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

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

22/ 02/ 2017

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
• 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)

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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
• posals to disse minate e xample s of

good pr ac tic e to E Cs

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E nprE MA WG 4 - E thic s

• F

ir st Re por 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)

• 1 T

ask: De live r able : “T

• 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

• Publishe d on E

npr

• E

MA we b- site on 18 De c e mbe r 2015

• 1. Ar

tic le : “I

nfo rme d Co nse nt and Asse nt T

• o l Kit fo r Pae diatric Clinic al T

rials in E uro pe ”; 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

• te 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

• Se c ond T

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 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

• pe an F
• r

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

• up of PDCO me mbe r

s

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E npr- E MA WG4 - E thic s

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• 3. T

ask; 2016- 2017: Bac kgr

• und 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 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
• ol 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 .

E npr- E MA WG4 - E thic s

• 3. T

a sk: E

xe c ute d by a ”Mini- Gr

• up 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

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E npr

• E

MA WG4 - E thic s

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• 1. Ide ntific ation of all similar

e le me nts ac r

• ss asse nts

E npr

• E

MA WG4 - E thic s

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• 1. Ide ntific ation of all similar

e le me nts ac r

• ss 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

E npr

• E

MA WG4 - E thic s

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• 3. Ite ms inc lude d in the WHO te mplate

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