1
A new, in e disciplina y, mul i-
s akeholde Eu opean ne wo k o imp o e
heal hca e se ices, esea ch and ou comes o Adolescen s and Young Adul s
wi h cance .
STRONG-AYA – No. 101057482 – D2.4
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Deli e able Repo
WP2– Go e nance, Da a Secu i y and E hics
Deli e able D2.4
STRONG AYA e hics epo , wi h in e im epo s ollowing e hics wo kshops
Due da e o deli e able: 30/09/2024
Ac ual submission da e: 15/05/2025
P ojec : STRONG-AYA
Lead Con ibu o S ephane Lejeune (EORTC)
Email s ephane.lejeune@eo c.o g
O he Con ibu o s
Emails
Due da e
30 09 2024
Deli e y da e
15 05 2025
Deli e able ype
R
Dissemina ion le el PU
Desc ip ion o Wo k Ve sion Da e
Final e sion o epo
a e app o al o ERAB
V1.0 30/04/2025
STRONG-AYA – No. 101057482 – D2.4
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Desc ip ion:
STRONG-AYA E hics epo , wi h in e im epo s ollowing E hics wo kshops (yea 1)
Publishable summa y (max ½ page)
This deli e able is he epo o he second mee ing (4 Ma ch 2025) o he STRONG-AYA E hics and
Regula o y Ad iso y Boa d (ERAB). The ERAB aims o p o ide he conso ium wi h an independen iew on
he e hics and legal challenges as well as he mi iga ion ac ions planned o al eady implemen ed by he
conso ium. The ERAB is composed o ou independen expe s in e hics and/o legal aspec s. The ERAB
mee s each yea oge he wi h conso ium ep esen a i es. This epo has been app o ed by he ou
independen expe s and by he p ojec ep esen a i es who a ended he mee ing.
STRONG-AYA – No. 101057482 – D2.4
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1 Table o Con en s
PUBLISHABLE SUMMARY (MAX ½ PAGE) .................................................................................................................... 3
1 TABLE OF CONTENTS .......................................................................................................................................... 4
2 DEFINITIONS....................................................................................................................................................... 5
3 ABBREVIATIONS ................................................................................................................................................. 6
4 INTRODUCTION .................................................................................................................................................. 7
PROJECT BACKGROUND ........................................................................................................................................... 7
DELIVERABLE INTRODUCTION .................................................................................................................................... 8
5 RESULTS ......................................................................................................... ERROR! BOOKMARK NOT DEFINED.
6 CONCLUSION .................................................................................................. ERROR! BOOKMARK NOT DEFINED.
7 REPOSITORY FOR PRIMARY DATA (ANNEX) .................................................... ERROR! BOOKMARK NOT DEFINED.
STRONG-AYA – No. 101057482 – D2.4
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2 De ini ions
STRONG AYA conso ium membe s a e e e ed o as ollowing wi hin his ex :
1. NKI-AVL – S ich ing he Nede lands Kanke Ins i uu – An oni an Leeuwenhoek Ziekenhuis (NL)
2. YCE – You h Cance Eu ope (RO)
3. INT – Fondazione IRCCS Ins i u o Nazionale dei Tumo i (IT)
4. FFUND – FFUND BV (NL)
5. CLB – Cen e de Lu e Con e le Cance Leon Be a d (FR)
6. ECO – Eu opean Cance O ganisa ion (BE)
7. UNIMAAS – Uni e si ei Maas ich (NL)
8. IKNL – S ich ing In eg aal Kanke cen um Nede land (NL)
9. EORTC – Eu opean O ganisa ion o Resea ch and T ea men o Cance AISBL (BE)
10. IGR – Ins i u Gus a e Roussy (FR)
11. MSCNRIO – Na odowy Ins y u Onkologii im. Ma ii Sklodowskiej-Cu ie – Pans wowy Ins y u
Badawczy (Ma ie Sklodowska-Cu ie Na ional Resea ch Ins i u e o Oncology) (PL)
12. UOM – Uni e si y o Manches e (UK)
13. UOL – Uni e si y o Leeds (UK)
14. LTHT – Leeds Teaching Hospi als Na ional Heal h Se ice T us (UL)
15. SOUTHAMPTON – Uni e si y o Sou hamp on (UK)
• G an Ag eemen (including i s annexes and amendmen s): he ag eemen signed be ween he
bene icia ies o he HORIZON Resea ch and Inno a ions Ac ions (he ea e e e ed o as Ho izon)
and he Eu opean Heal h and Digi al Execu i e Agency (he ea e e e ed o as HADEA) o he
unde aking o he STRONG AYA p ojec (G an Ag eemen no. 101057482).
