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1 1 TH A N N U A L M EETI N G O F I S M P P DE F INING BE ST PRACT ICE F OR ADVE RSE E VE NT RE PORT ING WIT H INDUST RY- SPONSORE D CL INICAL T RIAL MANUSCRIPT S April 28, 2015 Hya tt Re g e nc y Crysta l City

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SLIDE 1

11T H ANNUAL ME E T ING OF ISMPP 1

1 1 TH A N N U A L M EETI N G O F I S M P P

“DE F INING BE ST PRACT ICE F OR ADVE RSE E VE NT RE PORT ING WIT H INDUST RY- SPONSORE D CL INICAL T RIAL MANUSCRIPT S”

April 28, 2015 Hya tt Re g e nc y Crysta l City Arling to n, VA, USA

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SLIDE 2

11T H ANNUAL ME E T ING OF ISMPP 2

Disc laime r

I nfo rma tio n pre se nte d re fle c ts the pe rso na l kno wle dg e a nd o pinio n o f the pre se nte r a nd do e s no t re pre se nt the po sitio n o f he r c urre nt o r pa st e mplo ye rs, o r I SMPP.

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SLIDE 3

11T H ANNUAL ME E T ING OF ISMPP 3

About MPIP

MPIP Vision T

  • de ve lo p a c ulture o f mutua l re spe c t, unde rsta nding ,

a nd trust b e twe e n jo urna ls a nd the pha rma c e utic a l

industry tha t will suppo rt mo re tra nspa re nt a nd e ffe c tive disse mina tio n o f re sults fro m industry-spo nso re d tria ls MPIP Obje c tive s

  • Unde rsta nd issue s a nd c ha lle ng e s in pub lishing industry-

spo nso re d re se a rc h

  • I

de ntify po te ntia l so lutio ns to inc re a se tra nspa re nc y a nd trust

  • Pro mo te mo re e ffe c tive pa rtne rship b e twe e n spo nso rs

a nd jo urna ls to ra ise sta nda rds in me dic a l pub lishing MPIP We bsite

http:/ / www.mpip-initia tive .o rg /

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SLIDE 4

11T H ANNUAL ME E T ING OF ISMPP 4

MPIP’s Pe e r

  • Re vie we d Public ations

2009 2014 2010 2011 2012 2013

  • Inte rim re sults pre se nte d a t the Se ve nth Pe e r

Re vie w Co ng re ss in 2013

  • Only ind ustry-le d o ra l pre se nta tio n se le c te d

b y me e ting o rg a nize d b y JAMA/ BMJ

  • Ca ll to a c tio n to ra ise sta nd a rd s a nd

stre a mline pub lic a tio n pro c e ss

  • Guid e to sub missio n “b e st pra c tic e s”

(tra nsla te d into Chine se )

Se r ve s as a platfor m for planning futur e MPIP ac tivitie s

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SLIDE 5

11T H ANNUAL ME E T ING OF ISMPP 5

1 Jo hn P.A. I

  • a nnidis e t a l., Be tte r Re po rting o f Ha rms in RCT

: An E xte nsio n o f the CONSORT Sta te me nt, 2004. 2 Ca tia Ba ue r Ma g g i e t a l., I nfo rma tio n o n a dve rse e ve nts in RCT s a sse ssing drug inte rve ntio ns pub lishe d in fo ur me dic a l jo urna ls with hig h impa c t fa c to rs, 2014.

MPIP’s F

  • c us on Adve r

se E ve nts

  • Re po rting a dve rse e ve nt (AE

) da ta mo re tra nspa re ntly a nd in a mo re c linic a lly me a ning ful ma nne r is pa rt

  • f o ur “T

e n Re c o mme nda tio ns” hig hlig hte d b y e dito rs to c lo se the c re dib ility g a p

  • While the CONSORT

2004 Ha rms E xte nsio n Sta te me nt pro vide s g uida nc e to he lp c o lle c t a nd re po rt AE s1, sub -o ptima l AE re po rting c o ntinue s to pe rsist2

Why is this impor tant?

  • AE

re po rting pro vide s pra c tic a l info rma tio n tha t c linic ia ns ne e d to kno w to sa fe ly

  • ptimize pa tie nt c a re
  • Co ntinue d ne e d to e nsure AE

c la ims ma de in pub lic a tio ns a re a ppro pria te ly b a la nc e d a nd re fle c t limita tio ns o f the tria l de sig n

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SLIDE 6

11T H ANNUAL ME E T ING OF ISMPP 6

F

  • r

Adve r se E ve nt r e por ting in manusc r ipts, what aspe c ts pr

  • mpt the most fe e dbac k fr
  • m e ditor

s/ pe e r r e vie we r s?

