strategic clinical study design

8/2/2019 Strategic Clinical Study Design

http://slidepdf.com/reader/full/strategic-clinical-study-design 1/14

Q}ph}bfla Aclolahc Q}rm| Mbqlfo

H Zpgzgqbm Mbubcgzkbo} Zcho egp Mbclubplof

h Ogubc Zbz}lmb Ho}l`lg}la }g Khpib}

Q}ph}bfla Aclolahc Q}rm| MbqlfoH Zpgzgqbm Mbubcgzkbo} Zcho egp Mbclubplof


KZ]^ 288Eb`prhp| 05}n# 0:80

Gplo Anh}}gzhmn|h|Clqh FrckgoFbgeepb| Ngrfn}goFhrphu Kgchoihp

8






H`q}pha}]nb hmubo} ge krc}l+mprf pbqlq}ho} `ha}bplhc zh}ngfboq nhq pbqrc}bm lo h phzlm loapbhqb lo ngqzl}hc+

hqqgalh}bm loeba}lgoq lo lkkrogagkzpgklqbm zh}lbo}q/ Ebv agkzholbq gz} }g mbubcgz ho}l`lg}laq mrb }g}nb b}nlahc hom pbfrch}gp| lqqrbq qrppgromlof ho}l`lg}la aclolahc }plhcq/ Mbqzl}b }nb mleelarc}lbq agkzholbq

ehab lo agomra}lof aclolahc }plhcq egp ho}l`lg}laq# looguh}lub mprfq hpb obbmbm }g kbmlh}b }nlq fcg`hc aplqlq/

]nlq pbzgp} zpgzgqbq qgcr}lgoq }g }nbqb lqqrbq `| mbubcgzlof h aclolahc }plhc zpgfphk egp h ogubc

cbriga|}b zbz}lmb ho}l`lg}la/ Hzzpgzplh}b pbfrch}gp| q}ph}bf|# }hpfb} zgzrch}lgo# }plhc mbqlfo# hom agq}

hohc|qlq hpb gr}clobm lo gpmbp }g q}ph}bflahcc| zgql}lgo }nlq zpgmra}/

Lo}pgmra}lgo]nb lohzzpgzplh}b rqb ge ho}l`lg}laq lo nrkhoq hom holkhcq nhq zpgmrabm pbqbpuglpq ge pbqlq}ho} `ha}bplh

hom kg`lcb pbqlq}hoab fbobq/ Qloab }nb hmubo} ge ho}l`lg}laq obhpc| 6: |bhpq hfg# fcg`hc }phmb hom }phubc

nhq zpgkg}bm }nb qzpbhm ge pbqlq}ho} `ha}bplh/ Bubo Uhoagk|alo# goab }nb –ho}l`lg}la ge chq} pbqgp}#‛ nhq

`bbo pbombpbm rqbcbqq `| Uhoagk|alo+pbqlq}ho} Bo}bpgagaal .UPB,/ UPB vl}n }nb Uhoagk|alo

pbqlq}hoab fbob# uhoH# elpq} bkbpfbm lo Brpgzb lo 8<>6/ @| }nb 8<<:q# gubp 02" ge Bo}bpgagaal

pbqzgoql`cb egp `cggmq}pbhk loeba}lgoq lo }nb R/Q/ zgqqbqqbm }nb uhoH fbob/8 Qloab }nbo# }nb uhoH fbob

nhq `bbo haxrlpbm `| hmml}lgohc `ha}bplhc zh}ngfboq/

Loeba}lgoq ahrqbm `| }nbqb krc}l+mprf pbqlq}ho} zh}ngfboq pbqrc} lo b~}bombm ngqzl}hc q}h|q# loapbhqbm

nbhc}nahpb agq}q# hom nlfnbp kgp}hcl}| ph}bq/ ]nb bkbpfboab ge fcg`hc `ha}bplhc pbqlq}hoab agkzpgklqbq

}nb `bobel}q ge khdgp nbhc}nahpb hmuhoabq/ Lo}bpubo}lgoq qran hq qrpfbp|# }phoqzcho}h}lgo# NLU

}pbh}kbo}q hom anbkg}nbphz| hpb agkzclah}bm `| mleelarc}+}g+}pbh} `ha}bplhc loeba}lgoq/0

Pbqlq}hoab nhq egpabm mga}gpq }g egpfg beeba}lub mprfq egp cbqq mbqlph`cb# gcmbp ho}l`lg}laq/ ]nlq lq og} holmbhc qgcr}lgo `bahrqb }nbqb mprfq hpb rohuhlch`cb lo kho| zhp}q ge }nb vgpcm/ H q}rm| buhcrh}lof }nb

ulh`lcl}| ge rqlof gcmbp ho}l`lg}laq }g }pbh} pbqlq}ho} `ha}bplh egrom }nh} goc| 88 ge }nb 11 ho}l`lg}laq

qbcba}bm `| ho lo}bpoh}lgohc zhobc ge b~zbp}q egp rqb go pbqlq}ho} `ha}bplh vbpb huhlch`cb lo h} cbhq} nhce ge

}nb 1> agro}plbq qrpub|bm/1 Lo hmml}lgo }g `blof vlmbc| lohaabqql`cb# }nbqb mprfq hpb ge}bo kgpb }g~la hom

b~zboqlub }nho kgmbpo ho}l`lg}laq/

Mbqzl}b }nbqb hchpklof q}h}lq}laq# ebv agkzholbq hpb zrpqrlof }nb mbubcgzkbo} ge ogubc ho}l`lg}laq/=

]nb kg`lcl}| ge ho}l`lg}la pbqlq}hoab fbobq hom }nb agkzcb~ }pbh}kbo}q pbxrlpbm }g }pbh} pbqlq}ho}

`ha}bplhc loeba}lgoq khib h ago}pgccbm ho}l`lg}la }plhc mleelarc} }g haagkzclqn/ Lo }nlq pbzgp}# vb vlcc

b~hklob zg}bo}lhc qgcr}lgoq }g }nbqb lqqrbq `| mbqlfolof h aclolahc }plhc zpgfphk egp h ogubc cbriga|}b

zbz}lmb ho}l`lg}la/

B~}boqlub zpbzhph}lgo krq} qrzzgp} }nb mbubcgzkbo} hom b~bar}lgo ge aclolahc }plhcq/ ]nb aclolahc

mbubcgzkbo} zcho krq} agoqlmbp }nb egpkrch}lgo anhpha}bplq}laq ge }nb kgcbarcb hom obbmq }g zpgulmb h

ebhql`cb khoreha}rplof zcho/ Bzlmbklgcgfla zh}}bpoq# bqzbalhcc| lo }nb ago}b~} ge ho}l`lg}la }plhcq# qngrcm

`b agoqlmbpbm/ Kgpbgubp# h agkzho| aho goc| kgub egpvhpm vl}n aclolahc }plhcq go }nb `hqlq ge h qgclm

agkkbpalhc ph}lgohcb egp aclolahc mbubcgzkbo}/ H agkzho| krq} hqqbqq rokb} aclolahc hom khpib} obbmq

hom egpkrch}b khpib} zpgdba}lgoq/ Bq}h`clqnlof ho lo}bpoh}lgohc q}ph}bf| hom kgol}gplof }nb zpgfpbqq ge

qlklchp }plhcq hpb hcqg lo}bfphc }g h qraabqqerc aclolahc zpgfphk/

0






H ercc aclolahc }plhc zpgfphk loacrmbq znhqbq L# LL# LLL# hom zgq}+khpib}lof }plhcq/ ]npgrfngr} }nb zchoolof

q}hfbq# khpib}lof hom agpzgph}b vlcc boqrpb }nh} }nb agkzho|“q aclolahc q}ph}bf| egp bhan zgp}lgo ge }nb

zpgfphk haarph}bc| hclfoq vl}n agpzgph}b fghcq/ Bhan znhqb ge }nb aclolahc zpgfphk krq} nhub h vbcc+

mbelobm }hpfb} zgzrch}lgo# zpg}gagc g`dba}lubq# }plhc mbqlfo# qhkzcb qltb# hom }lkbclob/ Mbqlfoh}lof ib|

mbalqlgo zglo}q hom ago}lofboa| zchoq egp bhan q}hfb lq hcqg apl}lahc/ ]nb P%M# pbfrch}gp|# hom

gzbph}lgoq mlulqlgoq ge h agkzho| krq} agcch`gph}b }g ho}lalzh}b hom ercelcc }nb elohoalhc# zbpqgoobc# hom

ehalcl}lbq pbxrlpbkbo}q }g pro h }plhc/ Egp kho| qkhcc agkzholbq# haabqqlof }nbqb pbqgrpabq kh| lougcub

zhp}obplof vl}n h chpfbp agkzho| gp ago}pha}lof gr} vgpi }g }nlpm zhp}| ubomgpq/

Pbfrch}gp| Q}ph}bf|H zpgha}lub hzzpghan }g pbfrch}gp| heehlpq vlcc `b lo}bfphc }g agkzb}l}lubc| zgql}lgolof }nlq zpgmra}/ Hq

h ogubc ho}l`lg}la }nh} hmmpbqqbq cleb+}npbh}bolof loeba}lgoq# grp zpgmra} vlcc clibc| `b bclfl`cb egp }nb

