Literature DB >> 23295999

Poor definitions threaten drug trial safety in India.

Nupur Chowdhury1.   

Abstract

India has become a hotbed of clinical trials, but recent reports of safety lapses have prompted calls for better regulation in this area. Currently, trial requirements can be relaxed if doing so is in the 'public interest', but a clearer definition of what this means is needed before this provision should be used.

Mesh:

Year:  2013        PMID: 23295999     DOI: 10.1038/nm0113-15

Source DB:  PubMed          Journal:  Nat Med        ISSN: 1078-8956            Impact factor:   53.440


  2 in total

1.  Clinical Research Environment in India: Challenges and Proposed Solutions.

Authors:  Tal Burt; Pooja Sharma; Savita Dhillon; Mukul Manchanda; Sanjay Mittal; Naresh Trehan
Journal:  J Clin Res Bioeth       Date:  2014-11-01

2.  Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research.

Authors:  Tal Burt; Yogendra K Gupta; Nalin Mehta; Nagendra Swamy; Marjorie A Speers
Journal:  J Clin Res Bioeth       Date:  2014-09-07
  2 in total

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