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

Grupos involucrados en la realización de ensayos clínicos

Agencias reguladoras y ensayos clínicos

EMEA to inspect clinical trials in “third” countries” Scrip News, 27 de febrero de 2009

EE.UU. Departamento de Salud y Servicios Humanos. Oficina del Inspector General. The FDA’s Oversight of Clinical Investigators’ Financial Information. Enero 2009 OEI-05-07-00730 44 páginas.
oig.hhs.gov/oei/reports/oei-05-07-00730.pdf

EE.UU. Departamento de Salud y Servicios Humanos. Oficina del Inspector General. Oversight of Clinical Investigators. Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators. Semptember 2009. GAO-09-807 http://www.gao.gov/products/GAO-09-807

Evans D, Smith M, Willen L. Human guinea pigs pay for lax FDA rules. The Seattle Times, November 6, 2005. http://seattletimes.nwsource.com/html/businesstechnology/2002606640_drugtesting06.html Traducido en Boletin Farmacos 2005; 8 (5) http://www.saludyfarmacos.org/boletin-farmacos/boletines/nov2005/etica-y-medicamentos

GAO. Oversight of Clinical Investigators, September 2009. Está disponible en www.gao.gov/new.items/d09807.pdf

Huff E. FDA openly allows criminally-convicted doctors, researchers to keep working on pharmaceuticals and clinical trials. Natural News, 19 noviembre de 2009
carolinamtnwoman.wordpress.com/2009/11/20/fda-openly-allows-criminally-convicted-doctors-researchers-to-keep-working-on-pharmaceuticals-and-clinical-trials/

Hurley D et al Latin American clinical trial authorizations, Focus.indd, junio de 2009 http://www.kendle.com/uploads/llpLatAm_Clin_Trials_Article.pdf

Kalberg JPE US FDA Site Inspection Findings, 1997-2008, Fail to Justify Globalization Concerns.
Clinical Trial Magnifier 2009; 2(4): 194-212 www.ClinicalTrialMagnifier.com

O’Connor AB. The need for improved access to FDA reviews JAMA 2009; 302 (2):191-193

Tanne JH European and US. agencies will cooperate to ensure ethical conduct of trials, BMJ 2009;339:b3274 www.bmj.com/cgi/content/full/339/aug10_2/b3274

Comunidad y ensayos clínicos

Benson PR. The social control of human biomedical research: an overview and review of the literature. Social Science and Medicine 1989; 29(1): 1-12

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

Corneli AL, Piwoz EG, Bentley ME et al for the UNC Project BAN study team. Involving communities in the design of clinical trial protocols: the BAN study in Lilongwe, Malawi. Contemporary Clinical Trials 2007; 28:59-67

Dickert N, Sugarman J. Ethical goals of community consultation in research. AJPH 2005; 95(7): 1123-7

Dix ES, Esposito D, spinosa F, Olson N, Chapman S. Implementation of Community consultation for waiver of informed consent in emergency research: One Institutional Review Board’s experience. Journal of Investigative Medicine 2004; 52(2):109-112

Ernst A, Fish S. Exception from informed consent: Viewpoint of institutional review boards- balancing risks to subjects, community consultation, and future directions. Academic Emergency Medicine 2005; 12(11): 1050-1055

Fleischhacker S, Cohen M. The ABCs of Drug Safety: Accountability, Balance and Citizen Empowerment. A Roadmap for Conducting Credible Clinical Drug Trials and Protecting Drug Trial Participants.
The Government Accountability Project. Abril 2009.  www.whistleblower.org/doc/2008/ABCFinal040709.pdf

Glass KC, Kaufert J. Reserch ethics review and aboriginal community values: can the two be reconciled? Journal for Empirical Research on Human Research Ethics 2007; 2 (2): 25-40

Hussain-Gambles M. South Asian patients’ views and experiences of clinical trial participation. Family Practice 2004; 21(6): 636-642

Lairumbi GM, Molyneux S, Snow RW, Marsh K, Peshu N, English M. Promoting the social value of research in Kenya: examining the practical aspects of collaborative partnerships using an ethical framework. Social Science and Medicine 2008; 67(5): 734-747

MacQueen KM, McLoughlin K, Alleman P, burke HM, Mack N. Partnering for care in HIV prevention trials. Journal of Empirical Research and Human Research Ethics 2008; 3(4): 5-18

Madsen et al. Ethical aspects of clinical trials: the attitudes of the public and out-patients. Journal of Internal Medicine 1999; 245:571-579.