EMH“q Ehq} ]phai mbqlfoh}lgo/ Ehq} ]phai q}h}rq vgrcm hccgv grp agkzho| }g kbb} hom agppbqzgom

kgpb epbxrbo}c| vl}n }nb EMH pbfhpmlof aclolahc }plhc mbqlfo hom }nb }|zbq ge mh}h pbxrlpbm }g qrzzgp}

hzzpguhc/ Mprfq }nh} nhub pbablubm Ehq} ]phai mbqlfoh}lgo hpb }|zlahcc| fpho}bm h Zplgpl}| Pbulbv homhpb ge}bo bclfl`cb egp Haabcbph}bm Hzzpguhc `hqbm go qrppgfh}b bomzglo}q gp pbq}pla}bm mlq}pl`r}lgo/

Haabcbph}bm Hzzpguhc vgrcm hccgv rq }g agcchzqb grp aclolahc }plhc zhphmlfk hom }g khpib} grp zpgmra}

qggobp/ Grp zpgmra} kh| hcqg xrhcle| egp }nb EMH“q Pgcclof Pbulbv zpgabqq/ Pgcclof Pbulbv hccgvq h

agkzho| }g qr`kl} mh}h egp pbulbv hq l} lq g`}hlobm# ph}nbp }nho vhl}lof ro}lc }nb agkzcb}lgo ge hcc

aclolahc }plhcq }g qr`kl} h qr`klqqlgo zhaib}/ B~zcgplof }nbqb gz}lgoq hom pbxrbq}lof Ehq} ]phai q}h}rq

bhpc| lo }nb aclolahc mbubcgzkbo} znhqb vgrcm boh`cb rq }g }hib ercc hmuho}hfb ge }nbqb `bobel}q mrplof

aclolahc }plhcq/2

Grp agkzho| krq} bo}bp }nb LOM hzzpguhc zpgabqq vl}n h vbcc+pbqbhpanbm zpg}gagc hom h ahpbercc|

qbcba}bm }hpfb} zgzrch}lgo/ Vnbo agoqlmbplof qzbalela `ha}bplhc zh}ngfboq }g hmmpbqq lo grp }hpfb}

zgzrch}lgo# vb agoqlmbpbm }nb qzbalbq qbcba}bm `| Khannh b} hc/ lo }nblp q}rm| ge Hkbplaho hcclfh}gpcbriga|}b b~}pha} }g `b qrl}h`cb ahomlmh}bq/5 @bahrqb grp cbriga|}b zpgmra} lq kgpb zg}bo} }nho }nb

Hkbplaho hcclfh}gp b~}pha}q rqbm lo }nb q}rm|# vb b~zba} }g mbkgoq}ph}b h qlfolelaho} }nbphzbr}la heeba}

go loeba}lgoq ahrqbm `| }nbqb `ha}bplhc qzbalbq/

@ha}bplhc Zh}ngfboq hom ]hpfb} Zgzrch}lgo]nb zh}ngfboq rqbm `| Khannh b} hc/# Zqbrmgkgohq hbprflogqh# Bo}bpgagaarq ehbalrk# hom Icb`qlbcch

zobrkgolhb# hpb hzzpgzplh}b }hpfb}q `bahrqb }nb| hpb pbqzgoql`cb egp h qlfolelaho} zpgzgp}lgo ge hcc

ngqzl}hc+hqqgalh}bm# gp ogqgagklhc# loeba}lgoq/5 Vnlcb zh}lbo} loacrqlgo vlcc og} `b `hqbm go }nb

zh}ngfbo ahrqlof }nb zh}lbo}“q loeba}lgo# qbcba}lof zh}lbo}q vl}n loeba}lgoq agkkgoc| hqqgalh}bm vl}n

}nbqb qzbalbq vlcc boh`cb rq }g mbkgoq}ph}b grp mprf“q beelaha| hfhloq} }nbqb zh}ngfboq/ Hohc|tlof }nb}|zbq ge loeba}lgoq zpgmrabm `| zh}ngfboq }nh} grp mprf nhq lonl`l}bm lo bhpclbp q}rmlbq aho nbcz rq }g

ahcl`ph}b grp b~zba}bm lomlah}lgoq egp }nb mprf/ ]nrq# vb aho khib ho bmrah}bm qbcba}lgo ge grp }hpfb}

zgzrch}lgo/

Zqbrmgkgohq hbprflogqh lq h fphk+obfh}lub `ha}bplrk epbxrbo}c| hqqgalh}bm vl}n gzzgp}rolq}la

loeba}lgoq lo ngqzl}hcltbm zh}lbo}q/ ]nbqb loeba}lgoq kh| heeba} h uhplb}| ge }lqqrbq hom gpfhoq lo

lkkrogagkzpgklqbm lomlulmrhcq/ Egp b~hkzcb# Z/ hbprflogqh kh| zpgmrab zobrkgolh lo zh}lbo}q

rqlof ubo}lch}gpq# rplohp| }pha} loeba}lgoq lo zh}lbo}q rqlof rplohp| ah}nb}bpq# gp `ha}bpbklh lo ahoabp

zh}lbo}q/ @rpo loeba}lgoq hom pbqzlph}gp| loeba}lgoq lo a|q}la el`pgqlq zh}lbo}q hpb hcqg agkkgo/ ]nlq

1






qzbalbq aho mbubcgz ho}l`lg}la pbqlq}hoab xrlaic| vnbo goc| gob kr}h}lgo lq pbxrlpbm }g agoebp

pbqlq}hoab/ Agoqbxrbo}c|# qgkb q}phloq hpb pbqlq}ho} }g kgq} ho}l̀ lg}laq/ ]nb beelaha| ge b~lq}lof

ho}l`lg}la achqqbq mbzbomq go cgah}lgo ge }nb loeba}lgo9 vnlcb hklogfc|agqlmbq mg og} hmmpbqq crof

loeba}lgoq vbcc# g}nbp achqqbq }pbh} }nbqb loeba}lgoq qraabqqercc|/6 ]g hohc|tb }nb zbpegpkhoab ge grp mprf

lo mleebpbo} }lqqrbq# vb vlcc qbcba} qbubphc }|zbq ge `ha}bplhc loeba}lgoq }g loacrmb lo grp aclolahc }plhcq/

]nb fphk+obfh}lub `ha}bplrk# Icb`qlbcch zobrkgolhb# ahrqbq `cggm loeba}lgoq# zobrkgolh# hom

kbolofl}lq lo lkkrogagkzpgklqbm zh}lbo}q/ ]nb eha} }nh} }nbqb `ha}bplh ogpkhcc| lonh`l} }nb nrkho

fhq}pglo}bq}lohc }pha} khibq }nbk h epbxrbo} qgrpab ge loeba}lgoq lo ngqzl}hcltbm zh}lbo}q/ Kbmlahc

mbulabq qran hq ubo}lch}gpq hom ah}nb}bpq hpb agkkgo bo}p| zglo}q egp }nb `ha}bplh/ ]nlq `ha}bplh“q

pbqlq}hoab }g ahp`hzbobk ho}l`lg}laq khibq loeba}lgoq zhp}larchpc| mleelarc} }g }pbh}/>

Bo}bpgagaarq ehbalrk lq h fphk+zgql}lub `ha}bplrk ogpkhcc| egrom lo }nb nrkho mlfbq}lub }pha}/

Qlklchp }g Z/ hbprflogqh hom I/ zobrkgolhb# }nlq `ha}bplrk lq pbqzgoql`cb egp h`mgklohc# qilo# rplohp|

