Salud y Fármacos is an international non-profit organization that promotes access and the appropriate use of pharmaceuticals among the Spanish-speaking population.
Salud y Fármacos is an international non-profit organization that promotes access and the appropriate use of pharmaceuticals among the Spanish-speaking population.
Buenas prácticas clínicas
Buenas Prácticas Clínicas: Documento de las Américas. OPS. http://www.sac.com.ar/comite_bioetica/archivos/documento_de_las_americas.pdf
Capacidad técnica para ejecutar ensayos clínicos
Schluger N, Karunakara U, Lienhardt C, Nyirenda T, Chaisson R. Building clinical trials capacity for tuberculosis drugs in high-burden countries. PLoS Medicine 2007; 4(11) e302. http://medicine.plosjournals.org/archive/1549-1676/4/11/pdf/10.1371_journal.pmed.0040302-L.pdf
Reclutando pacientes
Francis D, Roberts I, Elbourne DR, Shakur J et al. Marketing and clinical trials: a case study. Trials 2007; 8:37 http://www.trialsjournal.com/content/pdf/1745-6215-8-37.pdf
Williams B, Entwistle V, Haddow G, Wells M. Promoting research participation: why not advertise altruism? Social Science and Medicine 2008; 66: 1451-1456
Efectos indeseables/eventos adversos y ensayos clínicos
Cardon PV, Dommel FW, Trumble RR. Injuries to research subjects: A survey of investigators. NEJM 1976: 295(12):650-654
Evans D, Smith M, Pillen L. Big Pharma’s shameful secret. Bloombergs Markets December 2005. http://www.bloomberg.com/specialreport/pharma.pdf
Evaluación de la calidad de los ensayos clínicos
Aragón E, Gómez MD. La calidad de los datos de los ensayos clínicos: El papel del CRA ICB Digital 2008;52. http://www.icf.uab.es/icbdigital/pdf/resumen/resumen52.pdf
Borrman S, Peto T et al. Revisiting the design of phase II clinical trials of antimalarial drugs for uncomplicated Plasmodium Falciparum malaria. PLoS Medicine 2008; 5(11):e227 http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050227
Hirji KF. No short-cut in assessing trial quality: a case study. Trials 2009; 10 (1) http://www.trialsjournal.com/content/10/1/1
Krumholz HM, Lee TH. Redifining quality – implications of recent clinical trials. NEJM 358:24: 2537-2539
Financiamiento de los ensayos clínicos
Bassand JP, Martin J, Ryden L, Simoons M. The need for resources for clinical research: the European Society of Cardiology calls for European, international collaboration. The Lancet 2002; 360:1866-1869.
Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ 2009; 180(3): 277-8 http://www.canadianmedicaljournal.ca/cgi/content/full/180/3/277
Gelland WF et al. Implications of recent clinical trials on pay-for-performance. Am J Health-Syst Pharm 2009; 66:864-867
Karlberg JPE. Magnifier Subscriber Survey – Institutional indirect fees and administrative fees for industry sponsored clinical trials. Clinical Trials Magnifier 2009; 2(2): 95-100
Karlberg JPE. Magnifier Subscriber Survey – Indirect fee and IRB fee among US Clinical Institutions. Clinical Trials Magnifier 2009; 2(2): 102-105.
