Biomedicinski znanstveni časopisi – stanje i perspektive Ana Marušić Editor, Croatian Medical Journal President, Council of Science Editors

Biomedicinski znanstveni časopisi – stanje i perspektive

Ana Marušić

Editor, Croatian Medical Journal

President, Council of Science Editors

The future of medical journals


CMJ editorial:

Double life of medical journals: Dr Paper and Mr Web

Croat Med J. 2006:47:4-6


25 biomedical journals in Croatia:11 provide access to full text

on a web-site5 have an electronic journal

edition (separate ISSN)

Registration of Clinical Trials: ICMJE guidelines and implications for clinical researchers

What is ICMJE and who are ICMJE editors and journals?

History of ICMJE

1979 URM First Edition

1982 URM Second Edition

1987 Retraction of Research Findings

1988 Editorial Freedom and Integrity

1988 URM Third Edition

1989 Confidentiality; The Role of the Correspondence Column

1991 Competing Manuscripts Based on the Same Study; Order of Authorship; Guidelines for the Protection of Patients’ Rights to Anonymity

1991 URM Fourth Edition; revised in 1993 and 1994

1992 Definition of a Peer-Reviewed Journal

1993 Medical Journals and the Popular Media; Conflicts of Interest (editorial comment, 2001)

1994 Advertising; Supplements

1997 URM Fifth Edition; revised in 1999, 2000, and 2001

2000 Project-Specific Industry Support for Research

2001 Policies for Reporting Biomedical Journal Information on the Internet

2003 Extensive URM revision(http://www.icmje.org/index.html)

2004 Clinical trial registration policy

Source: Huth EJ, Case K. The URM: Twenty-five Years Old. Science Editor 2004;27:17-21.

2005

Statement on Clinical Trial Registration

call for comprehensive registration of trials as the first step in alleviating selective data presentation on clinical trials in medical literature

:

Cavtat, Croatia, 2004

Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors.

De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB; International Committee of Medical Journal Editors.

Croat Med J. 2004; 45: 531-532.

http://www.cmj.hr/2004/45/5/15495274.pdf

Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors.

De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB.

Croat Med J. 2005; 46: 499-501.

http://www.cmj.hr/2005/46/4/16100751.pdf

ICMJE Policy on Clinical Trial Registration

1. Which trial should be registered if it is planned to publish the results in a medical journal?

2. Which registration database should I choose?

3. Which data do I have to register?

4. Which journals subscribe to the ICMJE trial registration policy?


Which trial should be registered if it is planned to publish the results in a journal?

All clinically directive trials which test any clinical hypothesis about health intervention and its outcomes

No need for phase 1 trialsregistration : trials investigating disease

biology trials providing preliminary data

The best answer to doubts about a trial is to – register it!


Which registration database should I choose?

must be accessible to the public at no charge

must be open to all prospective registrants (meaning that investigators are able to register without restriction by geographic location, academic affiliation, patient demographics, or clinical condition)

must be managed by a not-for-profit organization

there must be a mechanism to ensure the validity of the registration data

should be electronically searchable

must include all data from the minimal data set


Which registration database?Clinical Trials database of the NLM

(http://www.clinicaltrials.gov) International Standard Randomised Controlled Trial

Number, UK (http://isrctn.org) The Australian Clinical Trials Registry

(http://www.actr.org.au)University Hospital Medical Information Network, Japan

(http://www.umin.ac.jp)Dutch Cochrane Centre

(http://www.trialregister.nl/trialreg/index.asp) International Clinical Trials Registry Platform (ICTRP) of the

WHO – international norms and standards for trial registration

www.clinicaltrials.com

www.clinicaltrials.comTotal: 51047 registrations

Registration around ICMJE deadline

(Source: Zarin et al. N Engl J Med. 2005;353:2779)


Which data do I have to register?

Minimal data set for trial registration defined by the World Health Organization and adopted by the ICMJE


Unique trial number The unique trial number will beestablished by the primaryregistering entity (the registry).

Trial registration date The date of registration will be established by the primary registering entity.

Secondary IDs May be assigned by sponsors orother interested parties.

Funding source(s) Name of the organization(s) thatprovided funding for the study.


Primary sponsor The main entity responsible forperforming the research.

Secondary sponsor(s) Secondary entities responsible for performing the research.

Responsible contact Public contact person for the trial person for patients interested in

participating.

Research contact person Person to contact for scientificinquiries about the trial.

Title of the study Brief title chosen by the researchgroup (can be omitted).


Official scientific title This title must include the of the study name of the intervention, the

condition being studied, and theoutcome (e.g. The InternationalStudy of Digoxin and Death fromCongestive Heart Failure).

Research ethics review Has the study at the time ofregistration received appropriateethics committee approvalyes/no)?

(It is assumed that all registered trials will be approved by an ethics board before commencing.)

Condition Medical condition being studied (asthma, myocardial

infarction).


Intervention(s) A description of the study and comparison/control intervention(s) (For a drug or otherproduct registered for public sale anywherein the world, this is the generic name; for anunregistered drug the generic name orcompany serial number is acceptable). Theduration of intervention(s) must be specified.

