These are the best empirical data that exist on the topic
(cancer-related):
Horstmann E, McCabe MS, Grochow L, et al: Risks and Benefits of Phase 1
Oncology Trials, 1991 through 2002. N Engl J Med 352:895-904, 2005
Benjamin Djulbegovic, MD,PhD
Professor of Oncology and Medicine
H. Lee Moffitt Cancer Center & Research Institute at the University of
South Florida Department of Interdisciplinary Oncology, MRC, Floor 2,Rm#
2067H
12902 Magnolia Drive
Tampa, FL 33612
e-mail:[log in to unmask]
http://www.hsc.usf.edu/~bdjulbeg/
phone:(813)972-4673
fax:(813)745-6525
-----Original Message-----
From: Evidence based health (EBH)
[mailto:[log in to unmask]] On Behalf Of Ted Harding
Sent: Thursday, March 16, 2006 14:00
To: [log in to unmask]
Subject: Phase 1 Trials
[This will be my fifth attempt to post this to the list.
This time I am composing from scratch and copying the
body text. If it gets through, then be warned that if
you forward someone else's message to a JISCmail list
then it will
a) not reach the list;
b) be returned to the "someone else" on the grounds
that they are not subscribed to the list.
I do not know why this occurs, but such behaviour by
the listserv surely counts as a bug.]
Hi Folks,
Allan Reese posted the following on the allstat list this
morning. With his approval I am relaying it to EBH, and
will send him or point him to any replies. Or you may reply
to him directly (see below).
Best wishes to all,
Ted.
------------------------------------------------------------
>>Original date Thu, 16 Mar 2006 10:38:58 -0000
>>Originally from "Allan Reese (Cefas)" <[log in to unmask]>
Are there are public data on the frequency/severity of adverse
reactions in phase 1 drug trials?
In case the current UK headline story has not reached abroad,
the story is on the BBC website
http://news.bbc.co.uk/1/hi/england/london/4811626.stm
"It was the first time the drug TGN1412, designed to treat
conditions such as rheumatoid arthritis and leukaemia, had been
tested on humans. Within hours of taking it on Monday, the six
young volunteers had to be admitted to intensive care.
They "went down like dominoes", according to Raste Khan, 23,
one of two trial volunteers who escaped unscathed after being
given a placebo."
Allan Reese ( [log in to unmask] )
-------------------------------------------------------------
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E-Mail: (Ted Harding) <[log in to unmask]>
Fax-to-email: +44 (0)870 094 0861
Date: 16-Mar-06 Time: 18:59:29
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