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Biomedicinski znanstveni časopisi – stanje i perspektive

Biomedicinski znanstveni časopisi – stanje i perspektive. Ana Marušić Editor, Croatian Medical Journal President, Council of Science Editors. The future of medical journals. The future of medical journals. CMJ editorial: Double life of medical journals: Dr Paper and Mr Web

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Biomedicinski znanstveni časopisi – stanje i perspektive

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

  2. The future of medical journals

  3. The future of medical journals • CMJ editorial: Double life of medical journals: Dr Paper and Mr Web Croat Med J. 2006:47:4-6

  4. The future of medical journals • 25 biomedical journals in Croatia: • 11 provide access to full text on a web-site • 5 have an electronic journal edition (separate ISSN)

  5. Registration of Clinical Trials: ICMJE guidelinesand implications for clinical researchers • What is ICMJE and who are ICMJE editors and journals?

  6. Source:Huth EJ, Case K. The URM: Twenty-five Years Old. Science Editor 2004;27:17-21. History of ICMJE 1993 Medical Journals and the PopularMedia; Conflicts of Interest (editorial comment,2001) 1994 Advertising; Supplements 1997 URM Fifth Edition; revised in 1999,2000, and 2001 2000 Project-Specific Industry Support forResearch 2001 Policies for Reporting BiomedicalJournal Information on the Internet 2003Extensive URM revision(http://www.icmje.org/index.html) 2004 Clinical trial registration policy 1979 URM First Edition 1982 URM Second Edition 1987 Retraction of ResearchFindings 1988 Editorial Freedom andIntegrity 1988 URM Third Edition 1989 Confidentiality; The Role of the CorrespondenceColumn 1991 Competing Manuscripts Based on theSame 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-ReviewedJournal

  7. 2005

  8. 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

  9. 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

  10. 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

  11. ICMJE Policy on Clinical Trial Registration • Which trial should be registered if it is planned to publish the results in a medical journal? • Which registration database should I choose? • Which data do I have to register? • Which journals subscribe to the ICMJE trial registration policy?

  12. ICMJE Policy on Clinical Trial Registration • 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!

  13. ICMJE Policy on Clinical Trial Registration • 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

  14. ICMJE Policy on Clinical Trial Registration 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

  15. www.clinicaltrials.com

  16. www.clinicaltrials.com Total: 51047 registrations

  17. Registration around ICMJE deadline (Source: Zarin et al. N Engl J Med. 2005;353:2779)

  18. ICMJE Policy on Clinical Trial Registration Which data do I have to register? Minimal data set for trial registration defined by the World Health Organization and adopted by the ICMJE

  19. Which data do I have to register? 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 IDsMay be assigned by sponsors orother interested parties. Funding source(s)Name of the organization(s) thatprovided funding for the study.

  20. Which data do I have to register? Primary sponsorThe main entity responsible forperforming the research. Secondary sponsor(s)Secondary entitiesresponsible for performing the research. Responsible contact Public contact person for the trial personfor patients interested inparticipating. Research contact person Person to contact for scientificinquiries about the trial. Title of the studyBrief title chosen by the researchgroup (can be omitted).

  21. Which data do I have to register? Official scientific titleThis title must include the of the studyname of the intervention, thecondition 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).

  22. Which data do I have to register? 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 andKey patient characteristics that determine exclusion criteria eligibility for participation in the study. Study typeDatabase should provide drop-down lists forselection, icluding choices for randomizedvs. non-randomized, type of masking, type ofcontrols, and group assignment.

  23. Which data do I have to register? Anticipated trialEstimated enrollment date of start datethe 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 outcomePrimary outcome that the study wasdesignedto evaluate(e.g. blood pressure at 12 months) Key secondary The secondary outcomes specified in theoutcomesprotocol. Description should include time ofmeasurement (e.g. creatinine clearance at 6months).

  24. 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)

  25. ICMJE Policy on Clinical Trial Registration Which journals subscribe to the ICMJE trial registration policy? Journal members of the ICMJE: British Medical Journal Canadian Medical Association Journal Croatian Medical Journal Danish Medical Journal Dutch Medical Journal JAMA Lancet Medical Journal of Australia New England Journal of Medicine New Zealand Medical Journal The Journal of the Norwegian MedicalAssociation

  26. ICMJE Policy on Clinical Trial Registration Which journals subscribe to the ICMJE trial registration policy? 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):479-80 Arteriosclerosis, 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):193 Contemporary Clinical Trials. 2005; 26(5):517. Hypertension. 2005; 45(4):631-2.

  27. ICMJE Policy on Clinical Trial Registration Which journals subscribe to the ICMJE trial registration policy? 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):e365 Report 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.

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

  29. ICMJE policy – new developments ICMJE annual meeting in Sydney

  30. ICMJE policy – new developments New ICMJE statement,released on June 4, 2007 Clinical Trial Registration:Looking Back and Moving Ahead

  31. ICMJE policy – new developments 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.

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

  33. ICMJE policy – new developments New ICMJE statement,released on June 4, 2007 New definition of a clinical trial: any research study that prospectively assigns humanparticipants or groups of humans to one or more health-relatedinterventions to evaluate the effects on healthoutcomes.

  34. ICMJE policy – new developments New ICMJE statement,released on June 4, 2007 The ICMJE will not consider results posted in the sameclinical trials registry in which the primary registrationresides to be previous publication if the results arepresented in the form of a brief, structured (<500 words)abstract or table.

  35. ICPRT - http://www.who.int/ictrp/en/ Thank you. www.cmj.hr ana.marusic@agram.mef.hr

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