Prescribing Information Resources

30 Pages·2005·0.61 MB·English

3UHVFULELQJ,QIRUPDWLRQ5HVRXUFHV
8VHDQGSUHIHUHQFHE\JHQHUDO
SUDFWLWLRQHUV

$QH[SORUDWRU\VXUYH\RIJHQHUDO
SUDFWLWLRQHUV
7KH2YHUYLHZ
5HSRUWWRWKH0LQLVWU\RI+HDOWK
E\
7KH&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\
DQG
'HSDUWPHQWRI*HQHUDO3UDFWLFHDQG3ULPDU\+HDOWK&DUH
7KH8QLYHUVLW\RI$XFNODQG
'HFHPEHU
5HVHDUFK7HDP
%UXFH $UUROO)HOLFLW\ *RRG\ HDU6PLWK'HSDUWP HQWRI*HQHUDO3UDFWLFHDQG3ULP DU\+HDOWK
&DUH6FKRRORI3RSXODWLRQ+HDOWK)DFXOW\ RI0HGLFDODQG+HDOWK6FLHQFHV7KH8QLYHUVLW\ RI
$XFNODQG
'DQLHO3DWULFN&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\&+6536FKRRORI3RSXODWLRQ
+HDOWK)DFXOW\RI0HGLFDODQG+HDOWK6FLHQFHV7KH8QLYHUVLW\RI$XFNODQG
1JDLUH.HUVH'HSDUWP HQWRI*HQHUDO3UDFWLFH DQG3ULPDU\+HDOWK&DUH 6FKRRORI3RSXODWLRQ
+HDOWK)DFXOW\RI0HGLFDODQG+HDOWK6FLHQFHV7KH8QLYHUVLW\RI$XFNODQG
-HII+DUULVRQ6FKRRORI3KDUPDF\)DFXOW\RI0HGLFDODQG+HDOWK6FLHQFHV7KH8QLYHUVLW\ RI
$XFNODQG
-RDQ+DOOLZHOO'HSDUWPHQWRI*HQHUDO3UDFWLFH DQG3ULPDU\+HDOWK&DUH6FKRRORI3RSXODWLRQ
+HDOWK)DFXOW\RI0HGLFDODQG+HDOWK6FLHQFHV7KH8QLYHUVLW\RI$XFNODQG
-DQHW3HDUVRQ5R\/D\<HHDQG0DUWLQYRQ5D QGRZ&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG
3ROLF\&+6536FKRRORI3RSXODWLRQ+HDOWK) DFXOW\RI0HGLFDODQG +HDOWK6FLHQFHV7KH
8QLYHUVLW\ RI $XFNODQG DQG 'HSDUWPHQWRI6RFLRORJ\ )DFXOW\ RI$UWV7KH8QLYHUVLW\ RI
$XFNODQG
ZLWKWKHDVVLVWDQFHRI&DURO5DPDJH&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\&+653
6FKRRORI3RSXODWLRQ+HDOWK)DFXOW\ RI0HGLFDO DQG+HDOWK6FLHQFHV7KH8QLYHUVLW\ RI
$XFNODQG
DQGZLWKWKHVXSSRUWRI7KH6XUYH\5HVHDUFK8QLW658

,QTXLULHVFRQWDFW
&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\
7KH8QLYHUVLW\RI$XFNODQG
3ULYDWH%DJ
$XFNODQG
3K
(PDLOFKVUS#DXFNODQGDFQ]
&LWDWLRQ$UUROO%*RRG\HDU6PLWK)3DWULFN'.HUVH1+DUULVRQ-+DOOLZHOO-3HDUVRQ-
/D\<HH5YRQ5DQGRZ03UHVFULELQJ,QIRUPDWLRQ5HVRXUFHV8VHDQGSUHIHUHQFHE\
JHQHUDOSUDFWLWLRQHUV$QH[SORUDWRU\VXUYH\RIJHQHUDOSUDFWLWLRQHUV7KHRYHUYLHZ
5HSRUWWRWKH0LQLVWU\RI+HDOWK-XO\:HOOLQJWRQ0LQLVWU\RI+HDOWK
3XEOLVKHGLQ'HFHPEHUE\WKH0LQLVWU\RI+HDOWK32%R[:HOOLQJWRQ1HZ=HDODQG
,6%1:HE
+3
7KLVGRFXPHQWLVDYDLODEOHRQWKH0LQLVWU\RI+HDOWK¶VZHEVLWHKWWSZZZPRKJRYWQ]
'LVFODLPHU
7KHYLHZVH[SUHVVHGLQWKLVRFFDVLRQDOSDSHUDUH WKHSHUVRQDOYLHZVRIWKHDXWKRUVDQG VKRXOG
QRWEHWDNHQWRUHSUHVHQWWKHYLHZVRUSROLF\ RI WKH0LQLVWU\ RI+HDOWKRUWKH*RYHUQP HQW
$OWKRXJKDOOUHDVRQDEOHVWHSVKDYHEHHQWDNHQWR HQVXUHWKHDFFXUDF\ RI WKH LQIRUPDWLRQ QR
UHVSRQVLELOLW\LVDFFHSWHGIRUWKHUHOLDQFHE\ DQ\ SHUVRQRQDQ\ LQIRUPDWLRQFRQWDLQHGLQWKLV
RFFDVLRQDOSDSHUQRUIRUDQ\HUURULQRURPLVVLRQIURPWKHRFFDVLRQDOSDSHU