}pha}# hom `cggm loeba}lgoq/ Hcc }npbb `ha}bplh hpb epbxrbo} hom qbplgrq ogqgagklhc# gp ngqzl}hc+haxrlpbm#zh}ngfboq/ B/ ehbalrk nhq mbkgoq}ph}bm pbqlq}hoab }g krc}lzcb ho}l`lg}la achqqbq loacrmlof xrlogcgobq

hom hklogfc|agqlmbq/ H q}rm| epgk }nb ch}b 8<<:q hohc|tbm 82#::: Bo}bpgagaarq lqgch}bq hom

mlqagubpbm }nh} 20" ge }nb B/ ehbalrk lqgch}bq vbpb pbqlq}ho} }g Uhoagk|alo# }nb –ho}l`lg}la ge chq}

pbqgp}#‛ hom >1" vbpb Hkzlalcclo+pbqlq}ho}/< ]nbqb pbqlq}hoab ph}bq ago}lorb }g aclk` lo }nb RQ# Brpgzb#

Hqlh# hom Qgr}n Hkbplah# apbh}lof h qbplgrq nbhc}n aplqlq }nh} vgrcm `bobel} epgk h ogubc ho}l`lg}la/

Vnlcb }nb bzlmbklgcgf| ge B/ ehbalrk uhplbq epgk agro}p| }g agro}p|# }nb khdgpl}| ge Uhoagk|alo+

pbqlq}ho} q}phloq agccba}bm epgk ngqzl}hcq hpb }nb qhkb acgohc clobhfb# khilof l} ho b~abccbo} zh}ngfbo

egp g`}hlolof agkzhph`cb pbqrc}q lo lo}bpoh}lgohc }plhcq/8 ]nlq qzbalbq lq hcqg lkzgp}ho} }g }hpfb} lo grp

aclolahc }plhcq `bahrqb l} boh`cbq rq }g fhrfb grp zpgmra}“q beelaha| hfhloq} fphk+zgql}lub `ha}bplh/

Elfrpb 8/ 0::< ph}bq ge Uhoagk|alo+pbqlq}hoab hkgof B/ ehbalrk lqgch}bq lo Brpgzb/8:

Grp cbriga|}b mprf“q ho}l`lg}la ha}lul}| hfhloq} Kb}nlalcclo+pbqlq}ho} Q}hzn|cgagaarq hrpbrq .KPQH,

=






vlcc hcqg `b ge lo}bpbq}/ ]ngrfn og} q}rmlbm `| Khannh b} hc/# KPQH lq ge zhp}larchp lo}bpbq} `bahrqb ge

l}q h`lcl}| }g phzlmc| mbubcgz pbqlq}hoab }g kgq} agkkgoc| rqbm ho}l`lg}laq/88 Lo eha}# Q/ hrpbrq haxrlpbm

}nb Uhoagk|alo+pbqlq}hoab fbob# uhoH# epgk Uhoagk|alo+pbqlq}ho} Bo}bpgagaal/80 ]nbqb pbqlq}hoab

zh}}bpoq mbkgoq}ph}b }nb qbplgrq hom ge}bo ro}pbh}h`cb oh}rpb ge KPQH loeba}lgoq/

Elfrpb 0/ ]nlq lccrq}ph}lgo mbzla}q }nb zpbuhcboab ge Kb}nlalcclo+pbqlq}ho} Q/ hrpbrq lo Ch}lo Hkbplah hom }nb

Ahpl``bho/0

Grp mlqagubp| ge h ogubc ho}l`ha}bplhc zpgmra} lqgch}bm epgk }nb Anlobqb Hcclfh}gp zpbqbo}q ho b~abccbo}

ahomlmh}b egp zh}lbo}q qreebplof epgk ho}l`lg}la+pbqlq}ho} `ha}bplhc loeba}lgoq/ Grp znhqb LL hom LLL }plhcq

vlcc }hpfb} lkkrogagkzpgklqbm zh}lbo}q qreebplof epgk loeba}lgoq ahrqbm `| }nb `ha}bplh mbqapl`bm

h`gub/ Zh}lbo}q vl}n loeba}lgoq hqqgalh}bm vl}n anbkg}nbphz|# qrpflahc ql}b vgromq# qbubpb `rpoq# gp

pbqzlph}gp| agoml}lgoq hpb lmbhc ahomlmh}bq egp grp }hpfb} zgzrch}lgo/

2






Elfrpb 1/ Zh}lbo}q vl}n }nb h`gub agoml}lgoq hpb zpbmlqzgqbm }g mbubcgzlof ho}lklapg`lhc+pbqlq}ho} loeba}lgoq/=

Znhqb L hom LL ]plhcq]nb elpq} q}bz }gvhpm mbkgoq}ph}lof ho}l`ha}bplhc zpgzbp}lbq lo nrkhoq lq agomra}lof znhqb L }plhcq/ Egp

grp znhqb L }plhc# vb vlcc pbaprl} 1:+2: nbhc}n| qr`dba}q }g bq}h`clqn }nb kh~lkrk }gcbph`cb mgqb ge grp

zpgmra}/ Egp znhqb LL }plhc mbqlfo# vb cggi }g h agkzcb}bm aclolahc }plhc egp }nb ho}l`lg}la Mgplzbobk egp

frlmhoab/ Lo }nlq znhqb LL }plhc# Mgplzbobk# ho lodba}h`cb ahp`hzbobk ho}l`lg}la vhq hmklolq}bpbm }g

zh}lbo}q vl}n ogqgagklhc hom ubo}lch}gp+hqqgalh}bm zobrkgolh ahrqbm `| `ha}bplh qran hq Z/ hbprflogqh/

]nb q}rm| bopgccbm 8>2 zh}lbo}q ge `g}n fbombpq# hfb 8> hom gcmbp/ Zh}lbo}q vl}n qbubpb ilmob| gp clubp

m|qeroa}lgo# hmml}lgohc qbplgrq crof agoml}lgoq# gp zpbulgrq b~zgqrpb }g loubq}lfh}lgohc mprfq gp mbulabq

vbpb b~acrmbm/ ]nb }plhc hcqg b~acrmbm zpbfoho} gp cha}h}lof vgkbo/ ]nb q}rm| vhq ogo+phomgkltbmhom gzbo ch`bc/ Gob fphk ge }nb q}rm| mprf vhq lo}phubogrqc| loerqbm gubp h egrp ngrp zbplgm/ ]nlq

}pbh}kbo} vhq pbzbh}bm bubp| blfn} ngrpq egp blfn} }g egrp}bbo mh|q/ Hcc zh}lbo}q vbpb ngqzl}hcltbm egp

}nb mrph}lgo ge }nbphz| hom klapg`lgcgflahc qhkzcbq vbpb agccba}bm }npgrfngr} }nb }pbh}kbo}/

Ch`gph}gp| hohc|qlq hom qheb}| hqqbqqkbo}q gaarppbm h} }nb }lkb ge bopgcckbo}# go mh| egrp hom mh| olob

ge }nbphz|# hom go }nb chq} mh| ge }nbphz|/ Aclolahc pbqzgoqb vhq buhcrh}bm qbubo }g egrp}bbo mh|q

egccgvlof }nb bom ge mprf hmklolq}ph}lgo hom cgof+}bpk aclolahc pbqzgoqb vhq fhrfbm }vbo}|+blfn} }g

}nlp}|+elub mh|q zgq}}nbphz|/81

Lo clfn} ge }nb EMH“q 0::6 hzzpguhc ge Mgplzbobk# 8= vb vlcc bkrch}b }nb znhqb LL }plhc mbqlfo rqbm }g

}bq} }nlq ho}l`lg}la/ Qlklchp }g }nb Mgplzbobk q}rm|# vb vlcc pbaprl} 0::+1:: zh}lbo}q hapgqq qbubphc ql}bqqreebplof epgk ogqgagklhc loeba}lgoq/ ]nb q}rm| vlcc loacrmb zh}lbo}q gubp hfb 8> ge `g}n fbombpq vl}n

og g}nbp qbplgrq gpfho lkzhlpkbo} ho}lalzh}bm }g lo}bpebpb vl}n }nb q}rm|/ @bahrqb kgq} ho}l`lg}la

aclolahc }plhcq pbq}pla} }nb loacrmbm lomlah}lgoq }g gob gp }vg achqqbq ge loeba}lgoq# vb vlcc cggi h} }vg

}|zbq ge loeba}lgoq4 zobrkgolh hom rplohp| }pha} loeba}lgoq/ Agoqlmbplof }vg achqqbq ge loeba}lgoq vlcc

loapbhqb }nb anhoabq ge lmbo}le|lof }nb kgq} beeba}lub rqb ge grp ho}l`lg}la/

]nb mgqbq hmklolq}bpbm lo }nlq znhqb LL }plhc vlcc `b `hqbm rzgo }nb pbqrc}q ge zpbaclolahc q}rmlbq hom

kgmbclof/ Hq lo }nb Mgplzbobk }plhc# }nb cbriga|}b mprf vlcc `b hmklolq}bpbm lo}phubogrqc| lo h ngqzl}hc

qb}}lof gubp h }lkb zbplgm agoqlq}bo} vl}n }nb bq}h`clqnbm ZI'ZM }hpfb}q egp }nb mprf/ ]nb q}rm| vlcc