Key inclusion and Key patient characteristics that determine exclusion criteria eligibility for participation in the study.

Study type Database should provide drop-down lists forselection, icluding choices for randomizedvs. non-randomized, type of masking, type

ofcontrols, and group assignment.

Which data do I have to register?Anticipated trial Estimated enrollment date of start date the first participant.

Target sample size Total number of subjects the investigatorsplan to enroll before closing the trial tonew participants.

Recruitment status Is this information available (yes/no)

Primary outcome Primary outcome that the study was designedto evaluate (e.g. blood pressure at 12 months)

Key secondary The secondary outcomes specified in theoutcomes protocol. Description should include time of

measurement (e.g. creatinine clearance at 6 months).

Quality of registration entries?

76% Industry Trials had Entries Quality:

17% Vague 19% Domain without specific measure 23% Specific measure without time frame 10% Time frame without specific measure 31% Specific measure and time frame

(Source: D Zarin, ClinicalTrials.gov, April 2007)


Which journals subscribe to the ICMJE trial registration policy?

Journal members of the ICMJE:British Medical JournalCanadian Medical Association Journal Croatian Medical JournalDanish Medical Journal Dutch Medical JournalJAMALancetMedical Journal of AustraliaNew England Journal of MedicineNew Zealand Medical JournalThe Journal of the Norwegian Medical Association



AIDS. 2005; 19(2):105.Am J Transplant. 2005; 5(4 Pt 1):643.American Journal of Physical Medicine & Rehabilitation. 2005; 84(1):3-4.Arch Dis Child. 2006; 91(1):93.Archives of General Psychiatry. 2006; 63(1):100.Archives of Ophthalmolology. 2005; 123(9):1263-4.Archives of Dermatology. 2005; 141(1):76-7; discussion 75.Archives of Otolaryngology – Head & Neck Surgery. 2005; 131(6):479-80Arteriosclerosis, Thrombosis & Vascular Biology. 2005; 25(4):873-4.Arthritis and Rheumatism. 2005; 52(8):2243-7.British Journal of Dermatology. 2005; 152(5):859-60.Circulation Research. 2005; 96(5):600-1.Circulation. 2005; 111(10):1337-8.Clinical Trials. 2005; 2(2):193Contemporary Clinical Trials. 2005; 26(5):517.Hypertension. 2005; 45(4):631-2.



Indian Journal of Medical Ethics. 2005; 2(3):74-5.Investigacion Clinica. 2004; 45(4):295-6.Journal of the American Academy of Dermatology. 2005; 52(5):890-2.Journal of the American Osteopathic Association. 2004; 104(10):409-10.Journal of the American Sociology of Nephrology. 2005; 16(4):837.Journal of Medical Internet Research. 2004; 6(3):e35.Journal of National Cancer Institute. 2005; 97(6):410-1.Journal of Athletic Training 2005; 40(1):8.Medicina Clinica. 2005; 124(16):638-9.Nephrology, Dialysis, Transplantation. 2005; 20(4):691.Paediatric Anaesthesia. 2006; 16(1):92.PLoS Med. 2005; 2(11):e365Report on Medical Guidelines & Outcomes Research. 2004; 15(19):1-2, 6-7.Stroke. 2005; 36(4):924-5.Transplantation. 2005 Apr 15;79(7):751.



J Pediatr Surg. 2007 Apr;42(4):601-2Surg Innov. 2007 Mar;14(1):5-6Ann Surg. 2007 Apr;245(4):505-6Surg Laparosc Endosc Percutan Tech. 2007 Apr;17(2):71-2J Vasc Surg. 2007 Apr;45(4):845Ann Thorac Surg. 2007 Apr;83(4):1583-4Surg Obes Relat Dis. 2007 Mar-Apr;3(2):107-8Br J Surg. 2007 Apr;94(4):511-2J Thorac Cardiovasc Surg. 2007 Apr;133(4):859-60Dis Colon Rectum. 2007 Mar 25; [Epub ahead of print] World J Surg. 2007 Apr;31(4):617-8J Surg Res. 2007 Apr;138(2):154-5

ICMJE policy – new developments

ICMJE annual meeting in Sydney


Clinical Trial Registration:Looking Back and Moving Ahead

New ICMJE statement,released on June 4, 2007


In addition to accepting registration in any of the 5 existing registries, the ICMJE will accept registration of clinical trials in any of the primary registers that participate in the WHO ICTRP. Registration in a partner register only is insufficient.


ICPRT - http://www.who.int/ictrp/en/


New definition of a clinical trial: any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.



The ICMJE will not consider results posted in the same clinical trials registry in which the primary registration resides to be previous publication if the results are presented in the form of a brief, structured (<500 words) abstract or table.


ICPRT - http://www.who.int/ictrp/en/

Thank you.

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Biomedicinski znanstveni časopisi – stanje i perspektive Ana Marušić Editor, Croatian Medical Journal President, Council of Science Editors