$FNQRZOHGJHPHQWV
7KHVWXG\WHDPZRXOGOLNHWRH[SUHVVWKHLUJUDWLWXGHWRWKHJHQHUDOSUDFWLWLRQHUVZKRWRRNSDUWLQ
WKLVVXUYH\ DQGDGGLWLRQDOO\ DSSUHFLDWLRQWRWK HLQWHUYLHZHUVIRUWKHLUZRUN DQG HIIRUWV WR
FRPSOHWHWKLVVXUYH\

7KH0LQLVWU\RI+HDOWKIXQGHGWKLVSURMHFW

:HDOVRWKDQNRXUUHYLHZHUVIRUWKHLUFRP PHQWV5REHUW3KLOOLSV'DYLG:RRGV-LP3ULPURVH
6WHSKHQ /XQJOH\ 5DFKHO0DFND\6KDURQ:RROODVWRQ5HVSRQVLELOLW\ IRUWKHILQDOSURGXFW
KRZHYHUUHVWVXOWLPDWHO\ZLWKWKHDXWKRUV
&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\
DQG'HSDUWPHQWRI*HQHUDO3UDFWLFHDQG3ULPDU\+HDOWK&DUH
7KH8QLYHUVLW\RI$XFNODQG
&RQWHQWV
5HVHDUFK7HDP LL
,QTXLULHVFRQWDFW LL
'LVFODLPHU LLL
$FNQRZOHGJHPHQWVLLL
,QWURGXFWLRQ
$LPVRIVWXG\
6XPPDU\RI/LWHUDWXUH5HYLHZ
,QIRUPDWLRQVRXUFHVIRU*3V
1HZGUXJDGRSWLRQE\*3V
)DFWRUVEH\RQGFOLQLFDOSUHVHQWDWLRQWKDWLQIOXHQFHSUHVFULELQJGHFLVLRQVE\
*3V
0HWKRGRORJ\
,QIRUPDWLRQFROOHFWLRQ±TXHVWLRQQDLUHGHVLJQ
'HVFULSWLRQRIWKH6DPSOH
5DQGRPQDWLRQDOVDPSOH
6HOIVHOHFWHG*3WUDLQHHVDPSOH
.H\)LQGLQJV
5HVRXUFHVXVHG
,QIOXHQFHVRQSUHVFULELQJ
$QDO\VLVRIIDFWRUVWKDWPLJKWLQIOXHQFHWKHXVHRIUHVRXUFHV
1HZWUDLQHH*3V
5HDVRQVIRUXVHQRQXVHRIUHVRXUFHV
5HVRXUFHV*3VZRXOGOLNHWRXVHRUDFFHVV
&RQFOXVLRQVDQG3ROLF\,PSOLFDWLRQV
5HIHUHQFHV

/LVWRI7DEOHV
7DEOH 3DUWLFLSDQWFKDUDFWHULVWLFV
7DEOH 3UDFWLFHFKDUDFWHULVWLFVRIVXUYH\UHVSRQGHQWV
7DEOH 3UDFWLFH0DQDJHPHQW6\VWHP306XVHG
7DEOH 'HJUHHRIFRPSXWHULVDWLRQ
7DEOH ,QWHUQHWDFFHVV
7DEOH 3DUWLFLSDQWFKDUDFWHULVWLFVIRUQHZWUDLQHHV
7DEOH 3UDFWLFHFKDUDFWHULVWLFVIRUQHZWUDLQHHV
7DEOH ,QWHUQHWDFFHVVIRUQHZWUDLQHHV
7DEOH )UHTXHQF\RIXVDJHRIVWDQGDUGSUHVFULELQJUHVRXUFHV
7DEOH 3HUFHLYHGXVHIXOQHVVRIVWDQGDUGSUHVFULELQJUHVRXUFHV
7DEOH 0RVWFRPPRQO\XVHGGDWDVRXUFHVZKHQVHHNLQJSUHVFULELQJLQIRUPDWLRQ
7DEOH 'LIIHUHQWVRXUFHWRWKDWPRVWFRPPRQO\XVHGZKHQVHHNLQJVSHFLILF
SUHVFULELQJLQIRUPDWLRQ
7DEOH )UHTXHQF\DQGXVHIXOQHVVRIFROOHDJXHVDQGRWKHUKHDOWKSURIHVVLRQDOVIRU
SUHVFULELQJ

3UHVFULELQJ,QIRUPDWLRQ5HVRXUFHV8VHDQGUHIHUHQFHE\JHQHUDOSUDFWLWLRQHUV LY
$QH[SORUDWRU\VXUYH\RIJHQHUDOSUDFWLWLRQHUV7KHRYHUYLHZ
&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\
DQG'HSDUWPHQWRI*HQHUDO3UDFWLFHDQG3ULPDU\+HDOWK&DUH
7KH8QLYHUVLW\RI$XFNODQG
,QWURGXFWLRQ
7KH0LQLVWU\RI+HDOWKWKH0LQLVWU\WKURXJKWKH1HZ=HDODQG0HGLFLQHVDQG0HGLFDO'HYLFHV
6DIHW\$XWKRULW\0HGVDIHDORQJZLWKRWKHUDJHQFLHVDQGERGLHVVXFKDVWKH0HGLFDO6FKRROV
WKH3KDUPDFHXWLFDO0DQDJHPHQW$JHQF\RI1HZ=HDODQG3+$50$&DQGWKH %HVW3UDFWLFH
Q]
$GYRFDF\&HQWUHESDF ±SURYLGHUVRIµEHVWSUDFWLFH¶LQIRUPDWLRQSURYLGHVUHVRXUFHVWKDWDLP
WRDVVLVWJHQHUDOSUDFWLWLRQHUV*3VWREHLQIR UPHGDERXWWKHP RVWDSSURSULDWHP HGLFLQHV WR
SUHVFULEHIRUSDWLHQWV7KHQDWXUHRILQIRUP DWLRQ UHVRXUFHVXVHGDQGWKRVHWKDWZRXOGEH
SUHIHUUHGKDVQRWWRGDWHEHHQHVWDEOLVKHG

