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 – D5.5
Deli e able Repo
WP5– Scien i ic coo dina ion and p ojec managemen
Deli e able D5.5
Publica ion on he bluep in o he na ional and he pan-Eu opean STRONG AYA ecosys ems
Due da e o deli e able: 30/09/2024
Ac ual submission da e: 11/09/2025
P ojec : STRONG-AYA
Lead Con ibu o Dan S a k, Leona d Wee
Email [email p o ec ed]; leona d.wee@maas o.nl
O he Con ibu o s Oana Lindne , Simone Hanebaum, Nicola Hughes, U ska Kosi , Wine e Van
De G aa , Olga Husson
Emails o.c.lindne @leeds.ac.uk; [email p o ec ed]; [email p o ec ed];
u ska.kosi [email protected]; [email p o ec ed]; o.hus[email p o ec ed]
Due da e
30 09 2024
Deli e y da e
11 09 2025
Deli e able ype
R
Dissemina ion le el PU
Desc ip ion o Wo k Ve sion Da e
V1.0 11/09/2025
STRONG-AYA – No. 101057482 – D5.5
Desc ip ion:
Scien i ic pape
Publishable summa y (max ½ page)
The STRONG-AYA conso ium is add essing he challenge o using eal wo ld da a o unde s and he clinical
and pa ien -cen ed ou comes ha a e speci ic o cance diagnosed aged 15-39. We will use his da a o
imp o e ca e, policy, and ul ima ely he ou comes hemsel es. A ha monised 'Co e Ou come Se ’ is ag eed,
o de ine wha should be measu ed. We a e building a se ies o AYA cance da a ecosys ems, a local, na ional
and in e na ional le els, ha will use ede a ed lea ning me hods o p o ide p e-speci ied analyses in eal
ime, based upon undamen al e hical, scien i ic and echnological p inciples. He e we desc ibe he p oblem
being add essed. Then, o o he s in e es ed in AYA cance o unde s and and join ou ini ia i e, we desc ibe:
- The de ini ions and decisions we ha e made.
- The s uc u e and componen s o ou ecosys em
- The con ex o ou ecosys em alongside simila o he s, and ou app oaches o challenges we ace
STRONG-AYA – No. 101057482 – D5.5
1 Table o Con en s
PUBLISHABLE SUMMARY (MAX ½ PAGE) .................................................................................................................. 3
1 TABLE OF CONTENTS ....................................................................................................................................... 4
2 DEFINITIONS .................................................................................................................................................... 6
3 ABBREVIATIONS .............................................................................................................................................. 7
4 DELIVERABLE INTRODUCTION/CONTEXT .......................................................................................................... 8
DELIVERABLE INTRODUCTION .................................................................................................................................... 8
5 INTRODUCTION ............................................................................................................................................... 8
AYAS SPECIFIC CANCER CARE NEEDS ........................................................................................................................... 8
THE REQUIREMENT FOR AYA-SPECIFIC CANCER OUTCOMES DATA .................................................................................... 9
THE STRONG AYA INITIATIVE ............................................................................................................................... 10
DEFINITION OF A DATA ECOSYSTEM IN CANCER CARE .................................................................................................... 10
6 DATA ECOSYSTEMS WITHIN STRONG-AYA (TABLE 1) ...................................................................................... 11
LOCAL STRUCTURES .............................................................................................................................................. 11
PARTLY NATIONAL STRUCTURES ............................................................................................................................... 11
NATIONAL STRUCTURES ......................................................................................................................................... 12
INTERNATIONAL STRUCTURES .................................................................................................................................. 12
7 GOVERNANCE MODEL, FOR THE STRONG-AYA DATA ECOSYSTEM .................................................................. 15
THE FOUNDING INTERPERSONAL AND ETHICAL PRINCIPLES OF THE STRONG-AYA DATA ECOSYSTEM .................................... 15
7.1.1 E hical, alue-based heal hca e .................................................................................................................. 16
7.1.2 Inclusi e and ocused on pa ien bene i .................................................................................................... 16
