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ARVO Statement on Registering Clinical Trials
Introduction
The editors of several leading journals of internal medicine have recently adopted a policy, originally proposed by the International Committee of Medical Journal Editors (ICMJE),
that controlled clinical trials must be registered in a publicly available database or these journals will not publish manuscripts based on the results of these trials. These standards were
published simultaneously in four leading journals of internal medicine,1-4 but they have subsequently appeared in numerous other journals and in several languages. The editors of several
leading peer-reviewed ophthalmic journals have subsequently published a joint editorial endorsing this policy,5 as has the Association of American Medical Colleges,6 and editorial and
reader commentaries in numerous publications have strongly endorsed it. The Association for Research in Vision and Ophthalmology (ARVO) completely agrees with the principles of
clinical trial registration put forth by the ICMJE and endorsed by numerous other journals.
Guidelines on Clinical Trials Registration
1. Beginning July 1, 2006, ARVO will no longer consider for publication articles dealing with clinical trials that were not registered before the first subject was enrolled.
Trials that began before this date and were not registered must be registered by July 1, 2006. The letter accompanying manuscript submission must state the beginning
date of the trial, and the date of registration.
2. The registration requirement will apply to abstracts submitted for presentation at the ARVO Meeting beginning in 2007. Investigators will be prompted to include the
registration number on the online abstract form.
3. Registration must be done on a publicly available database. At present, the only databases that are satisfactory are the NIH’s registry, http://www.clinicaltrials.gov,
and the International Standard Randomized Controlled Trials Number (http://isrctn.com). Further information about these sites can be obtained through
http://prsinfo.clinicaltrials.gov and http://www.controlled-trials.com. The ICMJE standards can be obtained at http://www.icmje.org/faq.pdf. Registration must include
completion of all 20 items on the list recommended by the WHO advisory group (Ref. 7 and see below). The list of approved registration sites will be updated on the
Frequently Asked Questions page.
4. For the purposes of this policy, a “clinical trial” consists of any study involving a new therapy of any kind, whether medical, surgical, psychological or sociological,
in which subjects are concurrently divided into two or more groups. Several treatments may be compared simultaneously, or one or more treatment groups may be
compared to a simultaneous, untreated control group. Although the division into such groups in most such trials is presently by random assignment, randomization
is not a part of the requirement for registration but only the evaluation, in the trial, of concurrent control groups. For more information on what types of clinical trials
should be registered, visit the clinical trials FAQ.
5. The size of a clinical trial is not a relevant consideration as to whether it must be registered. This policy applies not only to large, multi-institutional clinical trials sponsored
by pharmaceutical companies or other organizations, but also to individual investigators at a single institution who are conducting their own trials. The only consideration is
whether the trial is comparing an experimental therapy or therapies with a simultaneous control group, or groups.
References
1. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors.
JAMA 2004;292:1363-4.
2. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors.
Ann Int Med. 2004;141:477-8.
3. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors.
N Engl J Med. 2004;351:1250-1.
4. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors.
Lancet 2004;364:911-2.
5. Levin LA, Gottlieb JL, Beck RW, et al. Registration of clinical trials. Arch Ophthalmol 2005;123:1263-4.
Clinical Trials Index
6. Ehringhaus S, Kom D. (For the Association of American Medical Colleges) Principles for protecting integrity in the conduct and reporting of clinical trials.
Available on line at http://www.aamc.org/research/clinicaltrialsreporting/start.htm
7. DeAngelis CD, Drazen JM, Frizelle FA, et al. Is this clinical trial fully registered? – A statement from the International Committee of Medical Journal Editors.
JAMA, 2005;293:2927-9.
8. Frank RN. Potential new medical therapies for diabetic retinopathy: protein kinase C inhibitors. Am J Ophthalmol 2002;133:693-8.
9. A curious stopping rule from Hoechst Marion-Roussel [editorial]. Lancet 1997;350:155.
10. European Pimagedine Investigators. [Letter to the Editor] Early closure of European Pimagedine Trial. Lancet 1997;350:214.
Approved: ARVO Board of Trustees October 29, 2005
Revised and Approved: ARVO Board of Trustees, June 22, 2006
Contact us at clinicaltrials@arvo.org with additional questions.
ARVO® 12300 Twinbrook Parkway, Suite 250, Rockville, MD 20852, 240-221-2900
CT
72 – 1822 ARVO Clinical Trials Index
ARVO Clinical Trials Index
This is a numerical listing by Program Number of the Clinical Trial Registration information for each applicable presentation as indicated at the time of abstract
submission. This listing includes the URL for the registry site and the corresponding registration number, for example: www.clinicaltrials.gov; # NCT00335335.