7KH0LQLVWU\FRPPLVVLRQHGWKLVVWXG\7KHVWXG\SKDVHVLQFOXGHGVXUYH\GHVLJQTXHVWLRQQDLUH
GHYHORSPHQWSDUWLFLSDQWUHFUXLWPHQWGDWDFROOHFWLRQDQDO\VLVDQGGLVVHPLQDWLRQ

$SUHVFULELQJGHFLVLRQPD\KDYHVHYHUDOGLPHQVLRQV$WDEDVLFOHYHOVXFKDGHFLVLRQP D\EH
GHWHUPLQHGE\FKRRVLQJIURPDPRQJVWWKHGLIIHUHQWW\SHVRIPHGLFLQHVIXQGHGE\ 3+$50$&
RUFKRRVLQJWKRVHWKDWDWWUDFWWKH KLJKHVWVXEVLGLHV,QDZLGHUVHQVHDSUHVFULELQJGHFLVLRQLV
RQHWKDWD*3PDNHVEDVHGRQKLVRUKHUDVVHVVP HQWRIZKDWLVWKHUDSHXWLFDOO\ PRVWDSSURSULDWH
IRUWKHSDWLHQWDQGP D\LQFOXGHDZLGHUDQJH RILQSXWV7KH0LQLVWU\ VRXJKWNQRZOHGJHDERXW
SUHVFULELQJGHFLVLRQVDVXQGHUVWRRGLQWKHVHDQGRWKHUVHQVHV,WFRP PLVVLRQHGWKLV VWXG\ WR
H[SORUHWKHVRXUFHVWKDW*3VXVHWRLQIRUP WKHPVHOYHVRQSUHVFULELQJGHFLVLRQVRQFHWKH\ KDYH
OHIWPHGLFDOVFKRRODQGWKHUHODWHGEXWVHSDUDWHLVVXHRIKRZ *3VNHHSWKHLULQIRUPDWLRQXSWR
GDWH

7KH IDFWWKDWLQIRUP DWLRQLVDYDLODEOHGRHVQRW QHFHVVDULO\P HDQWKDWLWLVXVHGRUWKDWLWLV
DYDLODEOHLQDIRUP DWWKDW*3VZLVKWRXVH 7KH0LQLVWU\ VRXJKWWKHW\ SHVRILQIRUP DWLRQWR
LQIRUPSUHVFULELQJGHFLVLRQVWKDW*3V ZRXOG OLNHWRVHHP DGHDYDLODEOHDVZHOODVWKRVHWKDW
ZHUHFXUUHQWO\ DYDLODEOH)RUH[DP SOH*3V PD\SUHIHUWRVHHFKDQJHVWR WKH LQIRUPDWLRQ
FXUUHQWO\SURYLGHGE\ WKH0LQLVWU\ RURWKHUVRXUFHVLQWKHDUHDVRIGHOLYHU\ FRQWHQWIRUP DW
DQGRU UDQJH 3UHIHUHQFHV EHWZHHQSUHVHQWLQIRUP DWLRQVRXUFHVDQGDQ\ GHVLUHGVRXUFHVQRW
FXUUHQWO\DYDLODEOHDUHLPSRUWDQW

7KH0LQLVWU\ VRXJKWWKLVLQIRUP DWLRQWRKHOSLQVKDSLQJWKHGHYHORSP HQWRI SROLF\ WKH
SURYLVLRQRILQIRUPDWLRQWKDW*3VVHHNDQGLQDZLGHUVHQVHWKHLPSOHPHQWDWLRQRIWKH3ULPDU\
+HDOWK&DUH6WUDWHJ\:LWKWKHHVWDEOLVKPHQWRI3ULPDU\+HDOWK2UJDQLVDWLRQV3+2VDQGWKH

3HUIRUPDQFH)UDPHZRUNWREHLP SOHPHQWHGLQ WKHUHZLOOEHWKHSRVVLELOLW\ IRUIXUWKHU
GHYHORSPHQWRIFOLQLFDOJRYHUQDQFHFDSDELOLW\

7KLVUHSRUWLVWKH 2YHUYLHZDFRPSDQLRQWRWKHIXOOUHSRUW$UUROOHWDOZKLFKSURYLGHV
PDQ\PRUHGHVFULSWLYHWDEOHVDQGP RUH H[WHQVLYHGLVFXVVLRQDURXQGWKHOLWHUDWXUHUHYLHZDQG
WKHRXWFRPHVRIWKHVXUYH\

$LPVRIVWXG\
7KHVXUYH\KDGWKUHHNH\DLPV
7RHVWDEOLVKVRXUFHV*3VXVHWRLQIRUPWKHPVHOYHVRQSUHVFULELQJGHFLVLRQV
7RGHVFULEHKRZ*3VNHHSWKHLULQIRUPDWLRQXSWRGDWH
7RHVWDEOLVKZKDWRWKHUIDFWRUVLQIOXHQFH*3V¶SUHVFULELQJGHFLVLRQV

