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

Métodos para investigar medicamentos y análisis de la información de ensayos clínicos

Métodos para investigar la seguridad y efectividad de medicametnos en humanos

Bren L. The advancement of controlled clinical trials. FDA Consumer magazine March-April 2007 http://www.fda.gov/fdac/features/2007/207_trials.html

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

DeMets DL. Clinical trials in the new millennium. Statistics in Medicine 2002; 21:2779-2787

Evans M. Justified deception? The single blind placebo in drug research. Journal of Medical Ethics 200 ; 26:188-193

Fierce Biotech. Adaptive trial barriers ranked in survey.5 de mayo de 2009
www.fiercebiotechit.com/story/adaptive-trial-barriers-ranked-survey/2009-05-04

Glasziou PP, Shepperd S, brassey J. Can we rely on the best trial? A comparrison of individual trials and systematic reviews. BMC Medical Research Methodology 2010; 10:23  www.biomedcentral.com/1471-2288/10/23

Gordian MA, Singh N, Zemmet RW. Why drugs fall short in late-stage trials. McKinsey Quarterly, January 4, 2007 Hay que registrarse pero se puede obtener en http://www.manyworlds.com/exploreCO.aspx?coid=CO140717513354

Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter? PLoS Medicine 2008; 5 (1) e4. http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050004

Hennekens CH, DeMets DL. The need for large-scale randomized evidence without undue emphasis on small trials, meta-analysis, or subgroup analysis. JAMA 2009; 302:2361-2

Institut Català de la Salut. Guía de Buena Práctica en la Investigación de Ciencias de la Salud. Barcelona: Institut Català de la Salut. Tal como esta en la web hay que abrir la guía en catalán y al final de esta versión está en castellano (parecería que es parte del mismo documento) http://www.gencat.cat/ics/professionals/pdf/bprecerca.pdf

Karanicolas PJ, Montori VM, Schünemann HJ, Guyatt GH. Pragmatic clinical trials: from whose perspective? ACP Journal Club 2009; 150(6):2-3

Kramer BS, Wilentz J, Alexander D, Burklow J, Friedman LM, Hodes R, Kirschesten, Patterson A, Rodgers G, Straus SE. Getting it right: being smarter about clinical trials. PLoS Medicine 2006; 3 (6) e144 http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0030144

Krumholz HM, Lee TH. Redifining quality – implications of recent clinical trials. NEJM 358:24: 2537-2539

Laupacis A, Paterson MJ, Mamdani M, Rostom A, Anderson GM. Gaps in the evaluation and monitoring of new pharmaceuticals: proposal for a different approach. Canadian Medical Association Journal 2003; 169 (11) 1167-169 http://www.cmaj.ca/cgi/reprint/169/11/1167.pdf

Pals SL, Murray DM et al. Individually randomized group treatment trials: a critical appraisal of frequently used design and analytical approaches. American Journal of Public Health 2008; 98(8): 1418-1424

Pater C. Equivalence and non-inferiority trials – Are they viable alternatives for the registration of new drugs? Business Briefing: Pharmacogenerics 2004 http://www.touchbriefings.com/pdf/955/ACFB485.pdf

Pm Farma México. Científicos expertos en el Dengue y la TB analizan los nuevos enfoques clínicos y modelos de excelencia para la investigación clínica y los estudios en las regiones endémicas, 21 de octubre de 2009

Sim I, Olasov, Carini S. An ontology of randomized controlled trials for evidence-based practice: content specification and evaluation using the competency decomposition method. Journal of Biomedical Informatics 2004; 37:108-119

Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments, Part 1: Ethical and scientific issues. Annals of Internal Medicine 2000; 133:455-63

Twaddell S. Surrogate outcome markers in research and clinical practice. Australian Prescriber 2009; 32(2): 47–50

Vandenbroucke JP. Observational research, randomized trials, and two views of medical science. PLoS Medicine 2008; 5(3):e67 http://medicine.plosjournals.org/archive/1549-1676/5/3/pdf/10.1371_journal.pmed.0050067-L.pdf

Warlow C. Advanced issues in the design and conduct of randomized clinical trials: the bigger the better? Statistics in Medicine 2002; 21:2797-2805

West SG, Duan N et al. Alternative to the randomized controlled trial. American Journal of Public Health 2008; 98(8):1359-1365

Manipulación de los datos que provienen de ensayos clínicos

Al-Marzouki S, Roberts I, Marshall T, Evans S. The effect of scientific misconduct on resutls of clinical trials. A Delphi study. Contemporary Clinical Trials, 2005; 26:331-337

Cañas M, Ugalde A, Orchuela J, Homedes N. “Las secuelas del rofecoxib” en la Sección Investigaciones del Boletin Fármacos 2005;8(2).

Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-1408.

Curfman GD, Morrissey S, Drazen JM (2005). “Expression of concern: Bombardier et al., “Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis,””. N. Engl. J. Med. 353 (26): 2813–4

Curfman GD, Morrissey S, Drazen JM (2006). “Expression of concern reaffirmed”. N. Engl. J. Med. 354 (11): 1193.

Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW. Ghost authorship in industry-initiated randomised trials. PLoS Med. 2007;4(1):e19. [PubMed]

Hemos leído.com Datos clínicos en investigación: la balanza entre la salud y el negocio. 14 de agosto de 2009
www.hemosleido.es/?p=714

Psaty BM and Kronmal RA, Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive, JAMA 2008;299(15): 1813-1817

Ross JS et al., Guest Authorship and Ghostwriting in Publications Related to Rofecoxib. A Case Study of Industry Documents From Rofecoxib Litigation, JAMA 2008;299(15):1800-1812.