Abstracts that did not indicate clinical trial registration at the time of submission are not included on this Index. See ARVO Statement on Registering Clinical Trials on
the previous page.
72 www.clinicaltrials.gov 749 www.clinicaltrials.gov 1207 www.clinicaltrials.gov
APEC-0031 Registration Number NCT00279695
85 www.clinicaltrials.gov Pending 1248 www.clinicaltrials.gov
NCT00346814 757 Audit Royal Liverpool NCT00328835
107 www.clinicaltrials.gov University Hospital 1273 Brazil
NCT00105027 766 FDA 1278 ML 3129 Ethical Committee
275 Hospital Nuestra Señora de 773 European Health Authorities KULeuven Belgium
la Luz I.A.P. Mexico 780 www.clinicaltrials.gov 1290 GMMA supported study
277 www.clinicaltrials.gov 210297 1398 tokyo women’s medical
2005-07-21 803 www.mssm.edu university no480
290 www.clinicaltrials.gov 818 Lausanne, STS-03-DS 1401 www.clinicaltrials.gov
APEC-0016 823 www.clinicaltrials.gov NCT00342927
299 MCGill NCT00326066 1402 www.clinicaltrials.gov
308 European clinical database 824 www.clinicaltrials.gov NCT00333671
(EUDRACT) NCT00323284 1413 n/a - Phase I pharmaceutical
310 www.clinicaltrials.gov 826 www.clinicaltrials.gov trial
NCT00406107 NCT00320762 1421 www.clinicaltrials.gov
311 www.clinicaltrials.gov 840 Study was not ongoing after NCT00000620
NCT00088283 1990 1429 Fundacion Hospital Nuestra
313 www.clinicaltrials.gov 845 Medical Research Council Senora de la Luz IAP
Registered 11/29/06; 847 www.clinicaltrials.gov 1430 www.clinicaltrials.gov
number pending NCT00000149 NCT 00320814
351 www.clinicaltrials.gov 851 www.clinicaltrials.gov 1431 www.clinicaltrials.gov
NCT00221364 NCT00221897 NCT00387582
372 www.ISRCTN.org 857 www.clinicaltrials.gov 1455 www.clinicaltrials.gov
CCT-NAPN-15875 NCT00000125 NCT00395551
377 www.ISRCTN.org 880 MHRA CTA 1457 www.clinicaltrials.gov
pending no.MF/8000/11727 ISRCTN85551991
380 www.clinicaltrials.gov 898 www.clinicaltrials.gov 1505 www.clinicaltrials.gov
NCT00403975, NCT00343746 NCT00357266
NCT00403715, 944 www.clinicaltrials.gov 1544 www.clinicaltrials.gov
NCT00404131 NCT00059748 NCT00088283
381 Comité de Etica de la FHNSL 955 COREC 1545 www.clinicaltrials.gov
392 Own University 999 UK national research register pending
418 www.clinicaltrials.gov ID=N0141120818 1548 Helsinki’s tenet
NCT00395759 1004 www.clinicaltrials.gov 1562 Icelandic Data Protection
421 www.clinicaltrials.gov NCT00318045 Commission
Clinical Trials Index
888888 1005 www.clinicaltrials.gov 1576 www.clinicaltrials.gov
504 Kyoto University NCT00317525 07-A-6803
515 www.clinicaltrials.gov 1012 www.clinicaltrials.gov 1632 observational case series
NCT00343746 NCT00038753 1643 www.clinicaltrials.gov
517 www.clinicaltrials.gov 1052 www.ste.ki.se NCT00000125
NCT00343746 1060 www.clinicaltrials.gov 1787 IUPUI 0108-34
520 www.clinicaltrials.gov pending 1801 www.clinicaltrials.gov
NCT00343746 1063 www.ISRCTN.org NCT00395707
651 www.clinicaltrials.gov ISRCTN40732847 1805 Nagoya Univ School of
NCT00279500 1066 www.clinicaltrials.gov Medicine clinical trial
659 RP TUE NCT00349583. 1807 University Tuebingen
670 Ethikkommission Graz 1079 local ethic commitee 1808 www.clinicaltrials.gov
675 www.clinicaltrials.gov 1104 MHRA CTA no. NCT00056836
NCT00279500345345 MF/8000/11727 1810 www.clinicaltrials.gov
685 www.clinicaltrials.gov MF/8000/11730 NCT00095433
Registration submitted 1107 www.clinicaltrials.gov 1811 www.clinicaltrials.gov
and Pending. ISRCTN54685764 NCT00320775
