DCGI halts a Wyeth clinical trial in India

In a knee jerk reaction, DCGI halts a Wyeth clinical trial in India. Probably the after effect of much-hyped AIIMS clinical trial fiasco.

Wyeth was testing their new pneumococcal vaccine (which covers more strains than the existing one, i.e. 12 Vs 7) in infants through a CRO based in Hyderabad. An infant in Bangalore site ( a medical college hospital) supposedly in control arm of the study died during the trial. It is now known that the infant had associated cardiac anomaly. Now the question is why the inclusion and exclusion criteria were not followed strictly? How this particular patient was included in the study in spite of a comorbid condition? Did Wyeth/CRO give protocol waiver for this?

Whom to blame in this tricky situation is not yet clear. Sponsor, CRO, or Principal Investigator? There is a clear indication of blame-game. Its gonna be interesting. I will come back with the updates.


Read the details here: Wyeth drug tests fall foul of watchdog

Blogger responses

Pharmalot writes India halts Wyeth vaccine trial over infant death

'Research Ethics Blog' posts 'Indian Vaccine trial halted over infant death'

1 comments:

  1. Fda Pharmaceutical says
    5/16/2009 6:22 PM  

    Thanks for this good post.....