Madsen et al. Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. Journal of Internal Medicine 2000; 248:463-474.

Madsen et al. Attitudes towards clinical research amongst participants and nonparticipants. Journal of Internal Medicine 2002; 251:156-168.

Marsh V, Kamuya D, Rowa Y, Gikonyo C, Molyneux S. Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kifili, Kenya. Social Science and Medicine 2008; 67(5): 721-733

Mattson ME, Curb JD, McArdle R & Amis and Bhat Research Groups. Participation in a clinical trial: the patient’s point of view. Controlled Clinical Trials 1985; 6(2):156-167

Silva J. Relevancia social na pesquisa clinica Revista Bioética 2007; 15(1): 133-140

Strauss RP, Sengupta S, Quinn SC, Goeppinger J. The role of community advisory boards: involving communities in the informed consent process. AJPH 2001; 91(12):1938-43

Sugarman J, Kass NE, Goodman SN, Perentesis P, Fernandes P, Faden RR. What patiens say about medical research. IRB: Ethics and Human Research 1998; 20(4):1-7

Velasco Zamora, J.¿Qué dicen los pacientes? Revista Fecicla 2008;1:6 www.fecicla.org

Wendler D, Kington R, Madans J, Van Wye G, Christ-Schmidt H, Pratt LA et al. Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine 2006; 3(2):1-10

Yarborough M, Sharp RR. Bioethics consultation and patient advocacy organizations: Expanding the dialogue about professional conflicts of interest. Quarterly of Healthcare Ethics 2006; 16:74-81

Centros médicos y ensayos clínicos

Angell M. Academic Medicine for sale? NEJM 2000; 342:1516-1518

Blumenthal D. Ethics issues in academic-industry relationships in the life sciences: The continuing debate. Academic Medicine 1996; 17 (71): 1291-1296

Blumenthal D, Campbell EG, Causino H, Louis K. Participation of life-science faculty in research relationships with industry. NEJM 1996; 335:1734-1739

Blumenthal D, Causino N, Campbell EG, Louis K. Relationships between academic institutions and industry in the life sciecnes: An industry survey. NEJM 1996; 334(6):368-373

Boyd EA, Bero L. Assessing the faculty financial relationships with industry. JAMA 2000; 284 (17):2209-2214

Campbell EG, Moy B, Feibelmann S, Weissman JS, Blumenthal D. Institutional academic industry relationships: results of interviews with university leaders. Accountability in Research 2004; 11:103-118

Healy D. Conflicting interests in Toronto: anatomy of a controversy at the interface of academia and industry. Perspectives of Biology and Medicine 2002; 45(2):250-263

Mello MM, Clarridge BR, Studdert D. Academic medical centers’ standards for clinical trail agreements with industry. NEJM 2005; 352 (21): 2202-10 http://content.nejm.org/cgi/reprint/352/21/2202.pdf

Sugarman J. The role of institutional support in protecting human research subjects. Adacemic Medicine 2000; 75(7):687-692

Weinfurt KP, Dinan MA, Allsbrook JS, Friedman JY, Hall MA, Schulman KA, Sugarman J. Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants. Academic Medicine 2006; 81(2):113-118

Weissman JS, Saglam D, Campbell EG, Causino N, Blumenthal D. Market forces and unsponsored research in academic health centers. JAMA 1999; 281(12):1093-1098

Conflictos de interés y ensayos clínicos (generales)

Barnes M, Florencio Ps. Investigator, IRB and institutional conflicts of interest in human-subject research: Past, present and future. Seton Hall Law Review 2003; 32(3): 525-560

Bekelman EJ, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: A systematic review. JAMA 2003; 289: 454 – 465

Blumenthal D, Campbell EG, Causino N, Louis K. Participation of life-science faculty in research relationships with industry. NEJM 1996; 335(23): 1734-1739

Bodenheimer T. Uneasy alliance: clinical investigators and the pharmaceutical industry. NEJM 2000; 342(20:1539-1544

Bodenheimer Thomas. Clinical investigators and the Pharmaceutical Industry. N Engl J Med. 2000;342(20):1539-1544.

Campbell EG, Weissman JS, Vogeli C, Clarridge BR, Abraham M, Marder JE et al. Financial relationships between institutional review board members and industry. NEJM 2005; 355 (22):2321-2329

CREMESP. Conflicto de interesses em pesquisa clínica. Sao Paulo:Conselho Regional de Medicina do Estado de Săo Paulo. Cadernos de Bioética do CREMESP 2007.