730 gmma supported study 1152 www.clinicaltrials.gov 1820 European Clinical Trial
745 www.clinicaltrials.gov NCT00000161 Database No
NCT00350363 1174 www.clinicaltrials.gov 2005-003132-21
NCT00056836 1822 www.clinicaltrials.gov
NCT00061594
CT
ARVO Clinical Trials Index 1825 – 4576
1825 European Clinical Trial 2761 www.clinicaltrials.gov 3913 www.clinicaltrials.gov
Database: 2005-003132-21 NCT00343746 NCT00404482
1830 www.clinicaltrials.gov 2784 www.trialregister.nl/trialreg/ 3915 www.clinicaltrials.gov
NCT00056836 index.asp NCT00403832
1831 EUDRACT 812 3920 www.umin.ac.jp/ctr/
1834 www.clinicaltrials.gov 2785 www.trialregister.nl/trial index/htm
#NCT00344227 reg/index.asp 63459
1916 Ministry of Health of the 812 3929 www.clinicaltrials.gov
Czech Republic 2868 www.clinicaltrials.gov NCT00347503
1989 www.clinicaltrials.gov NCT00320775 3957 06/Q0504/55
FDA IDE 2869 www.clinicaltrials.gov 3961 UNIFESP ETHICS
G960041/G970121 nct0056823 COMMITTEE
1992 www.clinicaltrials.gov 2870 www.clinicaltrials.gov 3974 European Community Trials
NCT00365040 NCT00242580 Database
1998 FDA G010271/S20 2871 www.clinicaltrials.gov 3975 www.clinicaltrials.gov
2111 TBD NCT00288561 NCT00145535
2115 cantonal ethical committee 2872 www.clinicaltrials.gov 3985 www.clinicaltrials.gov
Bern NCT00061594 NCT00347178
2145 www.clinicaltrials.gov 2874 www.clinicaltrials.gov 4027 Ethical Comittee University
NCT00000611 NCT00089830 of Kiel
2151 Ethics Committee Kanton 2894 www.clinicaltrials.gov 4029 www.clinicaltrials.gov
Bern APEC-015 Pending
2152 www.clinicaltrials.gov 3087 www.clinicaltrials.gov 4030 Registration pending
NCT00000145 NCT00105027 In process
2155 www.clinicaltrials.gov 3093 www.clinicaltrials.gov 4049 Indiana University IRB
NCT00393692 NCT00027222 #0208-28
2162 www.clinicaltrials.gov 3129 Technical University Munich 4118 www.clinicaltrials.gov
NCT00000145 3133 www.clinicaltrials.gov 82021
2165 www.clinicaltrials.gov NCT00347243 BRAZIL
NCT00359008 3135 www.clinicaltrials.gov 4142 www.clinicaltrials.gov
2166 www.clinicaltrials.gov NCT00347243/ APEC-0024
NCT00000145 CEP 012/06 4206 www.clinicaltrials.gov
2174 www.clinicaltrials.gov 3312 www.clinicaltrials.gov 209473
1 NCT00343746 4275 www.ISRCTN.org
2215 Hospital Essen 01/2e05- 3317 www.clinicaltrials.gov ISRCTN71482124
07/2005 NCT00343746 4286 BANPESQ - UFPR -
2233 www.clinicaltrials.gov 3336 www.clinicaltrials.gov 4421 www.clinicaltrials.gov
APEC 005 NCT00343746 NCT00263471
2234 Hospital XV-XX register 3337 www.clinicaltrials.gov 4443 www.clinicaltrials.gov
2235 Hospital XV-XX register NCT00343746. NCT00279500
2259 www.trialregister.nl/trialreg/index.asp 3349 www.clinicaltrials.gov 4447 OHTS
NTC00312390 APEC-0012 4536 www.ISRCTN.org
2267 retrospective analysis of data 3355 Fundacion Hospital Nuestra ISRCTN83325075
2280 www.umin.ac.jp/ctr/index/htm Señora de la Luz 4540 www.clinicaltrials.gov
000000518 3393 www.clinicaltrials.gov NCT00090623
2284 www.clinicaltrials.gov pending 4545 www.clinicaltrials.gov
Clinical Trials Index
in progress 3527 www.clinicaltrials.gov nct00061594
2291 www.clinicaltrials.gov NCT00346138 4549 www.clinicaltrials.gov
NCT00313118 3598 www.actr.org.au NCT00320788
2359 www.clinicaltrials.gov kyoko 4552 www.clinicaltrials.gov
NCT00404105 3652 www.clinicaltrials.gov NCT00347399
2360 www.clinicaltrials.gov NCT00000145 4557 Novartis SASL-NL 06
NCT00350246 3656 www.clinicaltrials.gov 4561 www.clinicaltrials.gov
