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Saturday, April 4, 2009

Outsourcing clinical trials-Implications of the Globalization of Clinical Research

Economics of clinical trials

The shift towards conducting trials in eastern Europe, South America, India and China is related to issues of costs and regulatory hurdles, which have become intertwined.

  • Labor costs (physicians, nurses and coordinators) can be up to 90% lower outside the US
  • costs associated with the time required to recruit participants and conduct a trial are reduced by the availability of large pools of potential participants
  • regulatory barriers to performing clinical trials in North America and western Europe are becoming increasingly bureaucratic and expensive

Benefits of conducting trials in developing countries

  • cost-efficient evaluations of efficacy and safety of drugs or devices
  • fostering global relationships among clinicians, and between clinicians and industry.
  • Trials completed in lesser time

Ethical issues

the rights of trial participants may be jeopardized by "disparities in education, economics, social standing, and health care systems" if they

  • do not understand the investigational nature of the products being tested
  • do not understand the implications of placebo controls
  • receive a disproportionate financial compensation for participation
  • have limited access to alternative therapies.

Other Concerns

  • Does the trial respond to or prioritize the health needs of the country or region?
  • After the study ends, will patients have access to the best proven therapy identified by the trial, as expected by the Declaration of Helsinki?
  • Is the ethical conduct of the trial undermined by financial incentives for investigators?

Scientific issues

  • the need for transparency with regard to access to data
  • publication rights for investigators from developing countries
  • Are the results applicable to other populations with regard to genetic diversity or baseline characteristics (many patients enrolled in developing countries differ from their counterparts in developed nations in relation to disease stage or concomitant therapies)?
  • The clinical trial setting (hospital versus outpatient, academic center versus private clinic) requires scrutiny as to whether results can be extrapolated to other groups of patients.

Source: Glickman et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009 Feb 19;360(8):816-23.

Stephen B. Hanauer. Outsourcing clinical trials. Nature Reviews Gastroenterology and Hepatology 6, 191 (April 2009) doi:10.1038/nrgastro.2009.57

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