7.1.3 Open and anspa en science .................................................................................................................... 17
GOVERNANCE IN STRONG-AYA ............................................................................................................................ 18
7.2.1 De ini ion o ede a ed lea ning .................................................................................................................. 19
7.2.2 Legal go e nance suppo ing ede a ed da a ecosys ems ......................................................................... 20
PERSONNEL IN STRONG-AYA ............................................................................................................................... 21
DATA ANALYTICS TECHNOLOGY AND TECHNICAL STANDARDS IN STRONG-AYA ................................................................ 21
7.4.1 Au onomy o local and na ional da a collec ion s uc u es ........................................................................ 22
7.4.2 Technical implemen a ion o da a ‘s a ions’ .............................................................................................. 22
7.4.3 S a is ical compu ing code as s andalone ‘ ains’ ...................................................................................... 23
7.4.4 Da a analy ics dashboa ds .......................................................................................................................... 23
7.4.5 P i acy enhancemen s in STRONG-AYA ...................................................................................................... 24
7.4.6 Challenges encoun e ed in he ede a ed analy ics app oach .................................................................... 24
8 WHAT CAN WE LEARN FROM SIMILAR INITIATIVES? ...................................................................................... 25
9 KEY CHALLENGES FACING THE STRONG AYA CONSORTIUM AND OTHER DATA ECOSYSTEMS .......................... 26
SCALABLE, SUSTAINABLE, AND INTEROPERABLE ........................................................................................................... 26
MANAGEMENT OF NATIONAL AND INTERNATIONAL DIFFERENCES, OVER TIME ................................................................... 26
MANAGEMENT OF WIDER STAKEHOLDER ACCESS – WITHIN AND OUTSIDE OF THE CONSORTIUM ........................................... 28
ENGAGEMENT AND ‘BUY IN’ ................................................................................................................................... 29
STRONG-AYA – No. 101057482 – D5.5
9.4.1 Technological buy-in .................................................................................................................... 29
9.4.2 Da a hesi ancy (pa ien s, go e nmen s, IP and academic poli ics, egis y edundancy ea s, e c) ........... 30
RESOURCES (DIGITAL, FINANCIAL, PERSONNEL, EXPERTISE ETC.) ..................................................................................... 31
LONGEVITY/SUSTAINABILITY ................................................................................................................................... 32
10 FUTURE ACTIONS AND CONSIDERATIONS ...................................................................................................... 32
11 REFERENCES .................................................................................................................................................. 33

STRONG-AYA – No. 101057482 – D5.5
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 – D5.5
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
STRONG-AYA – No. 101057482 – D5.5
4 Deli e able In oduc ion/con ex
Deli e able in oduc ion
The ollowing deli e able is he manusc ip o he ecosys em bluep in o STRONG AYA. I will be submi ed
o publica ion in a sho e leng h bu we wished o p ese e i s de ail and ull leng h ia his deli e able.
5 In oduc ion
In e na ional heal hca e sys ems aim o p o ide high-quali y ca e and imp o e pa ien ou comes, anging
om clinical pa ame e s o symp oms and op imized quali y o li e. Achie ing hese goals elies hea ily on
he accu a e eco ding, moni o ing, and e alua ion o heal hca e quali y indica o s (such as clinical
e ec i eness, pa ien sa e y, pa ien -cen ed and pa ien - epo ed ou comes - 'PROs'). This da a inc easingly
a ises om eal-wo ld da a (RWD) collec ion and is hen u ilised wi hin ‘lea ning heal hca e sys ems’ as he
e idence base o ca e ans o ma ion.
Cance in Adolescen s and Young Adul s (AYAs) a e ei he a e cance ypes, such as sa comas, lymphomas,
and ge m cell malignancies, o uncommon p esen a ions o common cance s e.g. ea ly-onse ca cinomas.
The e o e, gene a ing p ac ice-changing e idence suppo ed by high quali y da a is pa icula ly challenging.