  • A. Ba la nc e o f b e ne fit to risk info rma tio n 20% (13/ 63)
  • B. Use o f o ve rly b ro a d de sc riptive te rmino lo g y 19% (12/ 63)
  • C. Re le va nc e o f AE

da ta to the c linic a l a udie nc e

17% (10/ 63)

  • D. Sta tistic a l me tho do lo g y 6% (4/ 63)

E . Re q ue sts fo r a dditio na l sta tistic a l a na lyse s 38% (24/ 63)

Audie nc e Poll

63 Re spo nde nts

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SLIDE 7

11T H ANNUAL ME E T ING OF ISMPP 7

Qualitative Re se ar c h

MPIP Adve r se E ve nt Re se a r c h Pr

  • je c t
  • Co nduc te d qualitative inte r

vie ws with

jo urna l e dito rs, industry e xpe rts, a nd c linic a l inve stig a to rs

  • Co nve ne d a Ro und T

able disc ussio n with

9 jo urna l e dito rs a nd MPI P c o -spo nso rs to

  • b ta in a dditio na l input
  • Re a c h c o nse nsus o n c ur

r e nt c halle nge s with adve r se e ve nt/ safe ty data

c o mmunic a tio n in ma nusc ripts, a nd:

– Prio ritize tho se c ha lle ng e s tha t a llo w fo r

mo re c linic a lly me a ning ful c o mmunic a tio n a nd inc re a se d tra nspa re nc y

– Disc uss re c o mme nda tio ns tha t c o uld

a ddre ss the se c ha lle ng e s

  • Co llabo r

ate with 7 se nio r jo ur nal e dito r s who have agr e e d to se r ve as c o -autho r s

  • n this public atio n

Industr y E xpe r ts Jour nal E ditor s Clinic al inve stigator s

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11T H ANNUAL ME E T ING OF ISMPP 8

AE Roundtable Re c omme ndations

  • Cre a te mo re c linic a lly re le va nt da ta o utputs

use ful fo r c linic a l pra c tic e

– E

xa mple s: re le va nt AE

  • ve rvie w ta b le ,

a dditio na l AE displa ys b e yo nd inc ide nc e ta b le s, c le a r da ta c o lle c tio n a nd a na lysis me tho ds

  • He lp a utho rs unde rsta nd the limita tio ns o f

re po rting AE s fro m a sing le tria l vs. a n e ntire de ve lo pme nt pro g ra m

  • Avo id b ro a d sta te me nts suc h a s “g e ne ra lly

sa fe ” o r “we ll to le ra te d”, whic h a re uninfo rma tive fo r c linic ia ns a nd o fte n ra ise q ue stio ns

  • Unde rsta nd the impo rta nc e o f pa tie nt-le ve l

da ta to de te c t ra re o r une xpe c te d e ve nts fro m the la rg e r c linic a l pro g ra m a s a me a ns to b uild trust/ c re dib ility fo r ma nusc ripts

Re c omme ndation Roundtable Qualitative Re se ar c h

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SLIDE 9

11T H ANNUAL ME E T ING OF ISMPP 9

Disc ussion and Re c omme ndations Ce nte re d

  • n T

hre e Core Are as of a Manusc ript

Supple me ntal Data 3 T e xt De sc r iptions 2 Manusc r ipt Data 1

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SLIDE 10

11T H ANNUAL ME E T ING OF ISMPP 10

1 Amit O, He ib e rg e r R, a nd L a ne P, Gra phic a l Appro a c he s to the Ana lysis o f Sa fe ty Da ta fro m Clinic a l T ria ls, 2009. 2 http :/ / www.c tspe dia .o rg / do / vie w/ CT Spe dia / Sta tGra phHo me

Ma nusc r ipt Da ta – Roundta ble Summa r y

Call to Ac tion

Whe re po ssib le , pro vide a dditio na l AE da ta b e yo nd tra ditio na l a na lyse s

Jour nal E ditor Insights

  • 1. Co nside r inc luding fo llo wing da ta po ints in the ma nusc ript b o dy if

re le va nt: – Mo rta lity – T iming , dura tio n, a nd fre q ue nc y o f se le c te d re le va nt AE s – Disc o ntinua tio ns a nd suppo rting re a so n (e .g ., due to study drug , pa tie nt c ho ic e ) – Do se mo dific a tio ns a nd ho w AE s we re ma na g e d – Adhe re nc e to study me dic a tio n

  • 2. Ne w a ppro a c he s with a mo re visua l displa y o f AE

da ta c a n b e he lpful, whe re a ppro pria te 1,2

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SLIDE 11

11T H ANNUAL ME E T ING OF ISMPP 11

Call to Ac tion

E limina te o ve rly g e ne ra l sta te me nts a b o ut AE pro file to pre se nt a b a la nc e d a nd ho listic risk pro file in the ma nusc ript te xt

Jour nal E ditor Insights

  • 1. Avo id using g e ne ra l la ng ua g e o r phra se s to summa rize o ve ra ll AE

pro file

  • 2. I

n the re sults se c tio n, a im to e xpla in in a c o nc ise ma nne r the mo st re le va nt a spe c ts o f the risk/ b e ne fit pro file se e n in the tria l(s)

  • 3. F
  • r a b stra c t :

– Hig hlig ht the mo st re le va nt AE e ve nts; e nsure re sults a lig n with tho se pre se nte d in the ma in b o dy o f the ma nusc ript

T e xt De sc r iptions – Roundta ble Summa r y

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11T H ANNUAL ME E T ING OF ISMPP 12

