Clinical Resensych rd hoymacoUioilance.

ssignmend ovD:1
Clinicosuo/pes desions. i RCT LNOn- RCT

ubmi tled by
Sk. Som dunniso

R.rvo:0 ASIso60
y e a .Dinymary
Sem i-mid

Submitled to :

. Si deui Madom
M.pham (phO)
emamarl Dhos mocoty

TNTUk Schoo Dhosymacelicol Science Technolo9

4
 19
Clinttal tsial
eeoydtg o (aHtto elini.a oia Ony
yeAo0sch Stuuoya sjospec euely Diqns bumon pabirtipiostt
pitipiostt c6co7)
oup humans are t mou hea
mou haa syelaled tloyueoioD
Aaluale Th ekor on hoot oulowes

1teueolimt include dugs d

colls t a bioeoira
sucduts Susto o
Susoiol O9ocede Suodiarcqo oocedusj@ behoui eusyal

eomen,ooess o se Charge, syyen ltye Coy

eltnirolouols

)Dhase
he ensietuype o Stagtes tho 091 Cossid in
human
Sral no o hoalth
Subies, uduaS6nqur bo 0-80
Nole Psu ith
ignicon f qlertioltoxicituy
se uulu uolied in
9Cyoo
mlienle.
Psslior up o moSShndy o Singa devegf dugk
phnse--lsin 0 Subclk
deksymirl
-oimum sasoled doe
phosmorofkinilies
Dhosmacpdy nDmias
o meos us/mon
doug achvrtu
fAovayce forio elk ne ug
any
phase-t tt
hokse-ttouos 0y Covn'uod 0 DNO L D oUalunieev

LO.u DO-3e0

is ua dbung i hhes o/terc e Spoci

atsease
uoltn monh

his ohose mo y usedCo delleymin

heopeutt

Tobey¢e uo yoacltont ony

inal dose Tosn dosaoJolm

tsleyacio.
dug Tocltons.
PBk blind hy eAabuolerg e & e n o du

xUs.
Us. aue in liendt hpentton
Oase.
ase - ouol genooly Covduiled tn Cooo
L0
vp of
esple i.e 3e0-3e
hese Srudie Cordurled to
Srsndyar edabih
odd rora O.m o Juduro
phose- phae-itsuoli.
hese oiale usuoly @xpentiue e

dlut Ctut ondic ualu u

thi phaee Commed
Com tys»ed
uolion
twill uoutd odditiora tmal obsul
Sooy&o Sub-gs0upt.
dveye eeri
dbuug. tntearlioni,
hosmacoineltc nw duuo
Rk-bana nelmalio
q1-aoy o dsuug XUs. Std. (reatmen en haplen tton tunda,
base- u

Ohase tv olinical fsualt

eroun0s po 09celoa
Suuelance oualt

*Per 0oUO ceu duq phase-tV tuua beoin.

Purolion
9oing oous cg PoA oppovalNo red dusolion
i s u s lbuic doo it ofoned
Spidemo boio dat
wthin

populalian
osmoroeroronnut dalb.

CeyviCeyvi gialin (on-hypesi gesem ic) moofen undlay yode

rome oyes A Gpstrn bes yCmolre maal

os Coussed yemuscledegenoolion
Pestent o clinirol touals -

)paimerslal designs (orromised clinicasuo cRCT)

i)orordamiued elioical uia (Nan-RT

desonr)I
esesyualiana! destont (Nov-ex0eyinenal

Cahs uee
Cose. Constuo huudter
- Seliona tuudier,
org

4)Spesyjinsil designs t
xpeimenial Shudlter 0ye g7e wteye Jjedeoychy
tn7vodue an inesuenlton or Stuoaythe etfeclk
Expimeriol oier 0e imi oy t Coro Gudter
eR TFay tuotue éome rlioniisleyueltont&manipuulaugnr.

Him 1

Sieieooodtto eginl co couy

m ouo ) tovo
lo uid AP
molhm meosuio eecltvesess
eicienu healt
alh ruice ypuelton, Covstvo &reot men
al dueose &Cmoue hs heallh Communtty.

