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

Información proveniente de la industria sobre ensayos clínicos/ globalización de los EC

ACRO The case for globalization: Ethical and business considerations in clinical research, 21 de Julio 2009 http://www.acrohealth.org/globalization-white-paper.html

Annas GJ. Globalized clinical trials and informed consent. NEJM 2009; 360 (20):2050-2053    http://nejm.highwire.org/cgi/content/extract/360/20/2050

 Association of Clinical Research Organizations (ACRO). CRO Market. www.acrohealth.org/cro-market1.html

ATKERNEY.  Kearney’s 2007 Global Services Location Index. Regional Highlights. http://www.atkearney.com/main.taf?p=5,3,1,160&utm_source=pr&utm_medium=atk

ATKERNEY. A.T. Kerney’s 2004 Offshore Location Attractiveness Index. http://www.atkearney.com/shared_res/pdf/Making_Offshore_S.pdf

ATKERNEY. Offshoring for long-term advantage. The 2007 A.T.Kerney Global Location Index.  http://www.atkearney.com/shared_res/pdf/GSLI_2007.pdf

Ávila Vázquez M. Globalización e identidades médicas en los ensayos clínicos. Salud Colectiva 2007; 3(3): 235-245 http://dialnet.unirioja.es/servlet/fichero_articulo?codigo=2492747&orden=0

Bailey W, Cruickshank C, Sharma N. Make your move: taking clinical trials to the best location. A.T. Kerney Executive Agenda 2006: 56-62. Consultado el 30 de junio de 2009 en http://www.atkearney.com/main.taf?p=5,1,1,116,3,1/

Bloch M, Dhankhar A, Narayanan S. Pharma leaps offshore. McKinsey and Company. Julio de 2006. web exclusive. http://www.mckinseyquarterly.com/Pharma_leaps_offshore_1787

Clark TD. The case of globalization: ethical and business considerations in clinical research. Value of Insight. July 21, 2009

Cutting Edge Information (www.cuttingedgeinfo.com). Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity. http://www.researchandmarkets.com/reports/c9378

Cutting Edge Information (www.cuttingedgeinfo.com). Streamlining Clinical Trials. Hay que registrarse para poder acceder al resumen en: http://www.cuttingedgeinfo.com/clinicaltrialbenchmarking/PH117_Download.asp#body

Cutting Edge Information. Clinical Insights Edition. Mayo 2009
www.cuttingedgeinfo.com/clinical-outsourcing-strategy/?download (require registro)

Cutting Edge Information. Clinical outsourcing strategy. Selecting partners and managing relationships. www.cuttingedgeinfo.com

David E, Tramotin T, Zemmet R. The road to positive R&D returns. McKinsey Quarterly. February 2010.

Glickman SW et al. Ethical and scientific implications of the globalization of clinical research. NEJM 2009; 360 (8): 816-823

Hanauer SB. Outsourcing clinical trials. Nature Reviews, Gastroenterology and Hepatology. 2009; 6:191

Hughes J, Varni J. Exit task in-sourcing, enter comprehensive outsourcing. Scrip 2009; 100;101-104. http://www.vantagepartners.com/uploadedFiles/Consulting/Research_And_Publications/Smart_Form_Content/Publications/Articles/Scrip100.pdf

Hurley D, Lipezker M, Melgar H, Mazzolenis D. Latin American Clinical Trials Authorizations. Overview and Update. June 2009.

Kalberg JPE. Globalization of sponsored clinical trials. Nature Reviews Drug Discovery 2008;7: 458 doi:10.1038/nrd2441-c1

Kalberg JPE. Industry clinical testing of new medicinal products requires 95.000 study sites and 1,300.000 subjects annually. Clinical Trial Magnifier 2008b; 1(6):101-109

Karlberg JPE. Uninterrupted Globalization of industry sponsored clinical trials. Clinical Trial Magnifier 2009; 2(2):79-94

Karlberg JPE. Investigator initiated trials contractual affairs. Clinical Trial Magnifier 2009; 2(5):246-260

Karlberg JPE. Industry Trials in BRIC (Brasil, Russia, India and China). – Russia, Moscow and St Petersburg Stand Out. Clinical Trial Magnifier 2009; 2(6):305-320

Kalberg JPE. What is driving the globalization process of clinical research? Clinical Trials Magnifier 2009; 2(8):396-397

Kline D. Clinical Trials in Latin America. White Paper. Data Edge. A Fast Track System. November 2001.

Medical News Today. US Drug companies conducting more clinical trials overseas to reduce costs, speed approval. Medial News Today, 18 de mayo 2005. www.medicalnewstoday.com/articles/24634.php

Peddicord D.  Regulatory infrastructure fosters globalization of drug development. Drug Discovery and Development 2010, February 16.  

Petryna A. Ethical variability: Drug development and globalizing clinical trials. American Ethnologist 2005; 32 (2): 183-197

Petryna A. Clinical trials offshored: on private sector science and public health. BioSciences 2007; 2:21-40. Borrador disponible en http://www.fas.harvard.edu/~valuesgh/docs/petryna_gh_markets.pdf

Pharmaceutical Product Development (PPD). Considerations for conducting clinical trials in Latin America. 2009  www.ppdi.com/locations/latin_america_overview/conducting_clinical_trials.htm

Pmfarma.com. El mercado de ensayos clínicos llegó a los 50.000 millones de dólares en 2008, 20 de julio de 2009. espana.pmfarma.com/noticias/noti.asp?ref=1044

RAPS Webcasts. Drug development in Latin America. Recent trends and competitive advantage. 2009

Rowland, C. Clinical trials seen shifting overseas. International Journal of Health Services 2004; 34(3): 555-556

Scrip. Scrip’s analysis of the pharmaceutical industry’s performance and proposals. August 2007. http://www.btgplc.com/PubContent/Docs/Scrip%20100%202007.pdf

Scrip. Betting on subject enrolment. Partnerships in Clinical Trials. 2008

Scrip. Latin America: Ripe for Clinical Research. Scrip News, SCRIP 100 Supplement, December 2008. http://www.kendle.com/media/media_rea2008.php

Scrip. All they’re cracked up to be? Scrip 100, diciembre de 2009: 115-117. www.scrip100.com

Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials.  Nature Reviews Drug Discovery 2007; 7, 13-14. doi:10.1038/nrd2441 News Analysis

Trevena J. The threat of the new. The CRO industry went from strength to strength in 2007, but now will those in established regions cope as the market migrates to low-cost outsourcing destinations in 2008 and beyond? In Scrip 100. pages 91-94. www.scrip100.com

Virk KP. Latin America’s Trials Climate. Applied Clinical Trials online. June 1, 2009. http://license.icopyright.net/user/viewFreeUse.act?fuid=ODg1NDQwNg%3D%3D

Value of Insight (VOI). The case for globalization: ethical and business considerations in clinical research. July 21, 2009. www.voiconsulting.com

Weissback M.  CROs: Challenging the tradition. In Scrip 100. pages 40-41. www.scrip100.com

modificado el 28 de Noviembre de 2013


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