This challenge is exace ba ed because indica o s o ca e quali y and PROs ha e been (up o now) collec ed
spo adically, o non-sys ema ically, and he mos impo an ou comes o measu e a e lacking a consensus.
This makes i ha de o p io i ize and implemen he igh heal hca e imp o emen s o he AYA cance
popula ion om a s ong e idence base.
AYAs speci ic cance ca e needs
In ou scope, we selec ed he exis ing Eu opean gold s anda d, de ining AYAs wi h cance as people ecei ing
a cance diagnosis be ween 15 and 39 yea s o age inclusi e. Fi s ( o he indi iduals wi h cance ) he e a e
he challenges o AYA ecei ing op imal cance diagnosis, ea men and ca e. Wo ldwide, an es ima ed 1.2
million AYAs 1 we e diagnosed wi h cance in 2020, ep esen ing a ound 5% o all cance diagnoses 2. The
incidence o AYA cance is inc easing o e ime 3. AYA-speci ic diagnosis and ea men has ecen ly
imp o ed, since his pa ien g oup became a ocus o speci ic ocus and esea ch. All-cause and cance -
ela ed mo ali y has allen in high-income coun ies 4, so he e o e 85% o AYAs wi h cance will su i e ≥5
yea s 5,6 and some will li e >50 yea s beyond hei ea men 7.
I hey ecei e he mos e ec i e cance ca e (which should be hei s by igh ) hen he indi idual AYAs wi h
cance join a apidly g owing coho o cance su i o s who will spend he emainde o hei li es wi h
inc eased isks o physical, psychological, and social e ec s; ca dio ascula disease, seconda y malignancies,
in e ili y, inancial oxici y, and p ema u e mo ali y 8-10. These la e e ec s a e also long ecognised as
speci ic o he AYA age ange 11.
Un il ecen ly, ac oss many coun ies, heal hca e p o essionals (HCP), policy-make s and o he s akeholde s
possessed limi ed knowledge abou his popula ion's speci ic needs 12. Sadly, cance in AYAs is o en
diagnosed, ea ed and ca ed o by ei he paedia ic (<15-18 yea s) o adul (>16) ca e specialis s, when in
ac AYAs a e liminal o bo h hose se ices (ca ing mainly o pa ien s aged unde 12 o o e 70 espec i ely)
and a e a dis inc g oup, wi h a speci ic se o p io i y challenges in clinical p ac ice, equi ing a speci ic ocus
o add ess 1, 2, 13-15. AYAs’ challenges pe ain o hei :
STRONG-AYA – No. 101057482 – D5.5
(1) Unique epidemiology - AYAs de elop bo h paedia ic- and adul - ype umou s, equi ing
expe ise om bo h clinical se ices 16.
(2) Dis inc umou biology - cance s in AYAs o en exhibi age-speci ic he apeu ically signi ican molecula
ea u es and pha macological esponses, compa ed o younge child en o olde adul s wi h supe icially
simila si ua ions16.
(3) Delayed diagnosis - a lack o awa eness abou cance in AYAs and silos in se ices con ibu e o
diagnos ic delays and he e o e poo e ou comes 17,18.
(4) Limi ed access o clinical ials - AYAs pa icipa e in clinical ials a lowe a es due o una ailabili y o
ailo ed ea men s and ial designs ha do no mee hei speci ic needs, esul ing in slow imp o emen
in ou comes 19.
(5) Pe sonal De elopmen - AYAs a e unde going li e ansi ions (e.g. iden i y o ma ion, au onomy, and
ca ee de elopmen ) which in e sec wi h hei cance , making bo h heal hy de elopmen and bes cance
ea men mo e di icul o achie e 13,20.
(6) Su i al a e dispa i ies - su i al imp o emen s o AYAs lagged behind hose seen in o he age g oups
due o he ac o s abo e, unless sys emic gaps in ca e and esea ch a e add essed 21.