• Bene icia y: Signa o ies o he G an Ag eemen
• Associa ed Pa ne : En i ies which pa icipa e in he ac ion bu wi hou he igh o cha ge cos s o
claim con ibu ions.
• P ojec : he sum o all ac i i ies ca ied ou in he amewo k o he G an Ag eemen .
• Conso ium: he STRONG AYA conso ium, including all he a o emen ioned pa ne s.
• Conso ium Ag eemen : The ag eemen made be ween STRONG AYA membe s o he
implemen a ion and execu ion o he ac ion ou lined in he G an Ag eemen . The ag eemen shall
no a ec he pa ies’ obliga ions o HADEA on behal o he Eu opean Union, and/o o one ano he
a ising om he G an Ag eemen .

STRONG-AYA – No. 101057482 – D2.4
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3 Abb e ia ions
Ac onym/Abb e ia ion
Meaning
HCP
Heal h Ca e P o ide
PRO
Pa ien Repo ed Ou come
PROM
Pa ien
Repo ed Ou come Measu e
COS
Co e Ou come Se
WP
Wo k Package
WPL
Wo k Package Lead(s)
WP1
Wo k Package 1 (De elopmen Co e Ou come Se
AYA wi h cance & da a collec ion)
WP2
Wo k Package 2 (Go e nance, Da a Secu i y and
E hics)
WP3
Wo k
Package 3 (In as uc u e and In e ope abili y)
WP4
Wo k Package 4 (Ope a ion o STRONG AYA
ecosys ems, s akeholde and pa ien in ol emen ,
dissemina ion, exploi a ion, communica ion)
WP5
Wo k Package 5 (Scien i ic coo dina ion and p ojec
managemen
)
KPI
Key Pe o mance Indica o
OA
Open Access
PAB
Pa ien Ad iso y Boa d
EC
Eu opean Commission
HADEA
Eu opean Heal h and Digi al Execu i e Agency
SC
S ee ing Commi ee
MT
Managemen Team
ERAB
E hics and Regula o y Ad iso y Commi ee
STRONG-AYA – No. 101057482 – D2.4
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4 In oduc ion
P ojec backg ound
Cance a adolescen and young adul (AYA) age (15-39 a p ima y diagnosis) is a e. Howe e , his a i y does
no e lec he signi ican pe sonal and socie al cos s o cance in his popula ion, as e lec ed in he po en ial
yea s o li e los o sa ed, he dec eased p oduc i i y and quali y-o -li e due o he impac o he disease
du ing o ma i e yea s, and he long- e m complica ions o disabili ies1. AYAs wi h cance o m a unique
g oup; hey ace age-speci ic issues (e.g. In e ili y, unemploymen , inancial p oblems) and dec eased quali y
o li e due o cance and i s ea men . Unlike dedica ed heal hca e and ials o paedia ic cance pa ien s,
AYA-speci ic heal hca e se ices a e sca ce and a y ac oss Eu ope. AYAs who a e a he co e o socie y and
he economy need access o age-app op ia e and high-quali y heal hca e.
The STRONG-AYA p ojec aims o ackle he unde ep esen a ion o AYA’s expe iences and ou comes when
na iga ing he heal hca e sys em and in clinical ca e by de eloping na ional in as uc u es o ou come da a
managemen and clinical decision-making wi hin a pan-Eu opean ecosys em and es ablishing
communica ion eedback o AYAs wi h cance and he heal hca e sys ems. This will be key o imp o ing
heal hca e se ices, esea ch, ou comes and policies o AYAs and o ul ima ely be e cance ca e o his
pa ien g oup. The p ojec b ings oge he an in e na ional mul i-disciplina y conso ium
(academic/ esea ch, clinical, s akeholde and pa ien o ganisa ions) ac oss se en Eu opean coun ies.