5






ago}lorb egp hzzpg~lkh}bc| 8+0 vbbiq# }ngrfn }nb b~ha} mrph}lgo vlcc `b mbzbombo} go zpbaclolahc hom

znhqb L q}rm| mh}h/ Klapg`lgcgfla qhkzcbq vlcc `b pgr}lobc| agccba}bm }g hqqbqq `ha}bplhc pbqzgoqb/

Qheb}| hqqbqqkbo}q vlcc `b agomra}bm h} pbfrchp lo}bpuhcq mrplof }nb q}rm| hom zh}lbo}q vlcc `b pbkgubm

epgk }nb q}rm| `hqbm go }nblp ul}hc qlfoq hom ch`gph}gp| pbqrc}q/ Zh}lbo}q vlcc `b buhcrh}bm egccgvlof

vl}nmphvhc gp }nb agkzcb}lgo ge }nbphz| hom hcc hmubpqb bubo}q vlcc `b mgarkbo}bm/

Znhqb LLL ]plhc MbqlfoQraabqqerc znhqb LL pbqrc}q vlcc boh`cb rq }g kgub egpvhpm vl}n h ago}pgccbm znhqb LLL aclolahc }plhc/ Lo

mbqlfolof grp znhqb LLL }plhc# vb krq} q}plub }g rzngcm b}nlahc q}homhpmq vnlcb hcqg mbqlfolof h q}rm| }g

|lbcm rqberc mh}h/ ]nb b}nlahc anhccbofbq qrppgromlof mbqlfolof znhqb }npbb aclolahc }plhcq egp ho}l`lg}laq

hpb pbecba}bm lo }nb cgv ork`bpq ge ogubc ho}l`lg}laq lo mbubcgzkbo}/ Achqqlahc zchab`g+ago}pgccbm }plhcq

hpb rob}nlahc `bahrqb qbubpb `ha}bplhc loeba}lgoq hpb ge}bo eh}hc le cbe} ro}pbh}bm/ Lo clbr ge zchab`g+

ago}pgccbm q}rmlbq# znhqb LLL q}rmlbq lkzcbkbo} ogo+loebplgpl}| }plhc mbqlfo `| }bq}lof ho ha}lub

agkzhph}gp hfhloq} }nb rohzzpgubm mprf/ ]nbqb }plhcq# hcqg ahccbm ha}lub+agkzhph}gp ago}pgccbm q}rmlbq#

agkzhpb }nb }plhc mprf }g ho b~lq}lof }nbphz| lo gpmbp }g lomlpba}c| mbkgoq}ph}b }nb }plhc mprf“q `bobel}gubp zchab`g vl}nlo }nb }plhc agoml}lgoq/ ]nb hzzpgubm mprf nhq mbkgoq}ph}bm `bobel} lo h zchab`g+

ago}pgccbm }plhc# qg qngvlof }nh} }nb }plhc mprf zbpegpkq h} cbhq} hq vbcc hq }nb hzzpgubm mprf lkzclbq h

`bobel} gubp zchab`g/ ]nb ib| }g }nlq }|zb ge q}rm| lq bq}h`clqnlof h khpflo ge ogo+loebplgpl}| zplgp }g }nb

q}rm|/ Ahpbercc| ahcarch}lof }nlq elfrpb vlcc `b lo}bfphc }g }nb qraabqq ge grp }plhc mrb }g }nb ago}pgubpq|

qrppgromlof kb}ngmq ge mb}bpklolof ogo+loebplgpl}| khpfloq/82

Vb vlcc r}lcltb }nlq }plhc mbqlfo `| bq}h`clqnlof h ogo+loebplgpl}| khpflo `hqbm go mh}h epgk zchab`g+

ago}pgccbm }plhcq ge ho hzzpgubm ho}l`lg}laq/ L} kh| `b obabqqhp| }g pbc| go nlq}gplahc mh}h le }nb ho}l`lg}la

rqbm lo grp q}rm| lq ho gcmbp mprf chailof pbabo} zchab`g+ago}pgccbm mh}h/ Zpgulof qrzbplgpl}| }g b~lq}lof

ho}l`lg}laq vl}nlo }nlq }plhc zhphmlfk aho `b b~}pbkbc| mleelarc} `bahrqb loeba}lgoq }nh} hpb pbqlq}ho} }g

}nb ha}lub agkzhph}gp krq} `b b~acrmbm epgk }nb q}rm| egp b}nlahc pbhqgoq/ Le }nb `ha}bplh hpb qboql}lub }g}nb ha}lub agkzhph}gp# }nbo }nb loeba}lgo vlcc rqrhcc| `b pbqgcubm/ Le }nb `ha}bplh mbubcgz pbqlq}hoab

mrplof }nb agrpqb ge }pbh}kbo} hom }nbpb lq hog}nbp ho}l`lg}la }nh} aho `b rqbm# }nb zh}lbo} vlcc obbm }g `b

pbkgubm epgk }nb q}rm|/ ]nrq# l} lq lkzgp}ho} }g agoqlmbp g}nbp hmuho}hfbq }nb }plhc mprf kh| geebp qran

hq lkzpgubm qlmb beeba}q# bhqlbp hmklolq}ph}lgo# gp cgvbp agq}/ Pbkhlolof agfoltho} ge lo}bpoh}lgohc

pbfrch}gp| pbxrlpbkbo}q qrppgromlof ogo+loebplgpl}| }plhcq vlcc `b lkzgp}ho} `bahrqb pbfrch}gp|

hr}ngpl}lbq hpb epbxrbo}c| loagoqlq}bo} lo }nblp qgcr}lgoq }g }nbqb mbqlfo lqqrbq/ Egp loq}hoab# lo qgkb

ahqbq# obv mprfq hpb pbxrlpbm }g khlo}hlo h abp}hlo cbubc ge }nb ha}lub agkzhph}gp“q beeba} gubp zchab`g/ 82

Grp znhqb LLL }plhc mbqlfo krq} khlo}hlo nlfn b}nlahc q}homhpmq hom boqrpb }nh} }pbh}kbo} lq og} mbch|bm/

Vb vlcc qbcba} }nb kgq} beeba}lub ha}lub agkzhph}gp mprf `| hohc|tlof egccgvlof pbqlq}hoab zh}}bpoq homhohc|tlof }nb qboql}lul}| ge }nb zpbulgrqc| mlqarqqbm `ha}bplh }g uhplgrq achqqbq ge ho}l`lg}laq/

Ho}l`lg}la qrqabz}l`lcl}lbq ge `ha}bplhc lqgch}bq vlcc `b buhcrh}bm rqlof }nb q}homhpm hfhp mlcr}lgo

kb}ngmq zpbqapl`bm `| OAACQ .Oh}lgohc Agkkl}}bb egp Aclolahc Ch`gph}gp| Q}homhpmq, frlmbclobq hom

agoqlmbplof }nb klolkhc lonl`l}gp| agoabo}ph}lgo ge lqgch}bq/8

Vb vlcc kgmbc grp znhqb LLL }plhc he}bp ho hzzpgubm znhqb LLL }plhc egp }nb ho}l`lg}la Mgplzbobk

qzgoqgpbm `| Dgnoqgo % Dgnoqgo/ Lo }nlq q}rm|# Mgplzbobk vhq agkzhpbm }g ho ha}lub agkzhph}gp

mprf# Kbpgzbobk# lo ngqzl}hcltbm anlcmpbo vl}n agkzclah}bm lo}ph+h`mgklohc loeba}lgoq/ ]ngrfn }nlq

q}rm| vhq h qkhccbp }plhc egarqlof go }nb mprf“q qheb}| lo anlcmpbo# l} zpgulmbq h fggm }bkzch}b egp ho

