Artículos sobre ensayos clínicos y ética

Registros de ensayos clínicos y otras bases de datos

• Observatorio de ensayos clínicos
• Registro de ensayos clínicos
• Registro de resultados de ensayos clínicos

Observatorio de ensayos clínicos

PAHO. Implementing National Health Observatories. Operation Approach and Strategic Recommendations. Washington DC: PAHO, Technical Series on Inforamtion for Decision-Making. PWR CHI/AH/02

Registro de ensayos clínicos

American Medical Informatics Association (AMIA). Global Trial Bank. http://www.amia.org/gtb/

Carvalheiro J da Rocha, Quental C. Registro de ensaios clínicos: a discussăo internacional e os posicionamentos possíveis para o Brasil. RECIIS 2007; 1 (1): 63-69. http://www.reciis.cict.fiocruz.br/index.php/reciis/article/viewPDFInterstitial/53/71#page=65

Collier R. Clinical trial registries becoming a reality, but long-term effects remain uncertain. CMAJ 2009; 180(10):1007-8 http://ecmaj.com/cgi/content/full/cmaj;180/10/1007

Damle A, Lurie P, Wolfe SM. A policy study of clinical trial registries and results databases. Public Citizen’s Health Research Group. 2007 http://www.citizen.org/documents/1819.pdf

DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. International Committee of Medical Journal Editors. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. JAMA. 2005;293:2927-9. http://www.icmje.org/clin_trialup.htm  http://content.nejm.org/cgi/content/full/NEJMe048225

DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351:1250-1

Dickersin K, Rennie D. Registering Clinical Trials. JAMA 2003;290(4):516-23

Downing G. Designation of clinical research information integration as an objective of “meaningful use” of electronic health record systems. Presentation to the HIT Policy Committee, Office of the Secretary. Department of Health and Human Services, 28 de octubre de 2009.

Elliott TR. Registering randomized clinical trials and the case for CONSORT. Exp Clin Psychopharmacol 2007; 15(6): 511-518 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2518067

European Commission. Guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medical products provided in article 57 of regulation (EC) No 726/2004  http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2008:168:0003:0004:EN:PDF

Federación Internacional de la Industria del Medicamento (IFPMA). Postura conjunta sobre la revelación de información de ensayos clínicos mediante registros y bases de datos. Disponible en http://www.ifpma.org/clinicaltrials.html Acceso 1 de Noviembre de 2009

Fegan GW, Lang TA. Could an open-source clinical trial data-management system be what we have all been looking for? PLoS Medicine 2008;5(3): e6  http://medicine.plosjournals.org/archive/1549-1676/5/3/pdf/10.1371_journal.pmed.0050006-L.pdf

Giraudeau B, Ravaud P. Preventing bias in cluster randomized trials. PLoS Medicine 2009; 6(5)e1000065 http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000065

Horton R. Trial registers: protecting patients, advancing trusts. The Lancet 2006; 367:1633 http://linkinghub.elsevier.com/retrieve/pii/S0140673606687096  http://download.thelancet.com/pdfs/journals/0140-6736/PIIS0140673606687096.pdf

Horton R, Smith R. Time to register randomised trials. The case is now unanswerable. BMJ. 1999;319:865-6.

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. Disponible en: http://clinicaltrials.ifpma.org/fileadmin/files/pdfs/EN/November_10_2009_Updated_Joint_Position_on_the_Disclosure_of_Clinical_Trial_Information_via_Clinical_Trial_Registries_and_Databases.pdf

Karlberg JPE, Yau HKC. Clinical trial registration in Higgledy-Piggledy. Clinical Trial Magnifier 2008; 1(12):296-7

Krleža-Jeric K. Clinical trial registration: the differing views of industry, the WHO, and the Ottawa Group. PLoS Medicine 2005; 2 (11) e 378  http://medicine.plosjournals.org/perlserv?request=get-document&doi=10.1371/journal.pmed.0020378

Krleža-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C. Principios del registro internacional de protocolos y resultados de ensayos clínicos a base de intervenciones de salud en seres humanos: Declaración de Ottawa (parte 1). Revista Panamericana Salud Pública 2006; 19 (6):413-416. http://journal.paho.org/uploads/1153839396.pdf

Laine C, Horton R. Clinical trial registration. BMJ 2007; 334:1177-8

Lemmens T, Bouchard RA. Registro obrigatório de teste clínico: reconstruindo a confianza pública na pesquisa médica. Revista Bioética 2007; 15 (1): 49-64

Levin LA, Palmer JG. Institutional review boards should require clinical trial registration. Arch Intern Med 2007; 167:1576-80

McCray A, Ide NC. Design and implementation of a national clinical trial registry. Journal of the American Medical Informatics Association 2000; 7(3): 313-323

Moja LP, Moschetti I, Nurbhai M, Compagnoni A, Liberati A et al (2009) Compliance of clinical trial registries with the World Health Organization minimum data set: a survey. Trials 10:56

Rabin RC. No se tiene en cuenta la obligación de registrar los ensayos clínicos como condición previa para que se publiquen artículos The New York Times, 8 de septiembre de 2009 Ver Boletín Fármacos 2009; 12(5)

Reveiz L, Cardona AF, Ospina EG. Clinical trial registration. N Engl J Med. 2005;352(2):198-9

Reveiz L, Chan AW, Krleza-Jeric K, Granados C, Pinart M, Etxeandia I, Rada D, Martinez M, Cardona AF. Trial registration can be useful source of information for quality assessment: A study of randomized trial records retrieved from the WHO search portal. Peer Review Congress; Vancouver, September 2009.

