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 11T H ANNUAL ME E T ING OF ISMPP 1
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. 11T H ANNUAL ME E T ING OF ISMPP 2
About MPIP T o de ve lo p a c ulture o f mutua l re spe c t, unde rsta nding , MPIP 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 Vision disse mina tio n o f re sults fro m industry-spo nso re d tria ls • 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 MPIP • I de ntify po te ntia l so lutio ns to inc re a se tra nspa re nc y a nd trust Obje c tive s • 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 http:/ / www.mpip-initia tive .o rg / We bsite 11T H ANNUAL ME E T ING OF ISMPP 3
MPIP’s Pe e r - Re vie we d Public ations • 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 • Ca ll to a c tio n to ra ise sta nd a rd s a nd • Only ind ustry-le d o ra l pre se nta tio n se le c te d stre a mline pub lic a tio n pro c e ss b y me e ting o rg a nize d b y JAMA/ BMJ 2009 2010 2011 2012 2013 2014 • Guid e to sub missio n “b e st pra c tic e s” Se r ve s as a platfor m for planning (tra nsla te d into Chine se ) futur e MPIP ac tivitie s 11T H ANNUAL ME E T ING OF ISMPP 4
MPIP’s F oc 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 o 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 s 1 , sub -o ptima l AE re po rt AE re po rting c o ntinue s to pe rsist 2 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 o 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 1 Jo hn P.A. I o 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. 11T H ANNUAL ME E T ING OF ISMPP 5 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.
Audie nc e Poll F or Adve r se E ve nt r e por ting in manusc r ipts, what aspe c ts pr ompt the most fe e dbac k fr om 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) 63 Re spo nde nts 11T H ANNUAL ME E T ING OF ISMPP 6
MPIP Adve r se E ve nt Re se a r c h Pr oje c t vie ws with • Co nduc te d qualitative inte r jo urna l e dito rs, industry e xpe rts, a nd c linic a l inve stig a to rs able disc ussio n with • Co nve ne d a Ro und T 9 jo urna l e dito rs a nd MPI P c o -spo nso rs to o b ta in a dditio na l input Qualitative Re se ar c h • Re a c h c o nse nsus o n c ur r e nt c halle nge s se e ve nt/ safe ty data with adve r Industr y c o mmunic a tio n in ma nusc ripts, a nd: E xpe r ts – 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 Jour nal Clinic al tra nspa re nc y – Disc uss re c o mme nda tio ns tha t c o uld E ditor s inve stigator s 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 o n this public atio n 11T H ANNUAL ME E T ING OF ISMPP 7
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 o ve rvie w ta b le , Qualitative a dditio na l AE displa ys b e yo nd Re se ar c h 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 Roundtable • 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 Re c omme ndation 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 11T H ANNUAL ME E T ING OF ISMPP 8
Disc ussion and Re c omme ndations Ce nte re d on T hre e Core Are as of a Manusc ript 1 2 3 Manusc r ipt T e xt Supple me ntal Data De sc r iptions Data 11T H ANNUAL ME E T ING OF ISMPP 9
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 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. 11T H ANNUAL ME E T ING OF ISMPP 10 2 http :/ / www.c tspe dia .o rg / do / vie w/ CT Spe dia / Sta tGra phHo me
T e xt De sc r iptions – Roundta ble Summa r y 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 o 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 11T H ANNUAL ME E T ING OF ISMPP 11
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 o 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 11T H ANNUAL ME E T ING OF ISMPP 12
Next Steps 1 • 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 Publish • Writte n jo intly b e twe e n industry pub lic a tio n Re c omme ndations re pre se nta tive s, jo urna ls e dito rs, a nd industry AE e xpe rts 2 • CONSORT c o nside re d the sta nda rd fo r Collabor ate with AE / sa fe ty re po rting g uida nc e Ke y Or ganizations • Co nside r o the r g ro ups a s ne e de d 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 Pr omote E duc ation imple me nta tio n and Uptake • 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 11T H ANNUAL ME E T ING OF ISMPP 13
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