Literature DB >> 29305633

[Globalization in medical research].

H-J Ehni1, U Wiesing2.   

Abstract

The globalization of clinical research is gaining momentum. In particular, emerging countries, such as Brazil, India, Russia and South Africa show a significant increase in clinical trials. This trend is generating various ethical problems, which are examined in the present article. Sometimes, generally accepted ethical rules, such as the evaluation of clinical trials by ethics commissions are not respected and sometimes conflicts are generated which are difficult to resolve. For instance, it is controversial which standard of care researchers and sponsors have to provide in an international study. These conflicts are exacerbated by a fundamental dilemma: more research on diseases prevalent in developing and emerging countries is necessary. At the same time, the protection of study participants in those countries creates particular challenges. In recent years, international commissions and guidelines have achieved significant progress in solving these conflicts; however, the further development has to be analyzed very carefully. Incentives for better research on neglected diseases have to be created. Undesirable developments and abuse have to be prevented by appropriate international ethical standards.

Entities:  

Keywords:  Developing countries; Fairly distributed benefits; International guidelines; Research ethics; Standard of care

Mesh:

Year:  2018        PMID: 29305633     DOI: 10.1007/s00104-017-0570-5

Source DB:  PubMed          Journal:  Chirurg        ISSN: 0009-4722            Impact factor:   0.955


  11 in total

Review 1.  Moral standards for research in developing countries: from "reasonable availability" to "fair benefits".

Authors: 
Journal:  Hastings Cent Rep       Date:  2004 May-Jun       Impact factor: 2.683

2.  The globalization of clinical trials: a growing challenge in protecting human subjects: executive summary (2001).

Authors: 
Journal:  J Int Bioethique       Date:  2003 Mar-Jun

3.  The standard of care debate: the Declaration of Helsinki versus the international consensus opinion.

Authors:  R K Lie; E Emanuel; C Grady; D Wendler
Journal:  J Med Ethics       Date:  2004-04       Impact factor: 2.903

4.  Research at the auction block: Problems for the fair benefits approach to international research.

Authors:  Alex John London; Kevin J S Zollman
Journal:  Hastings Cent Rep       Date:  2010 Jul-Aug       Impact factor: 2.683

5.  Global notes: the 10/90 gap disparities in global health research.

Authors:  D Vidyasagar
Journal:  J Perinatol       Date:  2006-01-01       Impact factor: 2.521

6.  Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries.

Authors:  P Lurie; S M Wolfe
Journal:  N Engl J Med       Date:  1997-09-18       Impact factor: 91.245

7.  Ethical complexities of conducting research in developing countries.

Authors:  H Varmus; D Satcher
Journal:  N Engl J Med       Date:  1997-10-02       Impact factor: 91.245

Review 8.  Do surgical trials meet the scientific standards for clinical trials?

Authors:  Danielle M Wenner; Baruch A Brody; Anna F Jarman; Jacob M Kolman; Nelda P Wray; Carol M Ashton
Journal:  J Am Coll Surg       Date:  2012-07-21       Impact factor: 6.113

9.  Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011-2013.

Authors:  Sohyun Jeong; Minji Sohn; Jae Hyun Kim; Minoh Ko; Hee-Won Seo; Yun-Kyoung Song; Boyoon Choi; Nayoung Han; Han-Sung Na; Jong Gu Lee; In-Wha Kim; Jung Mi Oh; Euni Lee
Journal:  Trials       Date:  2017-06-21       Impact factor: 2.279

10.  Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

Authors:  Ignacio Atal; Ludovic Trinquart; Raphaël Porcher; Philippe Ravaud
Journal:  PLoS One       Date:  2015-12-14       Impact factor: 3.240

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  1 in total

1.  Patient Benefit of Clinical Research in Diversely Advanced African Developing Countries.

Authors:  Vanessa Strüver; Sheraz Ali; Firas Fneish; Gerhard Fortwengel
Journal:  Curr Ther Res Clin Exp       Date:  2021-11-24
  1 in total

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