2385 www.clinicaltrials.gov NCT00000167 NCT00061594
NCT00000113 3658 www.clinicaltrials.gov 4564 TBD
2466 www.clinicaltrials.gov NCT00345917, 4566 www.clinicaltrials.gov
NCT00395122 NCT00346060 NCT00288561
2467 www.clinicaltrials.gov 3677 www.clinicaltrials.gov 4568 www.clinicaltrials.gov
NCT00395122 NCT00346853 NCT0035445
2541 www.actr.org.au 3877 Fundaciòn Hospital Nuestra 4573 www.clinicaltrials.gov
202463 Señora de la Luz NCT00056836
2555 Ethikkommission Graz 3903 www.clinicaltrials.gov 4575 www.clinicaltrials.gov
2597 IRB-AAAA7543 NCT00406341 NCT00327470
2705 BAMPESQ - UFPR 3904 www.clinicaltrials.gov 4576 www.clinicaltrials.gov
2753 www.clinicaltrials.gov NCT00406887 NCT00056836,
NCT00350246 3905 www.clinicaltrials.gov NCT000061594
NCT00407056
CT
4577 – 6042 ARVO Clinical Trials Index
4577 www.clinicaltrials.gov 5400 www.clinicaltrials.gov
NCT00094120 NCT00407238
4578 www.clinicaltrials.gov 5418 Mount Sinai Institutional
NCT00344227 Review Board
4579 www.clinicaltrials.gov 5438 www.clinicaltrials.gov
NCT00344227 2005 2647 35
4583 www.clinicaltrials.gov 5446 www.clinicaltrials.gov
NCT00061594 1
4619 www.umin.ac.jp/ctr 5464 www.clinicaltrials.gov
/index/htm NCT00348244
Control # 07-A-675-ARVO 5482 www.clinicaltrials.gov
4681 Hospital Nuestra Señora de la NTC00343746
Luz, IAP 5523 www.clinicaltrials.gov
4751 www.clinicaltrials.gov NCT00359008
NCT00350363 5555 www.clinicaltrials.gov
4777 www.clinicaltrials.gov NCT00000125
NCT00344799 5560 www.clinicaltrials.gov
4783 www.clinicaltrials.gov NCT00348400
NCT00344799 5561 www.clinicaltrials.gov
4817 www.clinicaltrials.gov NCT00332540 and
NCT00404729 NCT00332072
4822 EudraCT (European 5562 www.clinicaltrials.gov
Community Trials Database) NCT00273481
4823 www.clinicaltrials.gov 5563 www.clinicaltrials.gov
203675 NCT00273455
4824 www.clinicaltrials.gov 5564 www.clinicaltrials.gov
NCT00348062 NCT00273442
4829 www.clinicaltrials.gov 5565 www.clinicaltrials.gov
NCT00000113 NCT00330577
4886 www.trialregister.nl/trialreg 5566 www.clinicaltrials.gov
/index.asp NCT00108017
ISRCTN2835481 5569 www.clinicaltrials.gov
4971 67980 NCT00331240
4996 AIBILI-CE39 5572 www.actr.org.au
5028 University Tuebingen ACTRN012606000265572
5030 www.clinicaltrials.gov 5573 Phase I pharmaceutical trial
209574 5574 www.clinicaltrials.gov
5035 CEP099/2005 NCT00329095
5041 www.clinicaltrials.gov 5577 www.clinicaltrials.gov
NCT00347698 Registration pending
5045 www.clinicaltrials.gov 5583 Brazil
NCT00306904 5595 www.umin.ac.jp/ctr
5083 www.clinicaltrials.gov /index/htm
NCT00401713 ikoike-oph
5095 www.clinicaltrials.gov 5623 local ethics committe
NCT00403884 5666 www.clinicaltrials.gov
Clinical Trials Index
5100 www.clinicaltrials.gov NCT00254605
NCT00403884 5672 www.clinicaltrials.gov
5104 Hungarian authorities G050140
5107 hôpital XV-XX register 5752 www.clinicaltrials.gov
5121 www.clinicaltrials.gov NCT00403702
NCT00090623 5840 www.clinicaltrials.gov
5169 www.clinicaltrials.gov HCM-001
NCT00377546 6020 www.clinicaltrials.gov
5267 www.actr.org.au NCT00388791
lavie2k 6027 www.clinicaltrials.gov
5295 CEP:091/2002-UFTM-MG- NCT00401713
Brazil 6042 www.clinicaltrials.gov
5296 CEP091/2003 NCT00280501…
5329 www.clinicaltrials.gov
NCT00350246
5341 www.clinicaltrials.gov
NCT00365677
5347 technical university munich
5350 www.clinicaltrials.gov
NCT00405028
5358 Observational case serie
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