7KHVXUYH\DGGUHVVHGWKHIROORZLQJVL[UHVHDUFKTXHVWLRQV
:KDWW\SHVRILQIRUPDWLRQVRXUFHVGR*3VXVHDWSUHVHQW"
:KDWIDFWRUVLPSDFWRQWKH*3¶VGHFLVLRQWRXVHDSDUWLFXODUVRXUFH"

'UDIWRSHUDWLRQDOIUDPHZRUNIRU3+2SHUIRUPDQFHPDQDJHPHQW0LQLVWU\RI+HDOWK$SULO
3UHVFULELQJ,QIRUPDWLRQ5HVRXUFHV8VHDQGUHIHUHQFHE\JHQHUDOSUDFWLWLRQHUV
$QH[SORUDWRU\VXUYH\RIJHQHUDOSUDFWLWLRQHUV7KHRYHUYLHZ
&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\
DQG'HSDUWPHQWRI*HQHUDO3UDFWLFHDQG3ULPDU\+HDOWK&DUH
7KH8QLYHUVLW\RI$XFNODQG
:KDWVRXUFHVGR*3VXVHWRNHHSXSWRGDWHRQFKDQJHV"
:KDWLPSRUWDQFHGR*3VDWWULEXWHWRHDFKVRXUFH"
:KDWIXUWKHULQIRUPDWLRQPLJKW*3VOLNHWRDVVLVWWKHPWRPDNHGHFLVLRQVDERXWZKDWDQG
ZKHQWRSUHVFULEHPHGLFLQHVWRWKHLUSDWLHQWV"
:KDWVRXUFHVGR*3VYDOXHWKHPRVW"

3UHVFULELQJ,QIRUPDWLRQ5HVRXUFHV8VHDQGUHIHUHQFHE\JHQHUDOSUDFWLWLRQHUV
$QH[SORUDWRU\VXUYH\RIJHQHUDOSUDFWLWLRQHUV7KHRYHUYLHZ
&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\
DQG'HSDUWPHQWRI*HQHUDO3UDFWLFHDQG3ULPDU\+HDOWK&DUH
7KH8QLYHUVLW\RI$XFNODQG
6XPPDU\RI/LWHUDWXUH5HYLHZ
7KHOLWHUDWXUHUHYLHZH[DP LQHGVRXUFHVRILQIRUPDWLRQWKDW*3VXVHWRXSGDWHWKHLUNQRZOHGJH
WKHLUDGRSWLRQRIDQHZGUXJIRUDVSHFLILFWUHDWP HQWDQGIDFWRUVWKDWLQIOXHQFHWKHLUSUHVFULELQJ
SDWWHUQV0RVWRIWKHDFFHVVHGUHVHDUFKZDVLQ WHUQDWLRQDOEXW1HZ=HDODQGVWXGLHV ZHUH
UHIHUUHG WRZKHQDYDLODEOH7KHDFFXP XODWHGHYLGHQFHLQGLFDWHVWKDW*3 VIDFHDFRQVLGHUDEOH
FKDOOHQJHLQNHHSLQJXSWRGDWHZLWKWKHUDSLGO\LQFUHDVLQJNQRZOHGJHEDVHRIPHGLFLQH

,QIRUPDWLRQVRXUFHVIRU*3V
6RXUFHVXVHGE\GRFWRUVWRILQGP HGLFDONQRZOHGJHLQFOXGHWH[WERRNVMRXUQDOVDQGHOHFWURQLF
GDWDEDVHVEXWLWLVGLIILFXOWIRU*3VWRILQG XSWRGDWHLQIRUPDWLRQWRPDWFKLQGLYLGXDOSDWLHQWV
DQGWKH\PD\EHRYHUZKHOPHGE\WKHYROXPHRILQIRUPDWLRQSURYLGHG6P LWK&OLQLFDO
TXHVWLRQVZLWKLQIRUPDWLRQQHHGVUHJXODUO\ DULVHZKHQGRFWRUVVHHSDWLHQWV0DQ\ RIWKHVHDUH
DERXWGUXJVDQGDUHFRP SOH[DQGP XOWLGLPHQVLRQDO UHTXLULQJP RUHWKDQMXVWP HGLFDO
NQRZOHGJH±GRFWRUVDUHORRNLQJIRUJXLGDQFH VXSSRUWDIILUP DWLRQDQGIHHGEDFN 0RVW
TXHVWLRQV DULVLQJ GXULQJDFRQVXOWDWLRQDUHDQ VZHUHGDOWKRXJKP RVWO\QRWXVLQJHOHFWURQLF
VRXUFHV$UUROOHWDOLQDVXUYH\ RI1HZ=HDODQGIDPLO\SK\VLFLDQVFRQGXFWHGGXULQJWKH\ HDUV
±IRXQGRQO\ VL[RIDQVZHUHGTXHVWLRQVRXWRIDWRWDO TXHVWLRQVDVNHGE\
SDWLHQWVZHUHDQVZHUHGXVLQJDFRPSXWHULVHGVRXUFH$UUROOHWDO

