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0o兞T鑜孮t濺誰 02 0 0 7 .
[ 2 ] A m y E . M c k e e , e t a l . T h e r o l e o f t h e U . S . F o o d a n d D r u g A d m i n i s t a t i o n R e v i e w P r o c e s s : C l i n i c a l T r i a l E n d p o i n t s i n O n c o l o g y . T h e o n c o l o g i s t 2 0 1 0 1 5 ( s u p p l 1 ) : 1 3 - 1 8
[ 3 ] F D A . G u i d a n c e f o r I n d u s t r y C l i n i c a l T r i a l E n d p o i n t s f o r t h e A p p r o v a l o f C a n c e r D r u g s a n d b i o l o g i c s . 2 0 0 7 .
[ 4 ] E M E A . G u i d e l i n e o n t h e E v a l u a t i o n o f A n t i c a n c e r M e d c i n a l
P r o d u c t s I n M a n . 2 0 0 5 .
[ 5 ] J P . G u i d l i n e s f o r c l i n i c a l e v a l u a t i o n o f a n t i - c a n c e r d r u g . 2 0 0 5 .
[ 6 ] K e i t h T . F l a h e r t y , e t a l . C o n v e n t i o n a l D e s i g n a n d N o v e l S t r a t e g i e s i n t h e E r a o f T a r g e t e d T h e r a p i e s . A n t i c a n c e r D r u g D e v e l o p m e n t G u i d e ( S e c o n d E d i t i o n ) . 2 0 0 4 , 2 6 3 - 3 8 0 .
[ 7 ] R a m z i N . D a g h e r , e t a l . T h e P h a s e I I I C l i n i c a l C a n c e r T r i a l . A n t i c a n c e r D r u g D e v e l o p m e n t G u i d e ( S e c o n d E d i t i o n ) . 2 0 0 4 , 4 0 1 - 4 1 0 .
[ 8 ] F D A . G u i d a n c e f o r I n d u s t r y A p p r o v a l o f N e w C a n c e r T r e a t m e n t U s e s f o r M a r k e t e d D r u g a n d B i o l o g i c a l P r o d u c t s . 1 9 9 8 .
[ 9 ] F D A . G u i d a n c e f o r I n d u s t r y F a s t T r a c k D r u g D e v e l o p m e n t P r o g r a m s D e s i g n a t i o n , D e v e l o p m e n t , a n d A p p l i c a t i o n R e v i e w . 2 0 0 6 .
[ 1 0 ] E M E A . G u i d e l i n e o n p r o c e d u r e s f o r t h e g r a n t i n g o f a m a r k e t i n g a u t h o r i z a t i o n u n d e r e x c e p t i o n a l c i r c u m s t a n c e s . 2 0 0 5 .
[ 1 1 ] L a w r e n c e V . R u b i n s t e i n , e t a l . D e s i g n I s s u e s o f R a n d o m i z e d P h a s e I I T r i a l s a n d a P r o p o s a l f o r P h a s e I I S c r e e n i n g T r i a l s . J C l i n O n c o l , 2 0 0 5 2 3 _ 7 1 9 9 - 7 2 0 6
[ 1 2 ] F D A . G u i d a n c e f o r C l i n i c a l T r i a l S p o n s o r s E s t a b l i s h m e n t a n d O p e r a t i o n o f C l i n i c a l T r i a l D a t a M o n i t o r i n g C o m m i t t e e s . 2 0 0 5 .
[ 1 3 ] E M E A . G u i d e l i n e o n D a t a M o n i t o r i n g C o m m i t t e e s . 2 0 0 6 .
[ 1 4 ] O k e n , M M , e t a l . T o x i c i t y a n d R e s p o n s e C r i t i e r i a o f t h e E a s t e r n C o o p e r a t i v e O n c o l o g y G r o u p . A m J C l i n O n c o l , 1 9 8 2 . 5 : 6 4 9 - 6 5 5 .
[ 1 5 ] H o l l e n P J , e t a l . M e a s u r e m e n t o f Q u a l i t y o f L i f e i n p a t i e n t s w i t h l u n g c a n c e r i n m u l t i c e n t e r t r i a l s o f n e w t h e r a p i e s . C a n c e r . 1 9 9 4 , 7 3 : 2 0 8 7 - 2 0 9 8 .
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