Inquiry into vaccine trial in India suggests ineffective oversight

BMJ 2009; 338 doi: (Published 08 April 2009) Cite this as: BMJ 2009;338:b1418
  1. Ganapati Mudur
  1. 1New Delhi

    An inquiry by the Indian government into the death of an infant during a clinical trial of an investigational vaccine has indicated deficiencies in the supervision of the trial, rekindling concerns about standards of scrutiny of clinical trials in India.

    A two member panel appointed by the drugs controller general of India has determined that the infant who died at the St John’s Hospital in Bangalore had a pre-existing medical condition and should have been excluded from the trial of an investigational pneumococcal vaccine manufactured by Wyeth.

    The controller had stopped the trial in November 2008 and launched an investigation after the death.

    Wyeth, the company that manufactured the vaccine and GVK Biosciences, the local monitor of the trial, have pointed out that the infant did not receive the investigational vaccine, but was randomised to receive a reference product already …

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