Kalberg JPE, Yau HKC Investigator initiated trials contractual affairs, Clinical Trial Magnifier 2009; 2(5):246-260
Lewis TR, Reichman JH, So AD. The case for public funding and public oversight of clinical trials. Economists’ Voice. Enero, 2007 http://www.bepress.com/ev/vol4/iss1/art3/
Interrupción de ensayos clínicos
Bassler D, Briel M, Montori VM, Lane M, Glasziou P. Zhou Q, Heels Ansdell D, Walter SD, Guyatt GH, and the STOPIT-2 Study Group. Stopping randomized trials early for benefit and estimation of treatment effects. Systematic review and meta-regression analysis. JAMA 2010; 303:1180-7. ID 88155
Boje Jensen G. Early termination of drug trials. What are the ramifications for drug companies and drug safety monitoring boards? BMJ 2007; 334:326 http://www.bmj.com/cgi/content/full/334/7589/326?ck=nck
Gordian MA, Singh N, Zemmet RW. Why drugs fall short in late-stage trials. McKinsey Quarterly, 4 de enero, 2007 Hay que registrarse pero se puede obtener en http://www.manyworlds.com/exploreCO.aspx?coid=CO140717513354
Mueller PS, Montori VM, Bassler D, Koeing BA, Guyatt GH. Ethical issues in stopping randomized trials early because of apparent benefit. Ann Intern Med 2007; 146:878-81
Monitoreo de ensayos clínicos
Aragón E, Gómez MD. La calidad de los datos de los ensayos clínicos: El papel del CRA ICB Digital 2008;52. http://www.icf.uab.es/icbdigital/pdf/resumen/resumen52.pdf
Buchanan D et al. Assuring adequate protections in international health research: a principled justification and practical recommendations for the role of community oversight. Public Health Ethics 2008; 1:246-257 http://phe.oxfordjournals.org/cgi/reprint/1/3/246
Fleming TR, Ellenberg S, DeMets DL. Monitoring clinical trials: issues and controversies regarding confidentiality. Statistics in Medicine 2002, 21:2843-2851
Kipper DJ Goncalves dos Santos A. Sistema gerencial de acompanhamento de protocolos de pesquiza envolvendo ensaios clínicos. Revista Bioética 2007; 15 (1): 141-156
Klimovsky E. Reporte de eventos adversos serios. ¿Reporte de eventos adversos serios”>Confusión Regulatoria? Revista Fecicla 2008; 2: 10-11 www.fecicla.org
London L. Ethical oversight of public health research: can rules and IRBs make a difference in developing countries? AJPH 2002; 92(7):1079-1084 http://www.ajph.org/cgi/content/abstract/92/7/1079
Peppercorn J, Buss WG, Fost N, Godley PA. The dilemma of data-safety monitoring: provision of significant new data to research participants. The Lancet 2008; 371:527-529
Tharmanathan P, Calvert M, Hampton J, Freemantle N. The use of interim data and data monitoring committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias. BMC Medical Research Methodology 2008; 8:12 http://www.biomedcentral.com/content/pdf/1471-2288-8-12.pdf
Monitoreo de los medicamentos después de la comercialización
Berlin JA, Glasser SC, Ellenberg SS. Adverse event detection in drug development: recommendations and obligations beyond phase 3. American Journal of Public Health 2008; 98 (8):1366-1371
Cardon PV, Dommel FW, Trumble RR. Injuries to research subjects: A survey of investigators. NEJM 1976: 295(12):650-654
Inspecciones/supervisión de ensayos clínicos
Department of Health and Human Services. Office of Inspector General. The Food and Drug Administration’s oversight of clinical trials. Septiembre 2007. http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf
Harris G. Report assails FDA oversight of clinical trials. New York Times, 28 de septiembre, 2007 http://www.nytimes.com/2007/09/28/health/policy/28fda.html?ref=health
Karlberg JPE. US FDA Site inspection findings, 1997-2008, fail to justify globalization concerns. Clinical Trial Magnifier 2009; 2(4)194-212
Información de resultados a participantes
Cooper M. Sharing data on results with study participatns: report on a survey of cultural anthropologists. Journal of Empirical Research on Human Research Ethics 2008; 3(4): 19-34
Fernandez CV, Kodish E, Weijer C. Informing study participants of research results: An ethical imperative. IRB 2003; 25(3):12-19
Fernandez CV, Skedgel C, Weijer C. Considerations and costs of disclosing study findings to research participants. Canadian Medical Association Journal 2004; 170 (9): 1417-1419
MacNeil SD, Fernandez CV. Informing research participants of research results: analysis of Canadian university bases research ethics board policies. Journal of Medical Ethics 2006; 32(1): 49-54
Partridge AH, Wong JS, Knudsen K, Gelman R, Sampson E, Gadd M et al. Offering participants results of a clinical trial: sharing results of a negative study. The Lancet 2005; 365:963-64. Se puede ver el resumen en http://www.ncbi.nlm.nih.gov/pubmed/15766998
Shalowitz DI, Miller FG. Communicating the results of clinical research to participants: attitudes, practices and future directions. PLoS Medicine 2008; 5(5):714-720 e91 ftp://ftp.apop.allenpress.com/EP-inbox/plme-05-05-collect/plme-05-05-07.pdf
Publicación de resultados
Altman DG et al. The revised CONSORT Statement for reporting randomized trials: explanation and elaboration. Annals of Internal Medicine 2001; 134 (8):663-694
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schultz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276(8):637-639
Bell JG, Brady M, Copeland LJ. The ethics of reporting and disseminating results of clinical research trials. Cancer 2004; 100(6):1107-1109
Boutron I et al. Extending the CONSORT Statement to randomized trials of nonpharmacological treatment: explanation and elaboration. Annals of Internal Medicine 2008; 148:295-309
Campbell M et al. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328:702-708.
Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials by the Canadian Institutes of Health Research. CMAJ. 2004;171:735-40.
Chan AW, Haahr MT, Hróbjartsson A, Gotzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457-65
Clarke M. Standardising outcomes in paediatric clinical trials. PLoS Medicine 2008; 5(4): e102 http://medicine.plosjournals.org/archive/1549-1676/5/4/pdf/10.1371_journal.pmed.0050102-L.pdf
Couzin J. And how the problems eluded peer reviewers and editors.Science 2006; 311:23-4
Dawes K. Ghost writers need to be more visible. BMJ 2007 (334):208
DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, C . Laine C, Marusic A, Overbeke A . Is this clinical trial fully registered? A statement from the international committee of medical journal editors. JAMA 2005; 293 (23)1-3. http://www.icmje.org/clin_trialup.htm http://content.nejm.org/cgi/content/full/NEJMe048225
Decullier E, et al. Inadequate dissemination of phase I trials: a retrospective cohort study. PLoS Medicine 2009; 6(2): e1000034 www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000034
Drazen JM, Van der Weyden MB, Sahni P, Rosenberg J, Marusic A, Laine C, Kotzin S, Horton R, Hérbert PC, Haug C, Godlee F, Frizelle FA, De Leeuw PW, DeAngelis CD. Uniform format for disclosure competing interests in the ICMJE, CMAJ 2009; 181:565
Dwan K, Gamble C, Williamson PR et al. Reporting of clinical trials: a review of research funders’ guidelines. Trials 2008; 9:66 doi:10.1186/1745-6215-9-66 http://www.trialsjournal.com/content/9/1/66
Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, Decullier E, Easterbrook PJ, Von Elm E, Gamble C, Ghersi D, Ioannidis JP, Simes J, Williamson PR. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008;3(8):e3081.
Egger M, Juni P, Bartlett C, Holenstein F, Sterne J. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study. Health Technol Assess. 2003;7:1-76
Gagnier JJ. Reporting randomized, controlled trials of herbal interventions: An elaborated CONSORT Statement. Annals of Internal Medicine 2006; 144:364-367
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
Gøtzsche PC, Hróbjartsson A, Johansen HK, Altman DG, Chan AW. Constraints on publication rights in industry-initiated clinical trials. JAMA 2006; 295 (14):1645-1646. http://jama.ama-assn.org/cgi/content/full/295/14/1645
Gøtzsche PC et al. Lessons from and cautions about noninferiority and equivalence randomized trials. JAMA 2006; 295 (10): 1172-1174
Grant R. Renal Researchers faked data. The Scientist, News Blog, 13 de julio de 2009
Hall R, de Antueno C, Webber A. Canadian Research Ethics Board. Publication bias in the medical literature: a review by a Canadian Research Ethics Board. Can J Anaesth. 2007;54(5):380-8.
Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, and the Consort Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts. PLoS Medicine 2008; 5(1) e20 http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050020
Hopewell S et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts. The Lancet 2008; 371: 281-283.
Hopewell S, Altman DG, Moher D, Schulz KF. Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal ‘Instructions to Authors’. Trials 2008, 9:20 http://www.trialsjournal.com/content/pdf/1745-6215-9-20.pdf
Hopewell S, McDonald S, Clarke M, Egger M. Grey literature in meta-analyses of randomized trials of health care interventions. Cochrane Database Syst Rev. 2007;(2):MR000010.