Davidoff F, De Angelis CD, Drazen JM, Hoey J, Hjgaard L, Horton R, et al. Sponsorship, authorship and accountability. Lancet. 2001; 358:854-6.

DeAngelis CD. Conflict of interest and the public trust. JAMA 2000; 284(17):2237-2238

De Vries R, Anderson MS, Martinson. Normal misbehavior: scientists talk about the ethics of research. The Journal of Empirical Research Ethics 2006:43-50 http://caliber.ucpress.net/loi/jer?cookieSet=1

Fisher JA. Practicing research ethics: private-sector physicians and pharmaceutical clinical trials. Social Science and Medicine 2008; 66(12):2495-2505

Gardner W, Lidz CW. Research sponsorship, financial relationships, and the process of research in pharmaceutical clinical trials. Journal of Empirical Research on Human Research Ethics 2006: 11-18 http://caliber.ucpress.net/loi/jer?cookieSet=1

Hampson LA, agrawal M, Joffe S, Gross CP, Verter J, Emanuel EJ. Patients’ views on financial conflicts of interest in cancer research trials. NEJM 2006; 355(22): 2330-2337

Hurst SA, Mauron A. A question of method. The ethics of managing conflicts of interest. EMBO reports 2008; 9(2): 119-123 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2246405

Kao AC, Green DC, Zaslavsky AM, Koplan JP, cleary PD. The relationship between method of physician payment and patient trust. JAMA 1998; 280 (19):1708-1714

Kimmelman J. Inventors and investigators: the ethics of patients in clinical trials. Academic Medicine 2007; 82 (1): 24-31

Kunin CM. Clinical investigators and the pharamceutical industry. Annals of Internal Medicine 1978; 89:842-845.

Lemmens T. Piercing the veil of corporate secrecy about clinical trials. Hastings Center Report 2004; 34 (5): 14-18

Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical sponsorship and research outcome and quality: systemic review. BMJ. 2003;326(7400):1167-70.

Lewis TR, Reichman JH, So AD. The case for public funding and public oversight of clinical trials. Economists’ Voice. 2007; 4 (1)/ http://www.bepress.com/ev/vol4/iss1/art3/

Morin K, Rakatansky H et al. Managing conflicts of interest in the conduct of clinical trials. JAMA 2002; 287:78-84

Reed DA, Cook DA, Beckman TJ, Levine RB, Kern DE, Wright SM. Association between funding and quality of published medical education research. JAMA. 2007; 298:1002-9.

Steinbrock R. Controlling conflict of interest- proposals from the Institute of Medicine. NEJM 2009; 360:2160-3

Studdert David M, Mello Michelle M, Phil M, Brennan, Troyen A. Financial Conflicts of Interest in Physicians’ Relationships with the Pharmaceutical Industry Self-Regulation in the Shadow of  Federal Prosecution. N Engl J Med. 2002;351(18):1891-1900

Yarborough M, Sharp RR. Bioethics consultation and patient advocacy organizations: Expanding the dialogue about professional conflicts of interest. Quarterly of Healthcare Ethics 2006; 16:74-81

Zoboli E, Oselka G. Conflicto de interesses na pequisa clínica. Revista Bioética 2007; 15 (1): 65-76

Contratos y ensayos clínicos

DeRenzo EG. Coercion in the recruitment and retention of human research subjects, pharmaceutical industry payments to physician-investigators, and the moral courage of the IRB. IRB 2000; 22(2):1-5

Fisher JA. Practicing research ethics: private-sector physicians and pharmaceutical clinical trials. Social Science and Medicine 2008; 66(12): 2495-2505. doi: 10.1016/j.socsimed.2008.02.001 http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18353515

Gardner W, Lindz CW, Hartwig KC. Authors; reports about research integrity problems in clinical trials. Comtemporary Clinical Trials 2005; 26(2):244-251

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

Kassirer JP, Angell M. Financial conflicts of interest in biomedical research. NEJM 1993;329(8):570-571

Silversides A. Clinical trial participation poses ethical, practical issues. CMAJ 2009; 180(5): 500-502. http://www.cmaj.ca/cgi/content/full/180/5/500

Weinfurt KP, Hall MA, King N, Friedman JY, Schulman KA, Sugarman J. Disclosure of financial relationships to participate in clinical research. NEJM 2009; 361:916-921.

