22/ 02/ 2017 WOR KI NG GR OUP 4 : DI AL OGUE AND I NT E R - PowerPoint PPT Presentation

22/ 02/ 2017 WOR KI NG GR OUP 4 : DI AL OGUE AND I NT E R ACT I ON WI T H E T HI CS COMMI T T E E S Pirkko L e p o la E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 1

E nprE MA WG 4 - E thic s Curre nt WG4 me mbe rs sinc e 2016: ◦ Pirkko L e po la , Cha ir (F innish I nve stig a to rs Ne two rk fo r Pe dia tric Me dic ine s, F inla nd) ◦ Dia ne Ho ffma n, c o -Cha ir (Ja nsse n Re se a rc h & De ve lo pme nt, Phila de lphia , U.S.A.) ◦ Ma rtine De hling e r-K re me r (Synte ra c tHCR De utsc hla nd Gmb H, Ge rma ny) ◦ Jo Me ndum (PRA He a lthSc ie nc e s, Re a ding , UK ) ◦ Pe te r Sa lla b a nk (Re g ulinX, Surb ito n, UK ) ◦ Da vid Ne ub a ue r (Unive rsity Childre n’ s Ho spita l, L jub lja na , Slo ve nia ) ◦ Adria na Ce c i (CVBF -Co nso rzio pe r Va luta zio ni Bio lo g ic he e F a rma c o lo g ic he , I ta ly) ◦ Vivia na Gia nnuzzi (F o nda zio ne pe r la Ric e rc a F a rma c o lo g ic a Gia nni Be nzi, I ta ly) ◦ He idi Glo sli (Oslo Unive rsity Ho spita l, No rPe dMe d, No rwa y) 22/ 02/ 2017 E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 2

E nprE MA WG 4 - E thic s Role : De ve lop pra g ma tic re sponse s to be imple me nte d within six months (a pprox.); • E xample s of good pr ac tic e whe n E Cs c onside r tr ials r e lating to c hildr e n and young pe ople • De ve lop pr oposals to disse minate e xample s of good pr ac tic e to E Cs 22/ 02/ 2017 E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 3

E nprE MA WG 4 - E thic s t: Pla n Re po rt - Re c o mme nda tio ns (12), pub lishe d in De c e mb e r 2013 fo r E npr-E MA (o nly) • F ir st Re por able : “T o o l K it” - I nfo rme d Co nse nt a nd Asse nt fo r Pa e dia tric Clinic a l T ria ls in E uro pe • 1 T ask: De live r Publishe d on E npr - E MA we b- site on 18 De c e mbe r 2015 • tic le : “I nfo rme d Co nse nt and Asse nt T o o l Kit fo r Pae diatric Clinic al T rials in E uro pe ”; 1. Ar • Pub lishe d 25Ma y2016, Arc hive s o f Dise a se in Childho o d Author s: Pir kko L e pola , Allison Ne e dha m, Jo Me ndum, Pe te r Sa lla ba nk, Da vid Ne uba ue r , Sa skia de Wildt • Additional WG ac tivitie s in 2016: • • Contr ibution to PROPOSE D CHANGE S T O T HE U.S. COMMON RUL E Implic ations for Pe diatr ic Re se ar c h (F e de r al Polic y for the Pr ote c tion of Human Subje c ts) Comme nts submitte d on Ja nua ry 2016 by Ma rk T urne r, the be ha lf of the E npr- E MA • ask: T a ke pa rt to Pub lic Co nsulta tio n o f the “E thic al c o nside ratio ns fo r c linic al trials o n • Se c ond T me dic inal pro duc ts c o nduc te d with the pae diatric po pulatio n” (2008), o pe n June -Se pte mb e r 2016 • Contr ibute d by E F GCP CMWP (E ur ope an F or um for Good Clinic al Pr ac tic e , Childr e n’s Me dic ine s Wor king Par ty; WP 1 • In c ollabor ating with a small gr oup of PDCO me mbe r s 22/ 02/ 2017 E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 4

thic s E npr- E MA WG4 - E 3. T ask; 2016- 2017: Bac kgr ound fac ts: 1. Ne w E U CT Re g . (impl.a ppro x.10/ 2018) will ha rmo nise the c linic a l tria l a pplic a tio n (CT A) pro c e ss, b ut I C/ Asse nt issue s re ma in with e a c h Me mb e r Sta te . 2. T he re a re no tic e a b le diffe re nc e s b e twe e n na tio na l I C a nd a sse nt re q uire me nts in E uro pe due to na tio na l la ws a nd re g ula tio ns (Se e : T o o l K it da ta ) 3. T he se disc re pa nc ie s c a n pre se nt c ha lle ng e s fo r multic e ntre pa e dia tric CT s Planne d de live r able : “Par tly har monize d of IC / Asse nt te mplate s” Wa y to work: Isola te a nd c olle c t the issue s re pe a te dly c ome s to be solve d with ICs a nd Asse nts • Compile sta nda rd se c tions, re fle c ting the re vise d “E U Guide line ” a g e c a te g orie s • Re vie w a ll e xisting te mpla te s a nd ve rify those a lso with the “T ool Kit” da ta • Dra ft pa rtly ha rmonize d (a s muc h a s possible ) c ore te mpla te s (3 ?) with sta nda rd • la ng ua g e (E ng lish) Ma ke re c omme nda tions, wha t type of visua l a id c ould be use d, a nd wha t is public ly • a va ila ble . 22/ 02/ 2017 E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 5

E npr- E MA WG4 - E thic s 3. T a sk: E xe c ute d by a ”Mini- Gr oup of Conse nts” ◦ Dia ne Hoffma n : Jo hnso n & Jo hnso n Pe dia tric Ce nte r o f E xc e lle nc e (Cha ir) ◦ Ma xine Kindr e d : Jo hnso n & Jo hnso n Ope ra tio ns (Ope ra tio na l pro duc e r) ◦ He idi Glosi : Oslo Unive rsity Ho spita l (suppo rt) ◦ Jo Me ndum : CRO, PRA (suppo rt) 3.De live ra ble : Comparison of Asse nts from WHO, MCRN and F inland - Guida nc e te mpla te pro vide d Ja nua ry 2017* (*pa g e 7) BY; I de ntific a tio n o f a ll simila r e le me nts a c ro ss a sse nts • Pre pa re d to inc lude a ll e le me nts • I te ms inc lude d in the WHO te mpla te wa s a dde d to the g uida nc e • a s the y we re de e me d impo rta nt to the a sse nt 22/ 02/ 2017 E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 6

E npr - E MA WG4 - E thic s 1. Ide ntific ation of all similar e le me nts ac r oss asse nts 22/ 02/ 2017 E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 7

E npr - E MA WG4 - E thic s 1. Ide ntific ation of all similar e le me nts ac r oss asse nts, c ont. 2. Pr e par e d to inc lude all e le me nts & Ite ms inc lude d in the WHO te mplate was adde d to the guidanc e as the y we r e de e me d impor tant to the asse nt 22/ 02/ 2017 E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 8

E npr - E MA WG4 - E thic s 3. Ite ms inc lude d in the WHO te mplate 22/ 02/ 2017 E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 9

22/ 02/ 2017 E npr-E MA CG T C 20Ja n2017 / Pirkko L e po la 10