,PSRUWDQWIHDWXUHVRILQIRUP DWLRQVRXUFHVDU H WKHLUFUHGLELOLW\ DYDLODELOLW\ VHDUFKDELOLW\
XQGHUVWDQGDELOLW\ DQGDSSOLFDELOLW\ &RQQHOO\ &RVWIDFWRUVVXFKDVWLP HDQGHQHUJ\
QHHGHGWRFRQGXFWDVHDUFKP D\EHYLHZHG DVP RUHLP SRUWDQWWKDQWKHTXDOLW\ RIWKH
LQIRUPDWLRQ0RVW*3VXVHDVPDOOUDQJHRILQIRUPDWLRQVRXUFHVWKDWDUHVXPPDULHVLQWKHIRUP
RIGHVNWRSVRXUFHV

*3VDUHP RVWOLNHO\ WRXVHGUXJUHIHUHQFHERRNVVXFKDVWKH 0HUFN0DQXDO DQG+DUULVRQ¶V
3ULQFLSOHVRI,QWHUQDO0HGLFLQHIRUSUHVFULELQJLQIRUPDWLRQ&RQQHOO\1HZ=HDODQG*3V
IUHTXHQWO\XVHWKH %ULWLVK1DWLRQDO)RUPXODU\ %1)RUWKH 0RQWKO\,QGH[RI0 HGLFDO
6SHFLDOWLHV0,060,061HZ(WKLFDOVWRFKHFNGRVHVDQGLQWHUDFWLRQVEXWZKLOHWH[WERRNV
DUHFRQVXOWHGPRVWIUHTXHQWO\WKH\DUHUDWHGDV OHVVYDOXDEOHWKDQFROOHDJXHV DQGVSHFLDOLVWVDV
LQIRUPDWLRQVRXUFHV&XOOHQ1RQSHHUUH YLHZHGSXEOLFDWLRQVDUHP RUH OLNHO\ WR
LQIOXHQFH*3SUHVFULELQJWKDQVFLHQWLILFSHHUUHYLHZHGMRXUQDOV

7KH,QWHUQHWRIIHUVKXJHSRWHQWLDOIRUGRFWRUV WRDFFHVVLQIRUPDWLRQEXWFDQEHWLPHFRQVXPLQJ
DQGWKHVKHHUDP RXQWRILQIRUP DWLRQFDQEHFRQIXVLQJ6WXGLHVLQGLFDWHWKDW *3V UHTXLUH
WUDLQLQJLQEDVLFLQIRUP DWLRQOLWHUDF\LGHQWLI\LQJHYLGHQFHEDVHGVRXUFHVDQG FULWLFDODSSUDLVDO
VNLOOV3RUWDOVWRJXLGH*3VWRVHOHFWHGUHVRXUFHVDQGDGRFXP HQWGHOLYHU\VHUYLFHZRXOGKHOS
*3VWRJHWXVHIXOLQIRUP DWLRQZLWKOLWWOHGHOD\ RUFRVW %\PRVW1HZ=HDODQGUXUDO*3V
KDGLQWHUQHWDFFHVVHLWKHUDWKRP HRUDWZRUN.HUVHEXWDVXUYH\ RIUXUDO *3V
IRXQGWKDWRQO\RQHWKLUGZHUHXVLQJWKH,QWHUQHW IRUKHOSZLWKSDWLHQWFDUHDW OHDVWRQFHDZHHN
-DQHV7KHVSHHGRILQWHUQHWDFFHVVRUWKHO DFNWKHUHRILVDOVRDYHU\ LPSRUWDQWIDFWRU
IRUHIIHFWLYHFOLQLFDOGHFLVLRQVXSSRUW±RIWHQP RUHVRWKDQWKHDFWXDOTXDOLW\ RIWKHLQIRUPDWLRQ
VRXUFH

&RPSXWHUEDVHGFOLQLFDOGHFLVLRQVXSSRUWV\VWHPVPD\LPSURYHFOLQLFLDQSHUIRUPDQFHDOWKRXJK
RXWFRPHVVXFKDVGUXJGRVHGHWHUP LQDWLRQKDYHQRW VKRZQFRQVLVWHQWLPSURYHPHQW+XQWHWDO
:KLOHHOHFWURQLFSURP SWVDQGDOHUWVP D\DVVLVWSUHVFULELQJ *3VPD\H[SHULHQFHµIODJ
IDWLJXH¶LIVXFKHOHFWURQLFSURP SWVDUHWRR IUHTXHQW RI OLWWOH FOLQLFDO VLJQLILFDQFH RU
LQDSSURSULDWHIRUSDUWLFXODUSDWLH QWV$KHDUQ*3VQHHGWREHWUDLQHGLQWKHXVHRIWKHVH
GHFLVLRQPDNLQJWRROVWREHDEOHWRXVHWKHPWRWKHLUIXOOH[WHQW