Hopewell S, Clarke M, Stewart L, Tierney J. Time to publication for results of clinical trials. Cochrane Database Syst Rev. 2007;(2):MR000011
ICMJ. Declaración Uniforme de Conflictos de Interés para las revistas que cuentan con revisión por pares. http://www.icmje.org/coi_disclosure.pdf
Ioannidis JPA et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Annals of Internal Medicine 2004; 141:781-788
Le Henanff A et al. Quality of reporting of noninferiority and equivalence randoized trials. JAMA 2006; 295 (10):1147-1151
Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: A literature analysis. PLoS Med 2008; 5(9): e191
Lee KP, Boyd EA, Holroyd-Leduc JM, Bacchetti P, Bero LA. Predictors of publication: characteristics of submitted manuscripts associated with acceptance at major biomedical journals. Med J Aust. 2006; 184 (12):621-6.
Liberati A, Altman DG, Tetzlaff J, Murlow C, Gøtzsche PC, Ioannidis JPA, Clarke M, Deverreausx PJ, Kleijnen J, Moher D. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and Elaboration. Annals of Internal Medicine 2009; 151(4) W-65-W94; and also PLoS Medicine 2009; 6(7): e1000100 http://www.plosmedicine.org/article/info:doi%2F10.1371%2Fjournal.pmed.1000100
Kuller LH, Goldstein BD. Suggestions for STROBE recommendations. Epidemiology 2007; 18 (6):792-793
MacMahon B, Weiss NS. Is there a dark phase of this STROBE? Epidemiology 2007; 18 (6):791
Mann H. Research ethics committees and public dissemination of clinical trial results. Lancet 2002; 360(9330):406-408
Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009; 302:977-84
Miller FG, Rosenstein DL. Reporting on ethical issues in publications of medical research. The Lancet 2002; 360: 1326-1328 http://download.thelancet.com/pdfs/journals/0140-6736/PIIS0140673602113468.pdf
Moher D et al. The CONSORT Statement: revised recommendations for improving the quality of reports for parallel-group randomized trials. JAMA 2001; 285(13)1987-1991
Moher D, Liberati A, Tetzlaff J, Altman DG, for the PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009; 339:332-6 and also PLoS Medicine 2009; 6(7): e1000097 http://www.igh.org/Cochrane/PRISMA.pdf
Peiró S. ¿Se puede confiar en los resultados de la investigación clínica? Humanitas, Humanidades Médicas 2006 (5):11-24 http://www.fundacionmhm.org/www_humanitas_es_numero5/papel.pdf
Piaggio et al. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT Statement. JAMA 2006; 295:1152-1160
Pocock S, Travison T, Wruck LM. How to interpret figures in reports of clinical trials. BMJ 2008; 336:1166-1169.
Reveiz L, Cardona AF, Ospina EG, de Aguiar S. An e-mail survey identified unpublished studies for systematic reviews. J Clin Epidemiol. 2006;59(7):755-8.
Ross et al Guest authorship and ghostwriting in publications related to rofecoxib. JAMA 2008; 299:1800-1812
Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2008 Nov 25;5(11):e217; discussion e217
Rothman KJ, Poole C. Some guidelines on guidelines, They should come with expiration dates. Epidemiology 2007; 18(6): 794-796
Schiedermayer D, Siegler M. Believing what you read; responsibilities of medical authors and editors. Archives of Internal Medicine 1986; 146:2043-2044
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332
Sridharan L, Greenland P. Editorial policies and publication bias: the importance of negative studies. Arch Intern Med. 2009;169(11):1022-23 http://archinte.ama-assn.org/cgi/content/full/169/11/1022
Sutton AJ, Duval SJ, Tweedie RL, Abrams KR, Jones DR. Empirical assessment of effect of publication bias on meta-analyses. BMJ. 2000;320:1574-7
Tuma RS. New law may be having some effect on publication bias. JNCI 2010; 102(5):290-292
Tuner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy NEJM 2008; 358:252-60
Vandenbroucke JP. The making of STROBE. Epidemiology 2007; 18 (6):797-799
Vandenbroucke JP et al. Strengthening the reporting of observational studies in epidemiology (STROBE). Explanation and elaboration. 2007; 18 (6):805-835 Traducido al castellano en Mejorar la comunicación de estudios observacionales en epidemiología (STROBE): explicación y elaboración. Gac Sanit. 2009;23:158.e1-158.e28.
Von Elm E et al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement. Epidemiology 2007; 18(6): 800-804
Von Elm E, Röllin A, Blümle A, Huwiler K, Witschi M, Egger M. Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly. 2008;138(13-14):197-203
Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet 2004;24:363(9418):1341-5.
Zwarenstein M et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337:1223-6.
