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

[21] DESIGN AND CONDUCT OF CLINICAL TRIALS IN MYOCARDIAL INFARCTION
REID, DD
CIRCULATION, 1969, 40 (5S4) : IV91 - &
[22] DESIGN AND CONDUCT OF CLINICAL-TRIALS IN OSTEOARTHRITIS
ALTMAN, RD
SCANDINAVIAN JOURNAL OF RHEUMATOLOGY, 1990, : 24 - 27
[23] ISSUES IN THE DESIGN AND CONDUCT OF CLINICAL-TRIALS
HENNEKENS, CH
JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1984, 73 (06) : 1473 - 1476
[24] A primer on the design, conduct, and interpretation of clinical trials
Appel, Lawrence J.
CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY, 2006, 1 (06): : 1360 - 1367
[25] Clinical trials workshop
David, Mendelow A.
NEUROTRAUMA AND VASCULAR NEUROSURGERY: JOINT EANS ANNUAL MEETING - 4TH WORLD ICH CONFERENCE 2011, 2011, : 25 - 29
[26] Specific recommendations to improve the design and conduct of clinical trials
Mark J. Kupersmith
Nathalie Jette
Trials, 24
[27] CANTAM for conduct of clinical trials
Ntoumi, F.
Ouwe-Missi-Oukem-Boyer, O.
TROPICAL MEDICINE & INTERNATIONAL HEALTH, 2012, 17 : 71 - 71
[28] ISSUES IN DESIGN AND CONDUCT OF RANDOMIZED BEHAVIORAL CLINICAL TRIALS
Kaufman, Peter G.
Powell, Lynda H.
Freedland, Kenneth E.
ANNALS OF BEHAVIORAL MEDICINE, 2015, 49 : S2 - S2
[29] Specific recommendations to improve the design and conduct of clinical trials
Kupersmith, Mark J.
Jette, Nathalie
TRIALS, 2023, 24 (01)
[30] GUIDELINES FOR THE DESIGN AND CONDUCT OF AIDS CLINICAL-TRIALS
COTTON, DJ
POWDERLY, WG
FEINBERG, J
ABRAMS, DI
CHAISSON, RE
WHEAT, LJ
FINKELSTEIN, DM
TALLMAN, V
ZIMMER, B
BERZON, R
FOGELMAN, I
PHAIR, J
CLINICAL INFECTIOUS DISEASES, 1993, 16 (06) : 816 - 822

← 1 2 3 4 5 →