Reveiz L, Krleža-Jerić K, Chan AW, De Aguiar S. Do trialist endorse clinical trial registration? Survey of a Pubmed sample. Trials. 2007; 8(30) doi:10.1186/1745-6215-8-30 http://www.trialsjournal.com/content/8/1/30

Reveiz L, Delgado MB, Urrutia G, Ortiz Z, Garcia Dieguez M, Marti-Carvajal A et al. The Latin American Ongoing Clinical Trial Register (LATINREC). Rev Panam Salud Publica. 2006;19(6):417-22 http://www.who.int/ictrp/LATINREC_2006.pdf

Roberts I. An amnesty for unpublished trials. BMJ. 1998;317:763-764

Rockhold FW, Krall RL Trial summaries on results databases and journal publication. The Lancet 2006; 367:1635-1636 http://download.thelancet.com/pdfs/journals/0140-6736/PIIS0140673606687102.pdf

Rockhold FW, Krall RL. Clinical trial registration. PLoS Medicine 2006; 3 (3): e161 http://medicine.plosjournals.org/archive/1549-1676/3/3/pdf/10.1371_journal.pmed.0030157-S.pdf

Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM, 2009 Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis. PLoS Med 6(9): e1000144 doi:10.1371/journal.pmed.1000144

Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, Ozaki D, et al. Evaluation and recommendations on good clinical laboratory practice guidelines for Phase I-III Clinical Trials. PLoS Medicine 2009; 6(5)e1000067 http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000067

Scherer M, Trelle S. Opinions on registering trial details: a survey of academic researchers. BMC Health Services Research 2008; 8:18 doi:10.1186/1472-6963-8-18 http://www.biomedcentral.com/1472-6963/8/18

Sekeres M, Gold JL, Chan A, Lexchin J, Moher D, et al (2008) Poor Reporting of Scientific Leadership Information in Clinical Trial Registers. PLoS ONE 3(2): e1610 doi:10.1371/journal.pone.0001610

Sim I, Chan AW, Gülmezoglu, Evans T, Pang T. Clinical trial registration: transparency is the watchword. The Lancet 2006; 367:1631-1633. http://download.thelancet.com/pdfs/journals/0140-6736/PIIS0140673606687084.pdf

Sim I, Detner DE. Beyond trial registration: a global trial bank for clinical trial reporting. PLoS Medicine 2005; 2(11)e365 http://medicine.plosjournals.org/perlserv?request=get-document&doi=10.1371/journal.pmed.0020365

Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol. 1986;4(10):1529-41.

Verstraete M. Registry of prospective clinical trials: first report. Thromb Diath Hemorrh. 1975;33:655-663

WHO. Trial Registration Data Set. http://www.who.int/ictrp/data_set/en/print.html

Williams HC. Cars, CONSORT 2010, and Clinical Practice. Trials 2010; 11:33 http://www.trialsjournal.com/content/11/1/33

Wood AJJ. Progress and deficiencies in the registration of clinical trials. NEJM 2009; 360(8): 824-830.

Zarin DA, Tse T, Ide NC. Trial Registration at ClinicalTrials.gov between May and October 2005. NEJM 2005;353(26):2779-87

Registro de resultados de ensayos clínicos

Damle A, Lurie P, Wolfe SM. A policy study of clinical trial registries and results databases. Public Citizen’s Health Research Group. 2007 http://www.citizen.org/documents/1819.pdf

Ghersi D, Clarke M, Berlin J et al. Reporting of clinical trials: a discussion paper. WHO Bulletin 2008; 86(6)

http://www.who.int/bulletin/volumes/86/6/08-053769/en/print.html

Kaiser J. Making clinical data widely available. Science 2008; 322:217

Krleza-Jeric K, Djubegovic B, Nasser M, Reveiz L, Huic M, Lemmens T, Sim I, Armstrong W, Metz C, Elemam K, Wager E. International standards for Public Reporting of Clinical Trial Outcomes and Results (PROCTOR): a proposal to increase the quality of evidence produced by systematic reviews. Cochrane Colloquium Singapur, October 2009.

Miller JD. Registering clinical trial results. The next step. JAMA 2020; 303:773-4

PLoS Medicine Editors. Next Stop, don’t block the doors: opening up access to clinical trial results. PLoS Medicine 2008; 5(7): e160 http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050160

Rockhold FW, Krall RL Trial summaries on results databases and journal publication. The Lancet 2006; 367:1635-1636 http://download.thelancet.com/pdfs/journals/0140-6736/PIIS0140673606687102.pdf

Sim I, Detner DE. Beyond trial registration: a global trial bank for clinical trial reporting. PLoS Medicine 2005; 2(11)e365 http://medicine.plosjournals.org/perlserv?request=get-document&doi=10.1371/journal.pmed.0020365

Tse T, Williams RJ, Zarin DA. Reporting “basic results” in ClinicalTrials.gov. Chest. 2009;136(1):295-303