3UHVFULELQJ,QIRUPDWLRQ5HVRXUFHV8VHDQGUHIHUHQFHE\JHQHUDOSUDFWLWLRQHUV
$QH[SORUDWRU\VXUYH\RIJHQHUDOSUDFWLWLRQHUV7KHRYHUYLHZ
&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\
DQG'HSDUWPHQWRI*HQHUDO3UDFWLFHDQG3ULPDU\+HDOWK&DUH
7KH8QLYHUVLW\RI$XFNODQG
1HZGUXJDGRSWLRQE\*3V
,QWURGXFWLRQRIDQHZGUXJXVXDOO\ RFFXUVSURDF WLYHO\ E\PHDQVRIH[WHQVLYHDGYHUWLVLQJDQG
DFDGHPLF GHWDLOLQJ SURYLGHGE\ WKHSKDUP DFHXWLFDOLQGXVWU\ UDWKHUWKDQGLVVHP LQDWLRQRI
LQGHSHQGHQWVFLHQWLILFGDWD,QLWLDOXVHRIDGUXJLVRQDSHUVRQDOµWULDO¶EDVLVDQGIXWXUHXVHRID
GUXJLVVWURQJO\ LQIOXHQFHGE\ WKHLQLWLDOH[SHULHQFHRISUHVFULELQJ WKH GUXJ WR D SDUWLFXODU
SDWLHQWDVZHOODVLQIRUP DWLRQREWDLQHGIURPFUHGLEOHVRXUFHV3URVVHUHWDO -RQHV
$*3¶VRZQDVVHVVPHQWRIZKDWLQIOXHQFHVWKHLUSUHVFULELQJEHKDYLRXULV QRWDUHOLDEOHPHDVXUH
RIDFWXDOLQIOXHQFLQJIRUFHV$YRUQ

)DFWRUVEH\RQGFOLQLFDOSUHVHQWDWLRQWKDWLQIOXHQFHSUHVFULELQJGHFLVLRQVE\
*3V
7KHUHLVDWHQGHQF\ IRU*3VWREHUHDFWLYHU HFLSLHQWVUDWKHUWKDQDFWLYHVHDUFKHUVRI GUXJ
LQIRUPDWLRQ1HZ=HDODQG*3VP DLQO\XVHUHVRXU FHV WKDW WKH\KDYHDYDLODEOHWRWKHP DWWKH
RIILFH±WH[WERRNVDUHP RVWSUHIHUUHGWKHQFROO HDJXHVLQWKHLURZQSUDFWLFHDQG VSHFLDOLVWVRU
FRQVXOWDQWVDQGMRXUQDODUWLFOHV WKDWWKH\KDYHILOHGLQWKHRIILFH&XOOHQ7KH\ WHQGQRW
WRXVHP HGLFDOOLEUDULHVEHFDXVHRIDFFHVVSUREOHP V D ODFNRIVNLOOLQXVLQJFDWDORJXHVDQG
GDWDEDVHVDQGRUGLIILFXOW\ LQDSSO\ LQJUHVHDUFK OLWHUDWXUHWRFOLQLFDOVLWXDWLRQV,QWKLVVWXG\
*3VUDQNHGWKH,QWHUQHWKLJKHUWKDQPHGLFDOOLEUDULHVDVDVRXUFHRILQIRUPDWLRQ&XOOHQ

3KDUPDFHXWLFDOFRPSDQ\LQIRUPDWLRQHVSHFLDOO\WKDWSURYLGHGE\DYLVLWLQJUHSUHVHQWDWLYHPD\
EHDYHU\LPSRUWDQWSUHVFULELQJLQIOXHQFH3URVVHUDQG:DOOH\ *3VP D\QRWVHOIUHSRUW
WKLVDFFXUDWHO\ DQGGUXJFRP SDQ\ LQIRUPDWLRQ PD\LQIOXHQFHWKHP P RUHWKDQWKH\ UHDOLVH
0F*HWWLJDQ$YRUQ2IFRQFHUQ LVWKHIDFWWKDWPRVWGUXJDGYHUWLVLQJPDWHULDODQG
PDUNHWLQJEURFKXUHVFRQWDLQLQIRUPDWLRQZLWKQREDVLVLQVFLHQWLILFHYLGHQFH7XIIV

&RPPXQLW\SKDUPDFLVWVFDQLQIOXHQFHSUHVFULELQJE\ UHFRPPHQGLQJWRSUHVFULEHUVDWUHJXODU
\HWLQIUHTXHQWLQWHUYDOVWKDWWKH\ LQLWLDWHGLVF RQWLQXH RU FKDQJH GUXJWKHUDS\ ±*3VXVXDOO\
DFFHSWDQGLPSOHPHQWWKHLUVXJJHVWLRQV&DUUROO

*3VERWKLQ1HZ=HDODQGDQGRYHUVHDVDUHLQIOXHQ FHGE\KRVSLWDOSUHVFULELQJZLWKUHVSHFWHG
FROOHDJXHV EHLQJ LQIOXHQWLDODVSUHVFULELQJOHDG HUV&XOOHQ-RQHV3URVVHUHWDO
$GYLFHIURP DFROOHDJXHKDVEHHQUDWHGDVP RUHLP SRUWDQW WKDQ WKDW IURP ZULWWHQ
SKDUPDFHXWLFDO UHIHUHQFHV$YRUQ HW DODQGWKHP HGLXPLHYLDSHRSOHP D\EHP RUH
LPSRUWDQWWKDQWKHPHVVDJH0F*HWWLJDQ

1HZ=HDODQGLVRQHRIRQO\ WZR LQGXVWULDOLVHGFRXQWULHVWKDWSHUP LWGLUHFWWRFRQVXP HU
DGYHUWLVLQJ'7&$IRUSKDUPDFHXWLFDOV$VXUYH\ RI1HZ=HDODQG*3VIRXQGWKDWKDG
KDGFRQVXOWDWLRQVVSHFLILFDOO\ JHQHUDWHGE\ '7&$2QO\ EHOLHYHGWKDW '7&$ RI
SUHVFULSWLRQ GUXJV ZDV SRVLWLYH7RRSHWDO1HZ=HDODQG*3VKDYHSHWLWLRQHGWKH
0LQLVWHURI+HDOWKWREDQ'7&$.PLHWRZLF]

