Vol , Issue Date of Publication: July 01, 2007
DOI: https://doi.org/10.20529/IJME.2007.048

Views
, PDF Downloads:

Lessons from the recently halted microbicide trial in India

Suneeta Krishnan
Abstract:
In January 2007, two Phase III clinical trials of a candidate microbicide among women at high risk of HIV in India, South Africa, Benin, Uganda, and Nigeria were halted. This was done because analyses of preliminary data by the Independent Data Monitoring Committee indicated that the product was associated with an increased risk of acquiring HIV. The planning, implementation, and subsequent cessation of these trials illustrate the mechanisms for protecting participants in microbicide trials in developing countries. The closure of the trials highlights the complexities of such decisions and the range of competencies that research teams must possess.


Copyright and license
©Indian Journal of Medical Ethics 2016: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0),
which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.

Full Text

HTML | PDF
Help IJME keep its content free. You can support us from as little as Rs. 500 Make a Donation