Building on p e ious ini ia i es, a STRONG-AYA da a ecosys em will be se up o alue-based ca e, esea ch
and policy o AYA wi h cance by:
1. De eloping a Co e Ou come Se (COS) speci ically o AYAs wi h cance , ia a pa icipa i e
consensus p ocess de ining mos impo an aspec s o hose di ec ly a ec ed by AYA cance ,
including pa ien s and heal hca e p o essionals.
2. Implemen ing he COS ac oss se e al na ional Eu opean heal hca e sys ems. Da a will be
collec ed a local le el and will hen be included in a da a in eg a ion pla o m. An o e all
ecosys em amewo k o da a analy ics and ou pu will be c ea ed suppo ing ede a ed
analyses and he c ea ion o epo s ac oss clinical and pa ien - epo ed da a and making
na ional eposi o ies o (pa ien - epo ed) heal h da a, a ailable o indi idual pa ien s, pa ien
o ganisa ions, egula o y au ho i ies, as well as he pa ien s’ heal h ca e p o ide s o in o m
clinical decision-making. The i e esul ing na ional ecosys ems will be connec ed o each o he
in o he pan-Eu opean ecosys em using a ede a ed app oach also u ilizing he o e all
ecosys em amewo k.
3. Dissemina ing he COS o a wide ange o local as well as pan-Eu opean s akeholde s, in
pa icula by de eloping analy ical ools o p ocess and p esen pa ien ou come da a and
es ablish eedback loops ha in o m pa ien s and clinicians.
Implemen ing hese p ojec objec i es a e i e wo k packages wi hin he STRONG-AYA p ojec :
• WP1: De elopmen Co e Ou come Se AYA wi h cance and Da a Collec ion (Lead: SOUTHAMPTON)
• WP2: Go e nance, Da a Secu i y and E hics (Lead: EORTC)
• WP3: In as uc u e and In e ope abili y (Lead: UNIMAAS)
• WP4: Ope a ion o STRONG-AYA ecosys ems, S akeholde and Pa ien in ol emen , Dissemina ion,
Exploi a ion, Communica ion (Lead: E.C.O.)
• WP5: Scien i ic Coo dina ion and P ojec Managemen (Lead: NKI)
1 S oneham SJ. AYA su i o ship: The nex challenge. Cance 2020; 126: 2116-2119.
STRONG-AYA – No. 101057482 – D2.4
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STRONG-AYA will enable AYA ca e and esea ch o bene i om collec ion and pooling o pa ien -
cen e ed da a and collabo a ion among all s akeholde s: pa ien s, heal hca e p o essionals, scien is s, and
policymake s. Mo e widely, he p ojec will le e age he ne wo k o in e es ed o ganisa ions and ne wo ks
es ablished unde STRONG-AYA o long- e m s eng hened p omo ion o he necessa y implemen a ion o
specialis AYA cance se ices ac oss Eu ope. This will ul ima ely b ing no el insigh s in o AYA cance ca e,
esea ch and policy, con ibu ing o he long- e m imp o emen o ou comes o people wi h AYA cance .
Deli e able in oduc ion
This deli e able is he epo o he i s mee ing (3 d No 2023) o he STRONG-AYA E hics and Regula o y
Ad iso y Boa d (ERAB). The ERAB aims o p o ide he conso ium wi h an independen iew on he e hics
and legal challenges as well as he mi iga ion ac ions planned o al eady implemen ed by he conso ium.
The ERAB is composed o ou independen expe s in e hics and/o legal aspec s. The ERAB mee s each yea
oge he wi h conso ium ep esen a i es. This epo has been app o ed by he ou independen expe s
and by he p ojec ep esen a i es who a ended he mee ing.
5 STRONG AYA E hics and Regula o y Ad iso y Boa d (ERAB) –
Repo o he second mee ing ( i ual), 4 Ma ch 2025
Pa icipan s
• ERAB membe s
o F ancesco Ta a, UK
o F ancis P. C awley, BE
o Ma hias B aun, DE
o San a Slokenbe g, SE
• Conso ium membe s
o Da ian Meacham, UNIMAAS
o Flo a Lysen, UNIMASS
o Leona d Wee, UNIMAAS
o Ma ine Jacquemin, UNIMAAS
o Simone Hanebaum, NKI
o S ephane Lejeune, EORTC
Agenda
- Discussion on he ollow-up o ERAB’ ecommenda ions.