&KDQJHVLQIXQGLQJDUUDQJHP HQWVLQIOXHQFH*3SUHVFULELQJ 6WXGLHVRQSUHVFULELQJLQJHQHUDO
SUDFWLFHVLQWKH8QLWHG.LQJGRP EHIRUHDQGDI WHUWKH\EHFDPHIXQGKROGHUVIRXQGWKDWIXQG
KROGHUVKDGDORZHUUDWHRILQFUHDVHLQSUHVFULELQJFRVWV:LOVRQ ,Q 1HZ =HDODQG
3+$50$&XVHVUHIHUHQFHSULFLQJRISKDUP DFHXWLFDOVWRDFKLHYHDEDODQFHEHWZHHQ DFFHVV WR
SKDUPDFHXWLFDOVDQGFRVWFRQWDLQPHQW 3+$50$&GRHVWKLVE\ SD\LQJWKHVDP HVXEVLG\IRU
DOOGUXJVWKDWKDYHWKHVDPHRUVLPLODUFOLQLFDOWKHUDSHXWLFHIIHFWVIRUWUHDWLQJWKHVDPHRUVLPLODU
FRQGLWLRQV DFKLHYLQJ FRVW FRQWDLQPHQWE\ UHLPEXUVLQJGUXJVDWWKHORZHVWSULFHUXOLQJIRUD
WKHUDSHXWLFVXEJURXS

3UHVFULELQJ,QIRUPDWLRQ5HVRXUFHV8VHDQGUHIHUHQFHE\JHQHUDOSUDFWLWLRQHUV
$QH[SORUDWRU\VXUYH\RIJHQHUDOSUDFWLWLRQHUV7KHRYHUYLHZ
&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\
DQG'HSDUWPHQWRI*HQHUDO3UDFWLFHDQG3ULPDU\+HDOWK&DUH
7KH8QLYHUVLW\RI$XFNODQG
$FDGHPLFGHWDLOLQJYLVLWVDUHHIIHFWLYHLQLQIO XHQFLQJSUHVFULELQJEHKDYLRXUZKHWKHUSHUIRUPHG
DORQHRULQFRP ELQDWLRQZLWKRWKHULQWHUY HQWLRQV7KRP VRQ2¶%ULHQ$XGLWV DQG
IHHGEDFNWRKHDOWKFDUHSURIHVVLRQDOVDOVRKDYH WKHSRWHQWLDOWR FKDQJHSUHVFULELQJEHKDYLRXU
-DPWYHGWEXWP HUHO\SRVWLQJ DJJUHJDWHG IHHGEDFNGDWDLVXQOLNHO\ WRHIIHFWEHKDYLRXU
FKDQJH2¶&RQQHOO

$VLQJOHFRQWLQXLQJP HGLFDOHGXFDWLRQ&0(VHVVLRQLVXQOLNHO\ WRFKDQJHEHKDYLRXUUDWKHU
FKDQJHLVHYROXWLRQDU\ LQUHVSRQVHWR DFTXLULQJQHZNQRZOHGJHIURP DYDULHW\ RIGLIIHUHQW
FUHGLEOHVRXUFHV*RRG\ HDU6PLWK(IIHF WLYHVWUDWHJLHVLQFOXGH UHPLQGHUV SDWLHQW
PHGLDWHGLQWHUYHQWLRQVRXWUHDFKYLVLWVRSLQLRQOHDGHUVDQGPXOWLIDFHWHGDFWLYLWLHV'DYLV
&0(PHHWLQJVZLWKLQ WKH1HZ=HDODQGVHWWLQJP D\JLYH*3VDFFHVVWRVSHFLDOLVWNQRZOHGJH
ZKLFKKDVDVLJQLILFDQWLQIOXHQFHRQ*3V¶SUDFWLFH&XOOHQ

3UHVFULELQJ,QIRUPDWLRQ5HVRXUFHV8VHDQGUHIHUHQFHE\JHQHUDOSUDFWLWLRQHUV
$QH[SORUDWRU\VXUYH\RIJHQHUDOSUDFWLWLRQHUV7KHRYHUYLHZ
&HQWUHIRU+HDOWK6HUYLFHV5HVHDUFKDQG3ROLF\
DQG'HSDUWPHQWRI*HQHUDO3UDFWLFHDQG3ULPDU\+HDOWK&DUH
7KH8QLYHUVLW\RI$XFNODQG
0HWKRGRORJ\
,QIRUPDWLRQFROOHFWLRQ±TXHVWLRQQDLUHGHVLJQ
$UHYLHZRIQDWLRQDODQGLQWHUQDWLRQDOOLWHUDWX UHZDVFRQGXFWHGWRDVFHUWDLQNH\ LQGLFDWRUV
PHDVXUHV DQG TXHVWLRQVIRUWKHVWXG\ 7KLVHQ VXUHGWKDWWKHGDWDFROOHFWLRQZRXOGDQVZHU
UHOHYDQWUHVHDUFKTXHVWLRQVDQGHQVXUHFRP SDUDELOLW\ZLWKVLP LODULQWHUQDWLRQDOUHVHDUFK ,Q
DGGLWLRQFRQVXOWDWLRQZLWKNH\ VWDNHKROGHU UHSUHVHQWDWLYHVZDVXQGHUWDNHQ7KH0LQLVWU\
UHYLHZHGDQGFRP PHQWHGRQWKHVWXG\ TXHVWLRQQD LUH3RWHQWLDOVRXUFHVRILQIRUP DWLRQIRU
SUHVFULELQJDQGIDFWRUVDQGVRXUFHVRILQIRUP DWLRQWKDW PLJKW KDYH LQIOXHQFHG SUHVFULELQJ
EHKDYLRXUZHUHDVFHUWDLQHGIURP SUHYLRXVVWXGL HV$GGLWLRQDOO\ SRWHQWLDOVRXUFHV XQLTXH WR
1HZ=HDODQGRUXQGHUUHVHDUFKHGLQSUHYLRXVDSSURDFKHVZHUHDGGHG

