Phase 1 Drug Trials on Humans to Be Made Public

by Medindia Content Team on  May 19, 2006 at 12:39 PM Drug News
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Phase 1 Drug Trials on Humans to Be Made Public
World Health Organization (WHO) asked the pharmaceuticals companies and academic institutions to reveal all information on all clinical drug trials on humans. All drug trails including the details about Phase I trials, initial toxicity tests that were conducted on healthy humans are to be registered on independent registers as soon as they begin. Though this decision is not been made legal but it is to spark mixed reaction among the researchers.

Such measures would avoid the near fatal outcome in the UK due to the early trial of TGN1412, an experimental drug that caused six men to fall seriously ill. WHO said that due to this measure all the results of the trail whether positive or negative are to be made fully available to researchers. Even the International committee of medical journal editors resolved to consider or publish only those results from trials that had already been publicly registered.

But the International Federation of Pharmaceutical Manufacturers and Associations said that releasing information on early-stage trials could provide clues to competitors. But the WHO panel members said that those do not outweigh the benefits of disclosure. Timothy Evans, WHO assistant director-general, said that this measure would create awareness to the public. The British Medical Journal has already expressed support for such a move.


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