Salud y Fármacos

Una organización internacional sin ánimo de lucro para fomentar el acceso y el uso adecuado de medicamentos entre la población hispano-parlante

Artículos sobre ensayos clínicos y ética

Asuntos relacionados con la realización de ensasyos clínicos

Buenas prácticas clínicas

Buenas Prácticas Clínicas: Documento de las Américas. OPS.

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.

Reclutando pacientes

Francis D, Roberts I, Elbourne DR, Shakur J et al. Marketing and clinical trials: a case study. Trials 2007; 8:37

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.

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.

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

Hirji KF. No short-cut in assessing trial quality: a case study. Trials 2009; 10 (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

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

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

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

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.

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

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

London L. Ethical oversight of public health research: can rules and IRBs make a difference in developing countries? AJPH 2002; 92(7):1079-1084

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

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.

Harris G. Report assails FDA oversight of clinical trials. New York Times, 28 de septiembre, 2007

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

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

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

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.

Decullier E, et al. Inadequate dissemination of phase I trials: a retrospective cohort study. PLoS Medicine 2009; 6(2): e1000034

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

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)

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.

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

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

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.

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

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

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

Peiró S. ¿Se puede confiar en los resultados de la investigación clínica? Humanitas, Humanidades Médicas 2006 (5):11-24

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

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.

modificado el 28 de Noviembre de 2013

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