'DWDFROOHFWLRQZDVFDUULHGRXWXVLQJ&RP SXWHU $VVLVWHG7HOHSKRQH,QWHUYLHZLQJ&$7,
SURYLGLQJDQLQWHUYLHZHUZLWKTXHVWLRQVHOHFWURQL FDOO\RQVFUHHQZLWKUHVSRQVHVHQWHUHG GLUHFWO\
LQWRDGDWDEDVHGXULQJLQWHUYLHZV,QWHUYLHZV DYHUDJHGPLQXWHVLQOHQJWKDQGFRYHUHGWRSLFV
VSHFLILFWRWKHXVHRISUHVFULELQJ LQIRUPDWLRQVRXUFHVIDFWRUVLQIOXHQFLQJSUHVFULELQJ
GHPRJUDSKLFVDQGVHOHFWHGFOLQLFDOFDVHV&$7,XVHVVSHFLILFVRIWZDUHWRPDQDJHVXUYH\V±WKLV
VWXG\ZDVPDQDJHGXVLQJ6XUYH\ 6\VWHPVYHUVLRQE\ &UHDWLYH5HVHDUFK6\ VWHPV$SLORW
&$7,VXUYH\ ZLWKDVXEVDP SOHRI*3V1 ZLWK GLIIHULQJ FKDUDFWHULVWLFV DQG
EDFNJURXQGVZDVFRQGXFWHGWRWHVWIRUFRPSUHKHQVLRQDQGTXHVWLRQQDLUHVWUXFWXUHDQGWRDOORZ
IRUHUURUWUDSSLQJZLWKLQWKH&$7,VRIWZDUH

$VDUHVXOWRIWKHSLORWLQWHUYLHZVWKHTXHVWLRQQD LUHZDVUHILQHG7KHVHSLORWLQWHUYLHZVDUHQRW
LQFOXGHG LQ WKHUHVXOWVSUHVHQWHGZLWKLQWKLVUH SRUW,QDGGLWLRQWKHSLORWVXUYH\ SURFHVV
JXDUDQWHHGWKDWWKHLQVWUXPHQWZDVDEOHWRPHHWWKHDLPVVHWRXWIRUWKLVSURMHFWDQGHQVXUHGWKDW
WKHTXHVWLRQQDLUHZDVZHOOVWUXFWXUHGDQGZRXOGEHHDVLO\FRPSUHKHQGHGE\VWXG\SDUWLFLSDQWV

7KHILQDOTXHVWLRQQDLUHLVDYDLODEOHRQUHTXHVW

6DPSOLQJ
7KHVXUYH\FRPSULVHGWZRVDPSOLQJIUDPHVDVRXWOLQHGEHORZ

0DLQVXUYH\
$ UDQGRPQDWLRQDOO\ UHSUHVHQWDWLYHVDP SOHRI1HZ=HDODQG*3FRQWDFWVLQFOXGLQJ
WHOHSKRQHDQGID[QXPEHUVZDVSXUFKDVHGIURP 0HGL0HGLD1=/WGQRZ&030HGLFD1=
/WG2QO\ RIWKH*3VLQWKLVVDP SOHZHUH UHTXLUHGWREHFRQWDFWHGWRDFKLHYHWKHGHVLUHG
VDPSOHVL]H7KLVVWXG\DVFHUWDLQVYDULRXVSHUFHQWDJHVRILQWHUHVWDQGIRUDVDP SOHVL]HRI

WKHVWDQGDUGHUURURIVXFKSHUFHQWDJHVZRXOGEHOHVVWKDQ î 7KHP DUJLQRI

HUURUDSSUR[LP DWHO\WZLFHWKHVWDQGDUG HUURUFRQILGHQFHLQWHUYDOZRXOGEHOHVVWKDQ
7KHHYHQWXDOVDP SOHVL]HRIWKHP DLQVX UYH\ZDV*3VGXHWRFRQWDFWHG *3VEHLQJ
LQHOLJLEOHWRSDUWDNHUHIXVLQJRU QRW FRPSOHWLQJWKHLQWHUYLHZVHHWKHIXOOUHSRUWIRUP RUH
GHWDLOV$UUROOHWDO $QLQFRPSOHWHLQWHUYLHZRFFXUUHGZKHQD*3ZDVXQDEOHWRILQLVK
DQLQWHUYLHZGXHWRXQIRUHVHHQFLUFXPVWDQFHV

&RQWDFW'DQLHO3DWULFNHPDLOGSDWULFN#DXFNODQGDFQ]
3UHVFULELQJ,QIRUPDWLRQ5HVRXUFHV8VHDQGUHIHUHQFHE\JHQHUDOSUDFWLWLRQHUV
$QH[SORUDWRU\VXUYH\RIJHQHUDOSUDFWLWLRQHUV7KHRYHUYLHZ