Types ordomiod Con:tvovin ardamied Cotealhsual,

WonSormamiua C)no expeyi men7o u a
lardomiz d Corstvo Tsial cReT)
ciolomalbqirol erposyimer n whith Subielt
fopalalion 0e 0dOmy oloralad ilo gsoups usual
Colled '
DT0 Qoup o
S10Ue
Hecoue expeyimenTal Boeuesiue C)Thaopeule obcedsye
moneUe C)tnteyuelion

ardomizalion the 0oA hith

oreomer 9s0upL
whith
olorain
olocaon o Subittle
Subscle
is doe b Canc
Chona wthoulth ab:lhu
houl tRobilttuy
to buoir oo it in who ou
Palinad bpabo.t

ormamied

Nautreomen
Cuentrealmen

tNo impsoued,
Imoued Impvoyed
AIloralion Seheme TH sûroomita.kon is dmu)
fokle S0dom u bRSS
amer 90upt 0s ino uoiead
di dtgu t 0-u
S-9 aiono -oenas ()
 6 Tyonslad 8 ABtan
89 BBBA A
Compu:hy garasailed ti
edig doto a h Codd to) ewen
yeoyc
the n8.o tres ospital sjeod
heedale olohith tray
09je tnuited o
li cpma in huday Codd eren daus)
amom Dumboy cbste Such as htUP:/1 Yadom .0ro
Juxpose andomizaliom_1

imosuy uspote ven 6a in olocoirg Subitlk o

reoimen gou! (uod (udicrabi ty
Sesoosu eIrdiue eompasohty bo e oup
t&ny eyhamic detaltor coom
my be Dn As in decion Covz ) Onaysis o huo,
Onoysi
tRal sjesuH in dirotiom K

cousyc bot I t.nyegal.

osiipont r otoll
3.
Stoliuuon
tesolksye
. Tnsumen
 Kardomialt onsio se 9old SHoslasyalt o rioydestgn
borOuse

Clasirauon ReT

.urOding o
blreipionl xousye.
3.hoyoico -o o ioipianle
. huooingo lvel o brding
apen OCT
Lo open RT
eUybooy touotued intois ows uhich
tlesuenlonis Qujen o oroicifubnt.

Sqotlied
plialnols irded

)Poukie bid
oulcome ualunl kouos o
Nostresiie
olnesi paies Osiqned.
tuch

d)tsalo bird
or frayico dolo na e btiaa
-o e l e der,t
.Fheotrg o piupont erposuse t i)halil
i) Crose-ote
Custe
voduo
 clhinica tusou
totesetouoimernAd Covol aloraed to die7
troiuidunl.
this Qsouup veoron o.b. ye even, So hol
N
Qs0up Sjecaiues ny 0
hay gvoup jeruives onyb.

ranolay opulal on.

ealm enl- weolmenl -B.

2uo.wo.to ultomes

iü) Cyoss-oUer desn

nthrtype Stasoies 20ch iest dves as his uo
Covilso. 2arh oten g e h tvearenle.

2arh piters SRrAiue Then u>asheulltm it

Boytded hen he uslmenl i
pouidad b Som
Somd,

Stuo
noal-A reolmenl-B

Dpulolt0n.
penl-
it clusta desion
covilsoledoiol hoyo tn goup
oup o
omom SoMomi alton

Sondomied o mads to cludsyt

totospoh.

clurdoy (ordomi alton.

eyyenlt on Corslso

hospilal

N : 1,O

Cot Seo
J e verion N:Seo

iu)orloio design
Studias uouer hile tonomniy ino -ae
calladoilesual
oloial decion p 0seos(e ha o touektos o oin
odepenrun trauioh
used ston i desiyed CSthwo Tkinfune o a 1o.of
a8s onoolari Comoed oswell 0 Tho tblsyaon
u deusleálmart elas om degerrasi Uasyiobu. ,
vealmel B.

Yalrer -A 8-ony

pvdccapion kir)v-o e.oual

)Mega fual
) Sn0nliahouo.
)N--Ore ual
ve tauia
cliotalhsun in
Stnoe lier
eltve u o , 0 Sirole Cose u
ne oipon erives e
expayimeslal erloyyenleonr
syes Corluo enlesuerDlton.
Mego oual 1
masiue climitaltoiol
troopai tnTovenlion oSevsin9 tua ue
eryolirg
Aubjeh.