Sta tistic a l Ana lysis – Roundta ble Summa r y

Call to Ac tion

Ho w to b e st inc o rpo ra te sta tistic a l a na lyse s o f AE / sa fe ty da ta to e nsure tra nspa re nt a nd b a la nc e d re pre se nta tio n o f da ta

Jour nal E ditor Insights

1. F

  • r AE

s o f pa rtic ula r inte re st, pre -spe c ify a na lyse s in sta tistic a l a na lysis pla n 2. Co nfide nc e inte rva l a ro und the diffe re nc e b e twe e n tre a tme nts sho uld b e stro ng ly c o nside re d 3. Ab so lute risk diffe re nc e b e twe e n tre a tme nt g ro ups (with a c o nfide nc e inte rva l) is g e ne ra lly mo re info rma tive tha n p-va lue s , pre -spe c ify if po ssib le – I f a na lyse s, inc luding se nsitivity a na lyse s, a re pe rfo rme d re tro spe c tive ly (e .g ., a t re q ue st o f jo urna l re vie we r) no te re tro spe c tive na ture in ma nusc ript a nd e dito ria l c o mmunic a tio ns 4. Whe n p-va lue s a re pro vide d (fo r pre -spe c ifie d sa fe ty e ndpo ints), ma rg ina lly sta tistic a lly insig nific a nt re sults, suc h a s a p-va lue = 0.06, sho uld re c e ive a dditio na l sc rutiny, sinc e the y ma y re pre se nt info rma tive a nd c linic a lly re le va nt re sults

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SLIDE 13

11T H ANNUAL ME E T ING OF ISMPP 13

Pr

  • mote E

duc ation and Uptake Collabor ate with Ke y Or ganizations Publish Re c omme ndations

  • CONSORT

c o nside re d the sta nda rd fo r AE / sa fe ty re po rting g uida nc e

  • Co nside r o the r g ro ups a s ne e de d
  • Pe e r-re vie we d pub lic a tio n in jo urna l with

wide a udie nc e fo r c linic a l tria l ma nusc ripts

  • Writte n jo intly b e twe e n industry pub lic a tio n

re pre se nta tive s, jo urna ls e dito rs, a nd industry AE e xpe rts

1 2 3

  • Wo rk with industry to ma p o ut a ppro a c h

a nd b e st pra c tic e s fo r upta ke a nd imple me nta tio n

  • Co ntinue to e duc a te ke y sta ke ho lde rs

a b o ut pub lishe d re c o mme nda tio ns a nd e dito r fe e db a c k

Next Steps

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11T H ANNUAL ME E T ING OF ISMPP 14

  • MPI

P is fo c use d o n de ve lo ping a c ulture o f mutua l re spe c t, unde rsta nding , a nd trust b e twe e n jo urna ls a nd industry

  • Pa st pub lic a tio ns pro vide ta ng ib le re c o mme nda tio ns, to o ls

a nd g uida nc e fo r industry pub lic a tio n pro fe ssio ns

  • Adve rse E

ve nts re po rte d in pub lic a tio ns a re no t ide a l fo r c linic ia ns

  • T

hro ug h q ua lita tive re se a rc h a nd e dito r fe e db a c k a numb e r

  • f insig hts into AE

re po rting we re ide ntifie d

  • MPI

P inte nds to pub lish a nd disse mina te re c o mme nda tio ns

  • n Adve rse E

ve nts re po rte d in me dic a l jo urna ls

Key Takeaways

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SLIDE 15

11T H ANNUAL ME E T ING OF ISMPP 15

QUE ST IONS?

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SLIDE 16

11T H ANNUAL ME E T ING OF ISMPP 16

Re me mbe r ing Mar y Whitman

  • Pa ssio na te a b o ut tra nspa re nc y a nd e thic s in

me dic a l pub lic a tio ns, a s we ll a s a lo ng -time me mb e r

  • f I

SMPP.

  • T

a le nte d sc ie ntist a nd write r who ha s b e e n a me mb e r o f Ja nsse n Bio te c h I mmuno lo g y a nd Onc o lo g y Me dic a l Affa irs fa mily fo r ne a rly 13 ye a rs, whe re she b uilt a ro b ust me dic a l writing de pa rtme nt.

  • T
  • o k g re a t pride in a dva nc ing sc ie nc e , while

ma inta ining the hig he st q ua lity, a nd c o mplia nc e sta nda rds.

  • Ha d a pa ssio n fo r tra ining a nd e duc a ting o the rs, a nd

vo lunte e re d he r time to spe a k a ro und the c o untry a s a n a utho rity o n me dic a l writing b e st pra c tic e s.

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11T H ANNUAL ME E T ING OF ISMPP 17

1 1 TH A N N U A L M EETI N G O F I S M P P

“DE F INING BE ST PRACT ICE F OR ADVE RSE E VE NT RE PORT ING WIT H INDUST RY- SPONSORE D CL INICAL T RIAL MANUSCRIPT S”

April 28, 2015 Hya tt Re g e nc y Crysta l City Arling to n, VA, USA