CROs (Contract Research Organizations)

Akst J. Contract research on the rise The Scientist: Newsblog, 5 de agosto, 2009
www.the-scientist.com/blog/print/55878

Dietlin T. From vendor to partner: changing the dynamic between CROs and frug developers. Foresight and INC Resarch Publication, febrero 2010. www.incresearch.com

Evans D, Smith M, Willen L. Human guinea pigs pay for lax FDA rules. The Seattle Times, 6 de noviembre, 2005. http://seattletimes.nwsource.com/html/businesstechnology/2002606640_drugtesting06.html Traducido en Boletín Fármacos 2005; 8 (5) http://www.saludyfarmacos.org/boletin-farmacos/boletines/nov2005/etica-y-medicamentos

Mirowski P and Van Horn R. The contract research organization and the commercialization of scientific research. Social Studies of Science 2005; 35/4: 503-548

Murphy J. Communication is key to Almac’s succesful partnerships. 7th Annual Partnerships in Clinical Trials 2008. Scrip News Supplement. www.scripnews.com/supplements 2008: 16-17

Petryna A. Clinical trials offshored: on private sector science and public health. Biosciences 2007; 2:21-40

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. Exit task in-sourcing, enter comprehensive outsourcing. Scrip 100; 2008:101-104. www.scripnews.com/supplements

Shuchman M. Commercializing clinical trials- risks and benefits of the CRO Boom. NEJM 2007; 357(14):1365-1368 http://content.nejm.org/cgi/content/extract/357/14/1365

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

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

Zhao L. The China Connection. 7th Annual Partnerships in Clinical Trials 2008. Scrip News Supplement. www.scripnews.com/supplements 2008:21-22

Farmacias y ensayos clínicos

The Institute of Clinical Research and The Royal Pharamceutical Society of Great Britain. Practice guidance on pharmacy services and clinical trials. June 2005  http://www.rpsgb.org.uk/pdfs/clinicaltrialsguid.pdf

Gobiernos y ensayos clínicos

Bestow LM, Dame L, Costello EJ. Certificates of confidentiality and compelled disclosure of data. Science 2008; 322(5904): 1054-1055

Institutos nacionales/grupos cooperativos de investigación y ensayos clínicos

Andersen M, Kragstrup J, Sondergaard J. How conducting a clinical trial affects physicians’ guideline adherence and drug preferences. JAMA 2006; 295 (23): 2759-2764. http://jama.ama-assn.org/cgi/reprint/295/23/2759?ijkey=9406f29794e4f4273e5f0f1eee6838528828b3b8

Lexchin J, Bero LA, Djulbegovic B, Clark O. Clinical trial investigators and their prescribing patterns: another dimension to the relationship between physician investigators and the pharmaceutical. BMJ 2003;326:1167-1170  http://www.bmj.com/cgi/reprint/326/7400/1167

Psaty BM, Rennie D. Clinical trial investigators and their prescribing patterns. Another dimension to the relationship between physician investigators and the pharmaceutical industry (Editorial). JAMA 2006; 295(23): 2787-2790

Industria farmacéutica y ensayos clínicos

Campbell EG, Weissman JS, Vogeli C, Clarridge BR, Abraham M, Marder JE et al. Financial relationships between institutional review boeard members and industry. NEJM 2005; 355 (22):2321-2329

Epstein RA. Influence of pharmaceutical funding on the conclusions of meta-analysis BMJ 2007; 335:1167

Goldacre B, Lawton V. Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? BMJ 2009; 339:1286-7

Kunin CM. Clinical investigators and the pharmaceutical industry. Annals of Internal Medicine 1978; 89:842-845.

Lemmens T. Piercing the veil of corporate secrecy about clinical trials. Hastings Center Report 2004; 34 (5): 14-18

Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical Sponsorship and Research Outcome and Quality: Systemic Review. BMJ. 2003;326(7400):1167-70.

Peralta V. Ensayos clínicos, industria farmacéutica y práctica clínica. Boletín de información y farmacoterapeútica de Navarra 2005; 13 (4): 30-34. http://www.cfnavarra.es/webgn/sou/publicac/bj/textos/Bit_v13n4.pdf

Ynak V, Rennie D, Bero LA. Financial ties and concordance between results and conclusions in metaanalyses: retrospective cohort study. BMJ 2007; 335:1202-5

Sistemas públicos de salud y ensayos clínicos

Universidades y ensayos clínicos

Berendt L, et al. Effect of European clinical trials directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medical Agency, 1993-2006. BMJ 2008; doi:10.1136/bmj.39401.470648.BE

modificado el 28 de Noviembre de 2013


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