- The use o dynamic pa ien consen in STRONG-AYA.
- The use o he Public VaLUe Assessmen TOol (PLUTO) ool in STRONG-AYA.
Key poin s o discussion
- Commen s and ques ions on he ollow-up documen epo ing eedback om pa ne s on he ERAB
ecommenda ions (mee ing No 2023).
o To make su e ha AYA pa icipan s a e well in o med abou he p ojec and hei igh s
p o ec ed.
STRONG-AYA – No. 101057482 – D2.4
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 Pa ne s con ibu ing wi h da a ha e o a i y ag eemen ha includes he
obliga ion o in o m pa icipan s and o p o ec hei igh s. In o ma ion abou he
use o he da a is a ailable om he p ojec websi e. Communica ion campaign and
s akeholde in ol emen ac i i ies will ake place.
 Was consen used as legal base and child igh conside ed? Legal base depends on
he coun y. Legi ima e in e es was used in mos o he coun y.
 The websi e was de eloped in co-c ea ion wi h pa ien s. The e will be a FAQ sec ion
on he use o he da a and alignmen wi h child igh s con en ion.
o Wha a e he accep able pu poses o using he da a con ibu ed o he p ojec ?
 Accep able pu poses a e limi ed o esea ch and educa ion. P ojec esul s including
clinical p edic ion model a e no alida ed o o he use. I is no cu en ly planned
o do such alida ion. The e will be a disclaime on he p ojec websi e.
 I was cla i ied ha he ci cula ed documen wi h eedback o ERAB is o p ojec
in e nal use only.
 Any public p ojec s a emen e.g. on he p ojec websi e should be wo ded ca e ully
o a oid con usion o con adic ion ega ding he accep able pu poses o use.
 The conso ium will no ha e he au ho i y o p e en unau ho ized use o p ojec
esul s e.g. o clinical decision. Howe e , he use o he p ojec da a will be
con olled I.e. analysis will ha e o be app o ed be o e being un in he sys em.
 We need o di e en ia e how we concei e he scope o he p ojec and how o
communica e i o pa ien s which should be ca e ully done.
 Pa ne s need o check wha is w i en on he websi e o make su e we a e no
aising un ealis ic expec a ion om pa ien s o in con adic ion wi h p ojec ules on
he use o p ojec esul s. We mus be clea , in elligible o lay people and a oid any
misma ch.
o How pa ne s de ine he di e en ypes o esea ch ques ions, and which ypes o use s can
access o he esul s o such ques ions?
 A conso ium p ocess will de ine who can ask which ype o esea ch ques ion
(simple desc ip i e analysis e sus sophis ica ed analysis), who can code he
ques ion and who can access o he esul s. The ede a ed model will in ol e
di e en le els o con ol and igh s g anula i y.
o How o discuss accep able ade-o wi h pa ien s?
 How ade-o s a e app oached in he p ojec was explained. Pa ne s asked o
pa ien s wha hey ind impo an and wha a e hei p e e ences on how o be
in o med. Pa ne s a e e iewing he li e a u e which is complemen ed wi h
consul a ions wi h pa ien s in a co-design app oach.
 Do we implemen collabo a ion be ween he di e en p ojec boa ds: scien i ic,
e hical and pa ien s? Good poin e en i he in o ma ion is ci cula ed al eady
amongs he whole conso ium bu we could make i deepe .
 Which opics could bene i om such c oss- e iliza ion? Any p ac ical/ope a ional
opic could bene i .
- Dynamic pa ien consen .
o How such concep could be implemen ed in STRONG-AYA? This is a way o use o mo e
pa icipa o y and g anula app oach as compa ed o b oad consen o seconda y use o he
da a.
o Dynamic consen allows pa ien o decide which p ojec ime span hei consen is co e ing
and o which esea ch ques ion.
o Dynamic consen will no p eplace he classical “s a ic” consen bu add a laye allowing
pa ien o decide which da a could be used o which usage and by who.
o The p ojec could p o ide he igh si ua ion in which dynamic consen could be
implemen ed.