InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
Subscribe Login/Register
S&P 500
5,127.79
(
1.26%
)
US TECH 100
17,446.00
(
2.17%
)
Dow Jones
38,675.68
(
1.18%
)
Brent Oil
82.77
(
0.00%
)
Bitcoin
63,099.27
(
0.33%
)
Post# of 333
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Keep Next 10 Report Keyboard Shortcuts
Next 10 Prev Next

Aiming4

Send PM Follow Ignore
Followers 16
Posts 4127
Boards Moderated 2
Alias Born 07/22/2004

Aiming4

Re: ruengies3 post# 301

Friday, 04/20/2007 8:32:13 AM

Friday, April 20, 2007 8:32:13 AM

Post# of 333
Ruengies - here's the link I was remembering regarding the explanation of "pivotal trial"

http://www.adisinsight.com/aClientServiceinfo/RDI%20Phases%20of%20Dev.pdf

To be considered pivotal, a study must meet at least the following 4 FDA-defined criteria:

Be controlled using placebo or a standard therapy.

Have a double-blinded design when such a design is practical and ethical.

Be randomized.

Be of adequate size. Study sample size is a common clinical trial design flaw.


#Board-3252

Public Reply Private Reply New Post
Keep Last Read
Keep Last Read Next 10 Report Keyboard Shortcuts
Next 10 Prev Next

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.

Sign Up