Clinical Trial Design in Diabetes
    Bethel, M. Angelyn
    Sourij, Harald
    DIABETES, 2012, 61 : A264 - A265
12345