deouenuoluual
itSolieutal nayit ajtuptan
08e o Speilibd ovevsoal befouhod
Lnsfeod touedtiools Conltnue uitirg ltuaonts
ustd o cleos benilrl oove o tasuailton it oesesved.
d) Vo-
Sodomied clinical Tual CNon. ReT).
delinilion
Stuudy cuheye oipiasls haue been 0Sigsed To

e fojeo7mon ro Con7of g0ups is no ono ,<Tha

tnueyigal Corotholbolion c

col)
he itp.anlt ye
o asSoioned
chnicalsiain whih in

p j e o i m e s Q50uDs.hottci puosl
mo
chanceo
whith q&ou hoy tan o be i col) Trey Oy
O be
chose
0ssdon Lo he G b B eeochuy.
Cont eo auial
Non adomized

GuasiexDeyimeia Stady

- sondom y igned Coso Oup Vuoies o a0

us e myale Aoups ye uauoled.

ourh
hurh 0cyes tneyueslion
Afy hol (yues o Colo co])
Comfasirion g0up.
sud, us i uked o ena thafual imfpainesvest
inesyveo7
anit-agl
On (opulalban haul Jomon osonmtnl.
1Keasons Nan-RcT
when he od Sosdam lbolig Suedut th efece
oy
-veness o fhe iolesyeilion
.CNhen uu be wohtoto do Sodo oooltom.
3. Calhen i tm0sackcal b do JOMom ololion.

2 Cos cs]) Covnuenients otot)

Calon odje ae leooAtliral obaclo o Osdom

alletoltom
6Calhen Sqese0yohsy Can onipula thirrleperlossl Uasyiohhs
6. Clhen 1eseaschay Con 0dom l0san paorlriipionls -Go

Guasi tnde peomenl Uayiable ts as0/y Duust osuiole

am Con be manipulalled t) elimionled.V

ypes Non-HCT e qe yeleve deion

n - e0ioles Corloos-pp destn
3) siesoungiled Tie Sasies
design.
1.he-qoup Da Te osf- test des t9n:
omtosisiom Oulcome Cckom Srundl
parttiAia
-nlt elae a D inltsjveolian u inlsoduad
he o
oy e de
odo n Th Same
attciiuoni
Cel is dilloosil ompes,
conalo bo Consictyed a 0n
PONimenlol deriyn
decon the toueignlot has Coo
0Uu])
Con be delnbeseoley monip.ot t tstounduc tieyvenlton.
 ime-J tveplon ime-.

ramle Sampb Uideslodalescos udmen.

mona9ont cloks
cos
veaTmeol rge
(eosuyet oGyestue oholrOy 0 u pot7 heolmtn

009esitve be hü/Buy Bus09a 1, Thon T,. we con

conc/ude thal ofecayease coused hy th Irolmen

.Nom- e0puivalent Conior design:

Srusdy

Teyuenlion Those wh measuyino h

Buultome
uT come uaiable se line o the tieyven/iop

uiod comnvin ThueM uinal Ugleuds Bup 0ye

omposO6le oelie C6)Ckoge Sen

a n olco
olco be COnsidesyed xpeyimesla desionih
inueylinol as Con
Coio oer Co) cap
delt basole ly anal
anula
eisosuclien toloyuenlion.

T g 9bpulalicn
sa Test Lkyyenlton k- oted

Solerlion

as-es
 3. ntesouupled ime
Sesyies design :
Rtes Omis Simgly
UosioblesCokan o /Osytew eme minls
sseshaly tho tovesqalmoasyo ouilcore o ileyer
esiahlish
Seuob mes belsu tniting tkeppojime
bes
seline Ualud am vene tdola.. tov e tlesyuenlian
The touetoa70 Ag0in measu Tko oul t o e euex0lTimer

emac o enloyvenlron
D
Oouyce ias in Nor- RCT

)L on. ondom td Stuulies Seletliom hio wt ba tlssduro

ehen
oici piost Cheoien pi
delleuni O7
tlouernlion hone
crosyarewidi co oe oltealed otCovl s0 Pup.
r e choite enlyyon/tom umsy hese rtumlances ilt
e tnunced onb 6 o clinution's 9wn psjsona
uyenta
cda iyuvecilton O/es oshsy olco
by foutipion ou/esyenes
oticiuosi chosyarlastslict claitol histouy
Obusyac
Relerences
Caitnlh, Side shosyo. ndclinitol Tunlype
Degnt
wou. Sueh bhoo. nl l p .
Yorlomized Clentcatoua .
3 Sebecule
guideliaiJsuugr a Cosmolies Soro
ules, 0 Minisuy Amerr'mant
taolth
fomily uelLps ,(Vuo Delhi