CMJ editorial: Double life of medical journals: Dr Paper and Mr Web Croat Med J. 2006:47:4-6
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)
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.
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?
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 trials registration : trials investigating disease biology trials providing preliminary data T he best answer to doubts about a trial is to – register it!
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
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
Registration around ICMJE deadline (Source: Zarin et al. N Engl J Med. 2005;353:2779)
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
Which data do I have to register? Unique trial number The unique trial number will be established by the primary registering 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 or other interested parties. Funding source(s) Name of the organization(s) that provided funding for the study.
Which data do I have to register? Primary sponsor The main entity responsible for performing 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 scientific inquiries about the trial. Title of the study Brief title chosen by the research group (can be omitted).
Which data do I have to register? Official scientific titleThis title must include the of the studyname of the intervention, the condition being studied, and the outcome (e.g. The International Study of Digoxin and Death from Congestive Heart Failure). Research ethics review Has the study at the time of registration received appropriate ethics committee approval yes/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).
Which data do I have to register? Intervention(s) A description of the study and comparison/ control intervention(s) (For a drug or other product registered for public sale anywhere in the world, this is the generic name; for an unregistered drug the generic name or company serial number is acceptable). The duration of intervention(s) must be specified. Key inclusion and Key patient characteristics that determine exclusion criteriaeligibility for participation in the study. Study type Database should provide drop-down lists for selection, icluding choices for randomized vs. non-randomized, type of masking, type of controls, and group assignment.
Which data do I have to register? Anticipated trialEstimated enrollment date of start date the first participant. Target sample size Total number of subjects the investigators plan to enroll before closing the trial to new participants. Recruitment status Is this information available (yes/no) Primary outcome Primary outcome that the study was designed to evaluate (e.g. blood pressure at 12 months) Key secondary The secondary outcomes specified in the outcomesprotocol. 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)
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 Medical Association
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.
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.
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
ICMJE policy – new developments ICMJE annual meeting in Sydney
ICMJE policy – new developments Clinical Trial Registration: Looking Back and Moving Ahead New ICMJE statement, released on June 4, 2007
ICMJE policy – new developments 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. New ICMJE statement, released on June 4, 2007
ICMJE policy – new developments 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. New ICMJE statement, released on June 4, 2007
ICMJE policy – new developments 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. New ICMJE statement, released on June 4, 2007