Excerpt from the Tide Trial letter:
Last week we infonned you of the United States Food and Drug Administration's (FDA)
decision to place a partial clinical hold on the TIDE trial (i.e. to continue following randomized
participants but to not randomize new participants). In the letter we also infonned you that you
would receive a summary of the infonnation that was presented at the FDA Advisory Committee
Meeting on July 13 and 14,2010. As requested by the FDA, this summary document was written
by the Sponsor, GlaxoSmithKline. It has now been completed and includes the questions that
the panel voted on and the tally of the votes. It is attached to this email.
As mentioned in last week's note and as requested by the FDA, please send this document to
your local ethics committees as soon as possible for their infonnation, together with the short
cover note that you may want to modify to accompany the document. As you will recall, last
week we provided participant infonnation letters that describe the FDA meeting. However, if
you or your ethics committee feel that the current consent fonn should be modified for the
current participants, please do so. Finally, if applicable for your site, your local sponsor team will
submit this letter to the central ethics committee on your behalf. It will also provide a copy of
the document to the regulatory agency in your country according to local requirements.
As noted last week, the TIDE leadership remain committed to the relevance and appropriateness
of this trial regardless of the current controversy. We will certainly continue to keep you
infonned of any new developments. In the meantime, it remains important that the interests and
the autonomy of the study participants be paramount and that any questions that they may have
should be openly addressed.
This is the letter that went with the Glaxo letter to others.
http://www.markzamora.com/AvandiaFLA/index.html
