Design and conduct of clinical trials: Report of the clinical trials subcommittee of the international Dry Eye WorkShop (2007)

被引：0

作者：

Tsubota, Kazuo ^{[1
]}

Asbell, Penny ^{[1
]}

Dogru, Murat ^{[1
]}

Form, Desmond ^{[1
]}

Foulks, Gary ^{[1
]}

Schaumberg, Debra ^{[1
]}

Schein, Oliver ^{[1
]}

Watanabe, Hitoshi ^{[1
]}

机构：

[1] Keio Univ, Sch Med, Shinjuku Ku, Tokyo 1608582, Japan

来源：

OCULAR SURFACE | 2007年 / 5卷 / 02期

关键词：

clinical trials; DEWS; dry eye; dry eye WorkShop;

D O I：

暂无

中图分类号：

R77 [眼科学];

学科分类号：

100212 ;

摘要：

This report summarizes some universal concepts with regard to clinical trials in general and other issues pertaining to clinical trials specifically tailored to the study of therapeutic intervention in dry eye disease. The report also makes recommendations for logistical design and implementation of such trials. It identifies peculiarities of dry eye disease that complicate clinical trial design, such as the lack of correlation of signs and symptoms, as well as the likelihood of control interventions having a lubricant (placebo) effect. Strategies for environmental trials and controlled adverse environment trials are reviewed.

引用

页码：153 / 162

页数：10

共 50 条

[31] Design and conduct of clinical trials in hormone replacement therapy
Holinka, CF
HUMAN FERTILITY AND REPRODUCTION: THE OOCYTE, THE EMBRYO, AND THE UTERUS, 2001, 943 : 89 - 108
[32] Design and conduct of confirmatory chronic pain clinical trials
Katz, Nathaniel
PAIN REPORTS, 2021, 6 (01)
[33] The design and conduct of clinical trials to limit missing data
Little, R. J.
Cohen, M. L.
Dickersin, K.
Emerson, S. S.
Farrar, J. T.
Neaton, J. D.
Shih, W.
Siegel, J. P.
Stern, H.
STATISTICS IN MEDICINE, 2012, 31 (28) : 3433 - 3443
[34] Guidelines for the design and conduct of clinical trials on dentine hypersensitivity
Holland, GR
Narhi, MN
Addy, M
Gangarosa, L
Orchardson, R
JOURNAL OF CLINICAL PERIODONTOLOGY, 1997, 24 (11) : 808 - 813
[35] DESIGN AND CONDUCT OF CLINICAL-TRIALS IN CRITICAL CARE
INMAN, KJ
MARTIN, CM
SIBBALD, WJ
JOURNAL OF CRITICAL CARE, 1992, 7 (02) : 118 - 128
[36] CONDUCT OF CLINICAL-TRIALS IN PIGS - DESIGN AND INTERPRETATION
POMMIER, P
WESSELROBERT, S
RECUEIL DE MEDECINE VETERINAIRE, 1994, 170 (01) : 51 - 55
[37] OARSI Clinical Trials Recommendations: Design and conduct of implementation trials of interventions for osteoarthritis
Allen, K. D.
Bierma-Zeinstra, S. M. A.
Foster, N. E.
Golightly, Y. M.
Hawker, G.
OSTEOARTHRITIS AND CARTILAGE, 2015, 23 (05) : 826 - 838
[38] The conduct of orthopaedic clinical trials
Fuson, RL
Sherman, M
VanVleet, J
Wendt, T
JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, 1997, 79A (07): : 1089 - 1098
[39] Predictive factors for the placebo effect in clinical trials for dry eye: a pooled analysis of three clinical trials
Imanaka, Takahiro
Sato, Izumi
Tanaka, Shiro
Kawakami, Koji
BRITISH JOURNAL OF OPHTHALMOLOGY, 2017, 101 (11) : 1471 - 1474
[40] Design of Clinical Trials in Acute Kidney Injury: A Report from an NIDDK Workshop-Prevention Trials
Okusa, Mark D.
Molitoris, Bruce A.
Palevsky, Paul M.
Chinchilli, Vernon M.
Liu, Kathleen D.
Cheung, Alfred K.
Weisbord, Steven D.
Faubel, Sarah
Kellum, John A.
Wald, Ron
Chertow, Glenn M.
Levin, Adeera
Waikar, Sushrut S.
Murray, Patrick T.
Parikh, Chirag R.
Shaw, Andrew D.
Go, Alan S.
Chavvla, Lakhmir S.
Kaufman, James S.
Devarajan, Prasad
Toto, Robert M.
Hsu, Chi-yuan
Greene, Tom H.
Mehta, Ravindra L.
Stokes, John B.
Thompson, Aliza M.
Thompson, B. Taylor
Westenfelder, Christof S.
Tumlin, James A.
Warnock, David G.
Shah, Sudhir V.
Xie, Yining
Duggan, Emily G.
Kimmel, Paul L.
Star, Robert A.
CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY, 2012, 7 (05): : 851 - 855

← 1 2 3 4 5 →