[Minutes, Advisory Committee to the Director GP-160 Meeting (1992: Bethesda, Maryland)]

136

1 We would want to require standard of care
2 procedures only, whatever doctors need to do to manage
3 their patients and nothing extra, minimal data
4 collection, and simple, easily documented clinical
5 endpoints.
6 Next. We have a fairly extensive history
7 of very successful large, simple trials, primarily in
8 cardiovascular disease, that have been done in Europe.
9 I've listed some of them on this slide.
10 The International Studies of Infarct
11 Survival and the GISSI studies that were done in Italy
12 have been reported starting from the mid 1980s and
13 have randomized 12,000 to over 40,000 patients and
14 have been responsible for defining very, very
15 impottant, optimal therapeutic strategies for
16 treatment of patients with myocardia infarction.
17 In this country, the physicians' health
18 study is a large study of 22,000 physicians that's
19 looking at the question of aspirin for prevention of
20 heart disease and beta carotene for prevention of
21 cancer. There's already been preliminary information
22 from that.
NEAL R. GROSS
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