6






ha}lub+agkzhph}gp ago}pgccbm ho}l`lg}la }plhc/ ]nb }plhc vhq h mgr`cb hpk# phomgkltbm# mgr`cb+`clom#

krc}labo}bp# krc}loh}lgohc q}rm|/ @bahrqb }nlq q}rm| }hpfb}bm h ubp| qzbalela zgzrch}lgo# goc| 8=:

anlcmpbo h} == ql}bq vbpb bopgccbm/ ]nb q}rm| vhq gzbo }g anlcmpbo hfb }npbb kgo}nq }g blfn}bbo |bhpq

vl}n agkzclah}bm h`mgklohc loeba}lgoq pbxrlplof ho}l`lg}la }pbh}kbo}/ Anlcmpbo vl}n hccbpfla pbha}lgoq }g

ho}l`lg}laq gp loeba}lgoq ahrqbm `| `ha}bplh iogvo }g `b pbqlq}ho} }g }nb }plhc mprfq vbpb b~acrmbm/ ]nb

q}rm| hcqg b~acrmbm anlcmpbo vl}n `cggm h`ogpkhcl}lbq gp pbohc lkzhlpkbo}/85

]nb q}rm| vhq `pgibo mgvo lo}g }npbb mlq}loa} zhp}q/ Elpq}# zh}lbo}q vbpb qapbbobm hom }nbo phomgkltbm

vl}nlo }vg mh|q/ Ob~}# ngqzl}hcltbm zh}lbo}q vbpb }pbh}bm vl}n gob ge }nb lo}phubogrqc| hmklolq}bpbm

ho}l`lg}laq egp elub }g egrp}bbo mh|q/ Egccgvlof }nb ho}l`lg}la }nbphz|# zh}lbo}q h}}bombm }vg egccgv+rz

ulql}q/ Ho}l l̀g}laq vbpb goc| hmklolq}bpbm egp h kh~lkrk ge egrp}bbo mh|q hom }nb }g}hc q}rm| }lkb#

loacrmlof zgq} }nbphz| ulql}q# vhq qbubo }g blfn} vbbiq/ @hqbm go h zh}lbo}“q q}h}rq# mga}gpq vbpb flubo

}nb gz}lgo }g qvl}an zh}lbo}q }g gphc ho}l`lg}laq mrplof }nb q}rm|/ Dgnoqgo % Dgnoqgo vgpibm vl}n ho

lombzbombo} kgol}gplof agkkl}}bb .LMKA, }nh} loacrmbm h klolkrk ge gob q}h}lq}lalho hom gob

loeba}lgrq mlqbhqb zn|qlalho }g kgol}gp }nb zh}lbo}q“ qheb}|/85

Qlklchpc|# grp znhqb LLL }plhc vlcc `b ho ha}lub+agkzhph}gp ago}pgccbm# phomgkltbm# mgr`cb+`clombm q}rm|

ge }nb qheb}| hom beelaha| ge ho lo}phubogrqc| hmklolq}bpbm ho}l`lg}la/ Clib Dgnoqgo % Dgnoqgo“q }plhc#

vb vlcc loacrmb gob hpk egp }nb }plhc mprf hom gob hpk egp }nb ha}lub agkzhph}gp/ Kl~bm mh}h go vnb}nbp

agk`loh}lgo }nbphz| lq `b}}bp gp vgpqb }nho kgog}nbphz| 6 nhub zpgkz}bm rq }g hmm h }nlpm hpk lo vnlan

}nb }plhc hom ha}lub agkzhph}gp mprfq vlcc `b rqbm lo agk`loh}lgo }nbphz|/ Mrb }g }nb b}nlahc

lkzclah}lgoq ge mbo|lof beeba}lub }pbh}kbo}# vb kh| `b pbxrlpbm }g zchab goc| }ngqb zh}lbo}q vl}n

loeba}lgoq ahrqbm `| zh}ngfboq pbqlq}ho} }g hcc ho}l`lg}laq lo }nb hpk pbablulof goc| }nb }plhc mprf/

]nb lomlah}lgo kgq} qraabqqerc lo grp znhqb LL q}rm| vlcc `b }nb egarq ge }nb znhqb LLL q}rm|/ Egp

b~hkzcb# le }nb mprf }pbh}q zobrkgolh beeba}lubc| lo znhqb LL# grp znhqb LLL q}rm| vlcc haabz} zh}lbo}qqreebplof epgk ogqgagklhc zobrkgolh/ ]nb q}rm| vlcc loacrmb zh}lbo}q ge `g}n fbombpq# hfb 8> }g 52#

vl}n loeba}lgoq ahrqbm `| zh}ngfboq og} iogvo }g `b pbqlq}ho} }g bl}nbp }nb }plhc gp ha}lub agkzhph}gp

mprf/ L} vlcc `b lkzgp}ho} }g pbulbv bhan zh}lbo}“q nlq}gp| ge ho}l`lg}la }pbh}kbo} hq vbcc hq cgahc

`ha}bplhc bzlmbklgcgf| hom pbqlq}hoab `begpb hmkl}}lof nlk gp nbp }g }nb }plhc/ Zh}lbo}q pbabo}c| b~zgqbm

}g }nb ha}lub agkzhph}gp mprf vlcc `b b~acrmbm/6 Zh}lbo}q vl}n hmml}lgohc qbplgrq gpfho m|qeroa}lgo vlcc

hcqg `b b~acrmbm/

Vb lo}bom }g phomgkltb hom }pbh} hzzpg~lkh}bc| 1::: zh}lbo}q h} gubp h nrompbm aclolahc ql}bq lo }nb RQ#

Brpgzb# Hqlh# hom Qgr}n Hkbplah/ Zh}lbo}q vlcc `b qapbbobm# phomgkltbm hom }pbh}bm vl}n }nb }plhc mprf#

}nb ha}lub agkzhph}gp# gp `g}n egp h zbplgm ge hzzpg~lkh}bc| qbubo }g egrp}bbo mh|q/ Klapg`lgcgflahcpbqzgoqb hom qheb}| lomlah}gpq vlcc `b hqqbqqbm h} pbfrchp lo}bpuhcq mrplof }nb q}rm|/ Zh}lbo}q qngrcm `b

pbkgubm epgk }nb q}rm| le }nb loubq}lfh}gp mb}bpklobq }nh} }nb zh}lbo}“q aclolahc q}h}rq pbxrlpbq

hc}bpoh}lub lo}bpubo}lgo/ Le l} `bagkbq iogvo mrplof }nb q}rm| }nh} h zh}lbo}“q loeba}lgo lq ahrqbm `| h

zh}ngfbo pbqlq}ho} }g bl}nbp }nb q}rm| mprf gp }nb ha}lub agkzhph}gp# }nb zh}lbo} krq} hcqg `b pbkgubm

epgk }nb q}rm|/ Zh}lbo} bopgcckbo} vlcc `b mlqago}lorbm vnbo h qlfolelaho} }pbom hplqbq hkgof

agoelpkbm hmubpqb bubo}q/ Loubq}lfh}gpq vlcc boqrpb }nh} agkzcb}b bubo} mh}h egp hcc hmubpqb bubo}q vlcc

`b bo}bpbm lkkbmlh}bc| lo}g bcba}pgola ahqb pbzgp} egpkq/

>






Znhqb LLL ]plhc Mh}h hom Q}h}lq}laq]nb zplkhp| gr}agkb# qheb}|# vlcc `b hohc|tbm `| buhcrh}lof hmubpqb bubo}q# zn|qlahc b~hkloh}lgoq# hom

}pbomq lo ch`gph}gp| }bq} pbqrc}q mrplof hom he}bp }nb }pbh}kbo} zbplgm/ Beelaha| vlcc `b kbhqrpbm rqlof

}nb aclolahc arpb ph}b hom klapg`lgcgflahc pbqzgoqb ph}b hqqgalh}bm vl}n bhan }pbh}kbo}/ ]nb }bq} ge arpb

ulql}q egccgvlof }pbh}kbo} vlcc `b rqbm }g bq}h`clqn }nb aclolahc arpb ph}b/ ]nlq q}rm| vlcc hcqg hccgv rq }g

agoelpk mprf znhpkhagilob}laq lo }nb }hpfb} zgzrch}lgo/

Kgpb qzbalelahcc|# vb vlcc kbhqrpb pbqzgoqb ph}b86 ge }nb lkkrogagkzpgklqbm zh}lbo}q }nh} nhub

mbubcgzbm pbqlq}hoab }g agoubo}lgohc ho}l`lg}la kbmlah}lgo hom }nb }g~lal}|# 86 ge }nb cbriga|}b }pbh}kbo}

lo }nb }hpfb} zgzrch}lgo/ ]nb pbqzgoqb ph}b bom zglo} vlcc ̀ b ah}bfgpltbm lo}g }npbb bcbkbo}q4 8/ Zh}lbo}q

flubo goc| }nb HcclKbm Cbriga|}b }pbh}kbo}# 0/ HcclKbm zcrq agoubo}lgohc ho}l`lg}la }pbh}kbo}# 1/

Zh}lbo}q flubo goc| agoubo}lgohc ho}l`lg}la }pbh}kbo}/ ]nb pbqzgoqb ph}b vlcc `b mbelobm hq }nb

zbpabo}hfb ge zh}lbo}q b~zbplboalof h agkzcb}b gp zhp}lhc pbqzgoqb }g }nb }pbh}kbo}/ Egp }g~lal}|# vb vlcc