Topol E. Failing the Public Health — Rofecoxib, Merck, and the FDA. NEJM 2004; 351:1707-1709

Topol EJ, Falk GW. A coxib a day won’t keep the doctor away. Lancet 2004;364:639-640

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

Métodos y análisis de la información que proviene de ensayos clínicos

Butlletí Groc. Evaluación de la eficacia de los tratamientos. Butlletí Groc, julio-diciembre 2008

http://www.icf.uab.es/informacion/boletines/bg/bg213.08e.pdf

Califf RM. Simple principles of clinical trials remain powerful. JAMA 2005; 293(4):489-491 (doi:10.1001/jama.293.4.489) http://jama.ama-assn.org/cgi/content/full/293/4/489

Chan AW, Hróbjartsson A, Jorgensen KJ, Gotzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomized trials: comparison of publications with protocols. BMJ 2008; 337:1404-7

Charles P, Giraudeau B, Dechartres A, baron G, Ravaud P. Reporting of sample size calculation in randomised controlled trials: review. BMJ 2009; 338:1256-9

Galea S, Tracy M. Participation rates in epidemiologic studies. AEP 2007; 9:643-653. http://deepblue.lib.umich.edu/bitstream/2027.42/55491/1/galea_participation%20rates_2007.pdf

Galende Domínguez I. ICH E9: principios estadísticos en ensayos clínicos. ICB 2000; 35:17-24 http://www.icf.uab.es/icbdigital/pdf/boletines/icb3500.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

Glasziou PP, Shepperd S, brassey J. Can we rely on the best trial? A comparrison of individual trials and systematic reviews. BMC Medical Research Methodology 2010; 10:23 www.biomedcentral.com/1471-2288/10/23

Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter? PLoS Medicine 2008; 5 (1) e4. http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050004

Heneghan C, Perera R, Ward AA, Fitzmaurice D, Meats E, Glasziou P. Assessing differential attrition o clinical trials: self-monitoring of oral anticoagulation and type II diabetes. BMC Medical Research Methodology 2007;7:18 http://www.biomedcentral.com/1471-2288/7/18

Kramer BS, Wilentz J, Alexander D, Burklow J, Friedman LM, Hodes R, Kirschesten, Patterson A, Rodgers G, Straus SE. Getting it right: being smarter about clinical trials. PLoS Medicine 2006; 3 (6) e144 http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0030144

Lipkovich I, Adams DH, Mallinckrodt C, Faries D, Baro DA, Houston JP. Evaluating dose-response from flexible dose clinical trials. BMC Psychiatry http://www.biomedcentral.com/content/pdf/1471-244X-8-3.pdf

López S, Tebé C. Tamaño muestral: entre el error, la variabilidad y el efecto. Informatiu AATRM. 2008; 43:18-20

Nüesch E, Trelle S, Reichenbach S, Rutjes AW, Büegi E, Scherer M, Altman DG, Jüni P. The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study. BMJ 2009; 339:b3244

Sim I, Olasov, Carini S. An ontology of randomized controlled trials for evidence-based practice: content specification and evaluation using the competency decomposition method. Journal of Biomedical Informatics 2004; 37:108-119

Suissa S. Calculation of number needed to treat. NEJM 2009; 361:424-5

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/1471-2288/8/12

Warlow C. Advanced issues in the design and conduct of randomized clinical trials: the bigger the better? Statistics in Medicine 2002; 21:2797-2805

Yusuf S. Randomized clinical trials: slow death by a thousand unnecessary policies. CMAJ 2004; 171 (8): 889-891 http://www.cmaj.ca/cgi/content/full/171/8/889

Yusuf S, Bosch J, Devereaux PJ et al. Sensible guidelines for the conduct of large randomized trials. Clin Trials 2008; 5:38 doi:10.1177/1740774507088099 http://ctj.sagepub.com/cgi/pdf_extract/5/1/38

Placebos

Carné Cladellas FX. Uso de placebos en ensayos clínicos. Humanitas, humanidades médicas. 2006; 7:1-10 http://www.fundacionmhm.org/tema067/articulo.pdf

Derivan AT, Bennett LLL, March J, Walraich M, Zito JM. The ethical use of placebo in clinical trials involving children. Journal of Child and Adolescent Psychopharmacology 2004; 14(2): 169-174

Emanuel EJ, Miller FG. The ethics of placebo-controlled trials. A middle ground. NEJM 2001; 345(12):915-919. http://content.nejm.org/cgi/content/extract/345/12/915

Evans M. Justified deception? The single blind placebo in drug research. Journal of Medical Ethics 2000; 26:188-193

Frank E, Novick DM, Kupfer DJ. Beyond the question of placebo controls: ethical issues in psychopharmacological drug studies. Psychopharmacology 2003; 171:19-26

Kottow Lang M El uso de placebos en estudios clínicos comunitarios: consideraciones éticas. Cuadernos Médico Sociales (Chile) 2009; 49-2:94-100
www.colegiomedico.cl/Portals/0/files/biblioteca/publicaciones/cuadernos/49_2.pdf

Larkin M. US Food and Drug Administration defends use of placebo-controlled trials. The Lancet 2008; 356:1086

Lewis JA, Jonsson B, Kreutz G, Sampaio C, Zwieten-Boot B. Placebo-controlled trials and the Declaration of Helsinki. The Lancet 2002; 359:1337-1340

Stang A, Hense HW et al. Is it always unethical to use a placebo in a clinical trial? PLoS Medicine 2005; 2(3) e72. http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020072

modificado el 28 de Noviembre de 2013


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