`b lo}bpbq}bm lo }nb }|zbq ge phpb qlmb beeba}q hplqlof epgk }nb mprf# bqzbalhcc| gubp }lkb hom lo

agodroa}lgo vl}n g}nbp kbmlalohc }pbh}kbo}q/

Zgq} }nbphz| buhcrh}lgoq vlcc `b qanbmrcbm vl}nlo }vbo}|+egrp ngrpq ge }nb chq} ho}l`lg}la mgqb# gob }g

}vg vbbiq zgq} }pbh}kbo}# hom egrp }g elub vbbiq zgq} }pbh}kbo}/ Lo hmml}lgo }g qheb}| buhcrh}lgoq

mrplof }pbh}kbo}# zh}lbo}q vlcc `b kgol}gpbm egp qheb}| hom hmubpqb bubo}q egp h }g}hc ge elub vbbiq

egccgvlof vl}nmphvhc gp agkzcb}lgo ge q}rm|+mprf }pbh}kbo}/ Agoqbxrbo}c|# }nb bo}lpb q}rm| agrpqb vlcc

chq} h`gr} qbubo vbbiq/

Lo gpmbp }g mphv agppba} agoacrqlgoq h`gr} grp }plhc# }nb mh}h agccba}bm krq} `b hohc|tbm rqlof agppba}

q}h}lq}lahc }bq}q/ ]nb }npbb hpkq ge grp }plhc pbzpbqbo} }npbb }pbh}kbo} fpgrzq agkzplqlof mleebpbo}

zh}lbo}q/ Hohc|qlq ge uhplhoab }bq}q qngrcm `b hzzclbm }g lo}bpuhc mh}h epgk }nb }plhc qran hq ul}hc qlfoq

hom klapg`lgcgflahc pbqzgoqb ph}bq/ Ogklohc mh}h# qran hq loeba}lgo q}h}rq .b/f/ arpbm gp og} arpbm,#vlcc `b hohc|tbm rqlof }nb Anl+qxrhpb hohc|qlq+ge+ago}lofboa| }h`cb/8> Hzzpgzplh}bc| hohc|tlof grp }plhc

mh}h vlcc hccgv rq }g khib ho loegpkbm mbalqlgo h`gr} vnb}nbp gp og} }g zpgabbm vl}n ho OMH/

@ha}bplhc Loeba}lgo Zpbubo}lgo]nb q}rm| zpg}gagc krq} }hib q}bzq }g pbmrab }nb plqi ge loeba}lgoq qzpbhmlof vl}nlo }nb ngqzl}hc qb}}lof/

Ago}pgcclof }nb }phoqklqqlgo ge loeba}lgrq `ha}bplh# bqzbalhcc| `b}vbbo aclolahc }plhc zh}lbo}q# vlcc `b

lkzbph}lub/ Ogqgagklhc loeba}lgoq hpb rqrhcc| }phoqkl}}bm }npgrfn zn|qlahc ago}ha} gp ago}hkloh}bm

kbmlahc bxrlzkbo}/ ]nbqb qgrpabq ge loeba}lgo aho `b hmmpbqqbm `| pbxrlplof q}plofbo} nhom vhqnlof

hom loq}l}r}lof fgvolof zpgabmrpbq egp nbhc}nahpb zpgulmbpq/ Ngqzl}hc q}hee krq} `b hzzpgzplh}bc|

}phlobm hom hmnbpb }g QGZq egp n|flbob# mbulab acbholof# hom }nb ecgv ge zbgzcb hom bxrlzkbo} lo }nbngqzl}hc vlcc `b vpl}}bo/ ]nb AMA“q –Frlmbclob egp Lqgch}lgo Zpbahr}lgoq4 Zpbubo}lof ]phoqklqqlgo ge

Loeba}lgrq Hfbo}q lo Nbhc}nahpb Qb}}lofq‛ vlcc frlmb grp zpbubo}lgo q}ph}bf|/>

Grp q}rm| zpg}gagc kh| hcqg lkzcbkbo} agngp}lof }g ago}pgc }nb qzpbhm ge `ha}bplh hom apgqq+

ago}hkloh}lgo ge mbulabq hom zbgzcb/ Agngp}lof lougcubq zchalof zh}lbo}q vl}n loeba}lgoq ahrqbm `| }nb

qhkb zh}ngfbo lo }nb qhkb hpbh }g klolkltb b~zgqrpb }g g}nbp `ha}bplh/ @bahrqb grp zh}lbo}q vlcc `b

nlfnc| lkkrogagkzpgklqbm# l} vlcc `b `bq} }g zchab }nbk lo zpluh}b pggkq/ Ngvbubp# ngqzl}hc vhpmq

vlcc `b gpfholtbm rqlof h agngp}lof q}ph}bf|/8> Mbqlfoh}lof h mleebpbo} fpgrz ge nbhc}nahpb zpgulmbpq egp

bhan fpgrz# vnbo zgqql`cb# vlcc hcqg pbmrab }nb plqi ge apgqq+ago}hkloh}lgo

<






Agq} Hohc|qlqVnlcb h vbcc+}ngrfn} gr} q}rm| mbqlfo lq }nb egromh}lgo ge h qraabqqerc aclolahc }plhc zpgfphk# vb krq}

q}bz `hai hom agoqlmbp }nb zpha}lahc ebhql`lcl}| ge grp zpgfphk/ ]nb egccgvlof buhcrh}lgo ge }nb agq}q

hqqgalh}bm vl}n h aclolahc }plhc rombpclobq }nb elohoalhc anhccbofbq qkhcc agkzholbq ehab/

Hq h aclolahc }plhc qzgoqgp# grp agkzho| lq pbqzgoql`cb egp hcc ge }nb agq}q hplqlof epgk zh}lbo} b~hkq#

qzbalhc }bq}lof# hom bkbpfboa| kbmlahc }pbh}kbo}/ ]nb hubphfb agq} zbp zh}lbo} egp go+ql}b }pbh}kbo} lo

}nb |bhp 0::: vhq hzzpg~lkh}bc| -52::/0: Agoqbxrbo}c|# h znhqb LLL q}rm| vl}n 1::: zh}lbo}q klfn}

bhqlc| loarp h }g}hc zh}lbo} ahpb agq} ge -8<#2::#:::/ G}nbp b~}bpohc agq}q loacrmb loq}l}r}lgohc ebbq hom

gubpnbhm agq}q# LP@ ebbq# APG ebbq# ha}lub agkzhph}gp mprf agq}q hom qr d̀ba} pblk`rpqbkbo}/

Pbulbvlof }nb q}rm| zpg}gagc hom h}}hanlof ho bq}lkh}bm agq} }g bhan q}rm| ha}lul}| ehalcl}h}bq }nb

apbh}lgo ge pgrfn `rmfb}/ ]nb egccgvlof elfrpb zpbqbo}q }nb bq}lkh}bm agq} zbp zh}lbo} egp go+ql}b zh}lbo}

ahpb lo h qhkzcb aclolahc }plhc/ L} lq lkzgp}ho} }g og}b }nh} }nb b~}bombm ngqzl}hc q}h|q pbxrlpbm egp grp

ho}l`lg}la q}rm| vlcc loapbhqb }nbqb agq}q qlfolelaho}c|/

Q}rm| Ha}lul}| Ork`bp ge Ulql}q Agq} zbp Ulql} B~zhombm Agq}Kbmlahc nlq}gp| 8 2: 2:Zn|qlahc b~hk 1 82: =2:Ch`q > 82: 80::BIF 1 0:: 5::Hmml}lgohc geelab ulql}q > 62 5::Zngob hqqbqqkbo}q 0 2: 8::Aggpmloh}gp }lkb > 2: =::Znhpkha| anhpfb > 12 0>:]g}hc -15>:Gubpnbhm ‑ 8:" -15>Fphom }g}hc zbp agkzcb}bm qr`dba} -=:=>

Elfrpb =/ H `pbhimgvo ge ql}b+pbch}bm agq}q egp bhan zh}lbo} lo h qhkzcb aclolahc }plhc/0:

]nb ahcarch}lgo hom qanbmrclof ge ql}b zh|kbo}q hom zh}lbo} pblk`rpqbkbo} krq} `b ahpbercc| agoqlmbpbm

hom lo}bfph}bm lo}g }nb q}rm| zpg}gagc/ Lmbhcc|# bhan ql}b vlcc pbablub ho lol}lhc zh|kbo} }g agubp LP@

ebbq hom q}hp}rz agq}q/ Epgk }nlq zglo}# zh|kbo} }g }nb aclolahc ql}bq kh| `b `hqbm go }nb pbablz} ge

agkzcb}bm zh}lbo} ahqb pbzgp} egpkq gp gaarp go h kgo}nc| qanbmrcb/ ]nb }h`cb `bcgv lccrq}ph}bq h

agkkgo ql}b zh|kbo} qanbmrcb egp h }plhc vl}n 8: zh}lbo}q `hqbm go h -02:: zbp zh}lbo} agq}/ Vb vlcc

b~zhom go }nlq kgmbc }g zcho grp ql}b zh|kbo}q egp chpfbp }plhcq/

8:






Zh|kbo} Klcbq}gob Hkgro}8 Lol}lhc zh|kbo} ) LP@ ebb rzgo ago}pha} b~bar}lgo -52::0 He}bp 1 qr`dba}q phomgkltbm -62::

1 He}bp 0 qr`dba}q agkzcb}bm -2:::= He}bp 0 qr`dba}q agkzcb}bm -2:::

2Elohc zh|kbo} he}bp hcc Ahqb Pbzgp} Egpkq hpbagkzcb}bm# xrbplbq hpb pbqgcubm hom acgqb+gr} ulql} lqagkzcb}b

-02::

Elfrpb 2/ H qhkzcb ql}b zh|kbo} qanbmrcb egp h }plhc vl}n 8: zh}lbo}q hom ho bq}lkh}bm agq} ge -02:: zbp zh}lbo}/0:

Hmml}lgohcc|# vb krq} ho}lalzh}b }nb lo}bpohc agq}q pbch}bm }g khohflof grp aclolahc }plhcq hom hohc|tlof

}nb }plhc mh}h/ Egp h qkhcc agkzho|# rombp}hilof ercc+qahcb aclolahc }plhcq vlcc obabqql}h}b nlplof

hmml}lgohc q}hee }g zpgabqq hom qrkkhpltb hcc ge }nb mh}h zpgmrabm `| }nb }plhcq/ ]nb egccgvlof }h`cb

zpbqbo}q ho bq}lkh}lgo ge }nb gzbph}lof agq}q hqqgalh}bm vl}n bhan zbpqgoobc pgcb/ ]nlq }|zb ge kgmbclofvlcc boh`cb rq }g mb}bpklob ngv chpfb ge h aclolahc }plhc zpgfphk vb aho qrq}hlo/

Obbmbm Gzbph}lof Agq}8 APH aho kgol}gp 8: +82 ql}bq 1 -=08#<>58 KM'ZnM aho khohfb 2:+62 ql}bq 8 -8=:#5508 q}h}lq}lalho aho hohc|tb 2+8: q}rmlbq'|bhp :/0 -0>#8108/2 ‑ 0/: mh}h }banolalhoq aho qrzzgp} 8 q}h}lq}lalho :/= -25#0528 zpgfphkkbp aho qrzzgp} 2+8: pbzgp}q'|bhp :/0 -0>#8108 kbmlahc vpl}bp aho zpbzhpb =+5 pbzgp}q'|bhp :/0 -0>#810]g}hc Agq} -6:1#18:

Elfrpb 5/ Bq}lkh}bm gzbph}lof agq}q ge q}hee pbxrlpbm }g qrzzgp} }nb khohfbkbo} ge h zlug}hc aclolahc }plhc/0:

Vl}n }nb clkl}bm pbqgrpabq hom khoreha}rplof ahzhal}| ge h qkhcc agkzho|# vb obbm }g hqqbqq grp h`lcl}|

}g zpgulmb h ago}lorgrq qrzzc| ge aclolahc }plhc kh}bplhc }g h krc}lql}b# krc}loh}lgohc }plhc/ Vb krq}

haagro} egp lo}bpohc agq}q loacrmlof }nb agq} ge phv kh}bplhcq# bxrlzkbo}# hom khoreha}rplof ehalcl}lbq/

Le vb chai }nb eromq }g `rlcm hom khlo}hlo khoreha}rplof ehalcl}lbq hzzpgzplh}b egp `lgcgflaq# ago}pha}

khoreha}rplof vgrcm ar} khoreha}rplof agq}q qlfolelaho}c|/

Le vb hpb h`cb }g khoreha}rpb aclolahc }plhc kh}bplhc lo+ngrqb# l} lq lkzgp}ho} }g `b hvhpb }nh} qkhcc

anhofbq lo mbkhom h} }nb aclolahc ql}bq hpb hkzclelbm }npgrfn }nb qrzzc| anhlo/ ]nh} lq# le }nb aclolahc

ql}b ho}lalzh}bq h obbm egp kgpb }plhc mprfq# }nb obbm `bagkbq hkzclelbm }npgrfn bhan cbubc ge aclolahcqrzzc| anhlo hom aclolahc khoreha}rplof/ ]nlq beeba} aho `b pbkbmlbm vl}n pbclh`cb kgmbclof zpgfphkq

hom gzbo agkkrolah}lgo anhoobcq `b}vbbo }nb loubq}lfh}lgohc ql}bq# aclolahc qrzzc| anhlo# aclolahc

khoreha}rplof hom agpzgph}b/ Qraabqqerc kgmbclof ge aclolahc mbkhom vlcc boqrpb }nb }plhcq pro

qkgg}nc| hom qhub }nb agkzho| kgob|/

Pbagrzlof }nb agq}q ge aclolahc }plhcq pbclbq nbhulc| rzgo q}ph}bfla khpib}lof mbalqlgoq/ Kgol}gplof

agkzb}l}gp“q }plhcq vl}n qlklchp zpgmra}q hom acgqbc| hohc|tlof grp gvo mh}h vlcc hccgv rq }g khib

loegpkbm anglabq h`gr} }nb zpgfpbqq ge grp }plhcq/ Le grp mh}h qrffbq}q }nh} }nb mprf vgrcm og} `b

hzzpgubm# vb aho }bpkloh}b grp aclolahc zpgfphk bhpc|/ Agoubpqbc|# le vb g }̀hlo zgql}lub mh}h# vb aho

88






`bflo zplklof }nb khpib} egp grp zpgmra}/

Zplklof }nb khpib} vgrcm `b haagkzclqnbm `| bmrah}lof }nb zr`cla h`gr} }nb apl}lahc oh}rpb ge

ho}l`lg}la+pbqlq}ho} `ha}bplhc loeba}lgoq/ Zr`claltlof }nb hzzbhphoab ge obv pbqlq}hoab kbanholqkq

hkgof `ha}bplhc zh}ngfboq vgrcm bkznhqltb }nb }npbh} ho}l`lg}la pbqlq}hoab zgqbq }g kgmbpo nbhc}nahpb/

Bhpc| ho}l`lg}laq hom agk`loh}lgo }nbphzlbq hpb goc| h }bkzgphp| hoqvbp }g }nlq zpg`cbk/ Vnlcb zprmbo}

ho}l`lg}la rqb hom ho}lklapg l̀hc q}bvhpmqnlz zpgfphkq hpb `bobelalhc# }nb| hpb zhp} ge h chpfbp qgcr}lgo

}nh} krq} loacrmb ogubc ho}l`lg}laq }g khib h qlfolelaho} lkzha}/

Agoacrqlgoq]nb mbuhq}h}lof agoqbxrboabq ge ho}l`lg}la pbqlq}hoab mbkhom }nb h}}bo}lgo ge }nb znhpkhabr}lahc

lomrq}p| hom fgubpokbo}hc nbhc}n hfboalbq/ ]nb EMH“q beegp}q }g boagrphfb ho}l`lg}la mbubcgzkbo} hom

}g agk`h} ho}lklapg`lhc pbqlq}hoab `bfho lo 8<<5 hom nhub mbubcgzbm lo}g h uhplb}| ge lol}lh}lubq lo

agcch`gph}lgo vl}n g}nbp ebmbphc nbhc}n hfboalbq/08 Kgpb pbabo}c|# }nb VNG mbachpbm }nb }nbkb egp

Vgpcm Nbhc}n Mh| 0:88 }g `b elfn}lof ho}lklapg`lhc pbqlq}hoab/00

Agkzholbq aho goc| hoqvbp }nlqanhccbofb `| vgpilof vl}n pbfrch}gp| hfboalbq }g mbqlfo hom b~bar}b vbcc+mbqlfobm beeba}lub# qheb# hom

b}nlahc aclolahc }plhcq/ @| apbh}lof h zpgzbp aclolahc }plhc zpgfphk vl}n haarph}b }hpfb} zgzrch}lgoq hom

xrho}lelh c̀b bom zglo}q# znhpkhabr}lahc agkzholbq aho `g}n zgql}lgo }nbkqbcubq egp h zg}bo}lhc

`cgai`rq}bp }pbh}kbo} hfhloq} pbqlq}ho} `ha}bplh hom zpgulmb h `b}}bp xrhcl}| ge cleb egp zh}lbo}q

vgpcmvlmb/

80






Pbebpboabq

8/ Vlccbkq P# ]gz D# Qho}bo K/ Fcg`hc Qzpbhm ge Uhoagk|alo+pbqlq}ho} Bo}bpgagaarq ehbalrk epgk Mlq}loa}

Ogqgagklhc Fbob}la Agkzcb~/ Bkbpflof Loeba}lgrq Mlqbhqbq/ 0::2988.5,4>08+>0>/

0/ Vgpcm Nbhc}n Gpfholth}lgo/ Ho}lklapg`lhc Pbqlq}hoab/ 3n}}z4''vvv/vng/lo}'kbmlhabo}pb'eha}qnbb}q'eq8<='bo'?

Haabqqbm Eb`prhp| 82# 0:80/

1/ Zrcalol A# @rqn I# Aphlf VH# b} hc/ Egpfg}}bo ho}l`lg}laq4 ho loubo}gp| lo Brpgzb# }nb Rol}bm Q}h}bq# Ahohmh#

hom Hrq}phclh/ Aclolahc Loeba}lgrq Mlqbhqbq/ 0:8092=.0,405>+6=/

=/ Chr}bo`han B# Zgci PB/ Pbqlq}ho} fphk+obfh}lub `halccl4 H obfcba}bm nbhc}nahpb aplqlq7 Hkbplaho Dgrpohc ge

Nbhc}n Q|q}bk Znhpkha|/ 0::695=.01 Qrzzc 8=,4Q1+089 xrlt Q00+=/

2/ R/ Q/ Eggm hom Mprf Hmklolq}ph}lgo/ Ehq} ]phai# Haabcbph}bm Hzzpguhc hom Zplgpl}| Pbulbv/3n}}z4''vvv/emh/fgu'egpagoqrkbpq'`|hrmlboab'egpzh}lbo}hmugah}bq'qzbbmlofhaabqq}glkzgp}ho}obv}nbphzlbq'rak

80>0<8/n}k? Haabqqbm Eb`prhp| 88# 0:80/

5/ Khannh U# Qzboabp Z# Kbpanho} K/ Beeba}q ge Cbriga|}b B~}pha} epgk }nb Hkbplaho Hcclfh}gp . Hcclfh}gp

klqqlqqlzzlboqlq, go Ho}l`lg}la+Pbqlq}ho} @ha}bplh/ ]nb Gzbo Tggcgf| Dgrpohc/ 0:889=4<+81/

6/ Nhrqbp HP# Qplphk Z/ Qbubpb Zqbrmgkgohq hbprflogqh loeba}lgoq4 ]haiclof }nb agoromprk ge mprf pbqlq}hoab/

Zgq}fphmrh}b Kbmlalob/ 0::29886.8,4=8/

>/ Abo}bpq egp Mlqbhqb Ago}pgc hom Zpbubo}lgo/ Icb q̀lbcch zobrkgolhb lo Nbhc}nahpb Qb}}lofq/

3n}}z4''vvv/ama/fgu'NHL'gpfholqkq'icb`qlbcch'icb`qlbcch/n}kc? Haabqqbm Eb`prhp| 6# 0:80/

</ MGB Dglo} Fbogkb Loq}l}r}b/ Bo}bpgagaarq ehbalrk MG/

3n}}z4''fbogkb/dfl+zqe/gpf'bo}eh'bo}eh/ngkb/n}kc? Haabqqbm Eb`prhp| 6# 0:80/

8:/ Vgpcm Nbhc}n Gpfholth}lgo/ Bo}bpgagaarq ehbalrk4 zpgzgp}lgo ge louhqlub lqgch}bq pbqlq}ho} }g uhoagk|alo/

3vvv/brpg/vng/lo}'WWmh}h'hqqb}q'///'khzqWBo}bpgagaarqWehbalrk/zme? Haabqqbm Eb`prhp| 8:# 0:80/

88/ ]nb Bagogkla ]lkbq/ Ngv qrzbp`rfq `bagkb pbqlq}ho} }g ho}l`lg}laq/

3n}}z4''hp}lacbq/bagogkla}lkbq/lomlh}lkbq/agk'0:80+:0+:8'obvq'18:81::<W8Wqrzbp`rfq+`ha}bplh+bot|kbq?

Haabqqbm Eb`prhp| 0:# 0:80/

80/ Znhfb ]nbphz| Abo}bp/ Bo}bpgagaarq qzz/ 3n}}z4''vvv/znhfb}nbphz|abo}bp/agk'zll'Zh}lbo}Qbpucb}7agkkhom;q}h}laWbo}bpgagaarq? Haabqqbm Eb`prhp| 88# 0:80/

81/ Aclolahc]plhcq/fgu/ Ho Beeba}lubobqq# Qheb}|# hom Klapg l̀gcgf| Q}rm| ge Mgplzbobk lo Zh}lbo}q vl}n

Ogqgagklhc .Ngqzl}hc+haxrlpbm, Zobrkgolh/

3n}}z4''aclolahc}plhcq/fgu'a}0'qngv'OA]::2:0>:87}bpk;ogqgagklhc)ho}l l̀g}la%phoi;0:? Haabqqbm Eb`prhp|

8:# 0:80/

8=/ R/Q/ Eggm hom Mprf Hmklolq}ph}lgo/ Mprf Mb}hlcq/

3n}}z4''vvv/haabqqmh}h/emh/fgu'qaplz}q'ambp'mprfqh}emh'lomb~/aek7erqbha}lgo;Qbhpan/MprfMb}hlcq? Haabqqbm

Eb`prhp| 0:# 0:80/

81






82/ Mhob H/ Ha}lub ago}pgccbm q}rmlbq lo ho}l̀ lg}la mprf mbubcgzkbo}/ Znhpkhabr}lahcq Q}h}lq}laq/

0:8898:.2,4=2=+5:/

85/ Aclolahc]plhcq/fgu/ H Qheb}| hom ]gcbph`lcl}| Q}rm| ge Mgplzbobk Agkzhpbm Vl}n Kbpgzbobk lo AnlcmpboNgqzl}hcltbm Vl}n Agkzclah}bm Lo}ph+h`mgklohc Loeba}lgoq/ 3n}}z4''aclolahc}plhcq/fgu'a}0'qngv'OA]:888:1>07

}bpk;mgplzbobk%phoi;=? Haabqqbm Eb`prhp| 8># 0:80/

86/ AhoabpFrlmb/ Aclolahc ]plhcq Mla}lgohp|/ 3n}}z4''ahoabpfrlmb/gpf'}plhcqWfcgqqhp|/n}kc? Haabqqbm Eb`prhp| 0:#

0:80/

8>/ Fcho}t QH/ Zplkbp ge @lgq}h}lq}laq/ 5}n bm/ Obv \gpi4 KaFphv+Nlcc Kbmlahc Zr`clqnlof Mlulqlgo9 0::2/

8</ Qlbfbc DM# Pnlobnhp} B# Dhaiqgo K# b} hc/ 0::6 Frlmbclob egp Lqgch}lgo Zpbahr}lgoq4 Zpbubo}lof ]phoqklqqlgo

ge Loeba}lgrq Hfbo}q lo Nbhc}nahpb Qb}}lofq/ 3n}}z4''vvv/ama/fgu'nlazha'0::6lz'0::6lqgch}lgozpbahr}lgoq/n}kc?

Haabqqbm Eb`prhp| <# 0:80/

0:/ Nlcc ]/ Ahcarch}lof }nb agq} ge Aclolahc Pbqbhpan/ Qaplz Khfhtlob/ Khpan 8<<=/

08/ R/Q/ Eggm hom Mprf Hmklolq}ph}lgo/ Ho}lklapg`lhc Pbqlq}hoab/

3n}}z4''vvv/emh/fgu'Mprfq'MprfQheb}|'Loegpkh}lgo`|MprfAchqq'rak8121==/n}k? Haabqqbm Eb`prhp| 81# 0:80/

00/ Vgpcm Nbhc}n Gpfholth}lgo/ Vgpcm Nbhc}n Mh| ‑ 6 Hzplc 0:88/

3n}}z4''vvv/vng/lo}'vgpcm+nbhc}n+mh|'0:88'bo'lomb~/n}kc? Haabqqbm Eb`prhp| ># 0:80/

8=

http://cancerguide.org/trials_glossary.html

http://cancerguide.org/trials_glossary.html

strategic clinical study design

Documents