The equi emen o AYA-speci ic cance ou comes da a
In se ices whe e hey a e liminal, AYAs wi h cance s uggle o ind ca e ha manages hei cance in keeping
wi h hei age 22. Thei unique suppo needs a e o en no adequa ely me by cen alised paedia ic se ices
(and “ amily-cen ed” eams) no dispe sed adul oncology se ices (and “disease-cen ed” eams) 14,23,24.
Recen ly, AYA cance se ices in some pa s o he wo ld ha e been accep ed as a speci ic dis inc pa o a
comple e cance se ice, and p o ided wi h AYA-speci ic cance ca e14. Main aining his ecen momen um
equi es ongoing esea ch imp o emen s, o de ine he da a equi ed o unde s and his p og ess, and o
con inue o imp o e ou comes.
In 2016, he Na ional Cance Ins i u e (NCI) AYA cance p og ess e iew g oup epo eques ed AYA
ca egi e s o pool p ocess- ela ed and ou comes da a ac oss ins i u ions and coun ies, o make la ge coho s
a ailable o esea ch 12,22. Ex ending hese ecommenda ions, he AYA Wo king G oup o he Eu opean
Socie y o Medical Oncology (ESMO) and he Eu opean Socie y o Paedia ic Oncology (SIOP Eu ope)
concluded ha inding apid solu ions o ‘speak he same language’ among AYA cance p o essionals is
essen ial o u he imp o e ou comes o AYAs. Meanwhile widesp ead geog aphic a ia ion in AYA cance
policy and ca e pe sis wi hin and be ween na ions, and equi able se ices and op imal ca e o AYAs ha e
no ye been achie ed 14.
Collec ion o all cance ou comes da a is cu en ly no s anda dized, and is implemen ed une enly ac oss
heal h se ices; some Eu opean heal h se ices ou inely eco d and moni o clinical ou comes as well as
PROs, bu many do no . Commonly-used clinical ial endpoin s (such as i e-yea o e all su i al) a e
impo an , bu hese do no e lec AYAs’ speci ic needs, and nei he do ou come measu es designed o
young child en, olde adul s, o any si e-speci ic cance ype. Whe e da a is collec ed (wi h mo e and be e
da a o be collec ed in u u e) he ask o “pooling” highly g anula pa ien da a in o la ge eposi o ies uns
in o challenges due o di e ences in esea ch go e nance s uc u es, ules o da a e-use, nuances and
in e p e a ions o pa ien p i acy p o ec ion laws. The e o e, no el app oaches o pe o m la ge-scale
s a is ical analyses ac oss mul iple dispe sed loca ions a e needed, which can ac in a complemen a y ashion
o adi ional da a cen aliza ion in o singula eposi o ies.
STRONG-AYA – No. 101057482 – D5.5
•
Da a cu a o (quali y and
a ailabili y)
Figu e 2: a b oad axonomy o po en ial oles wi hin a da a ecosys em, adap ed om S. Oli ei a, M.I.,
Ba os Lima, e al., 2019.
The alignmen o incen i es and mo i es ac oss hese oles elies on a keen unde s anding o each indi idual
and ins i u ion’s capaci y o achie e hei goals h ough he joining o a pan-Eu opean da a ecosys em. The
ongoing incen i es and mo i es o he exis ence o he STRONG-AYA Conso ium and pan-Eu opean
ecosys em a e e lec ed in he p inciples ou lined in mo e de ail u he , bu a e he e summa ized as:
1. Imp o emen in he p o ision o heal hca e se ices:
a. The de elopmen o alue-based clinical p ac ice;
b. Accele a ing he implemen a ion o eal-wo ld insigh s o imp o e clinical p ac ice.
2. Pe o ming e hical esea ch on la ge da ase s:
a. Encou aging in e na ional collabo a ion o esea ch and clinical expe ise;
b. Imp o ing and expanding upon he applica ions o a ailable da a in esea ch;
c. Unde s anding and le e aging ins i u ional capaci y.
3. Imp o ing pa ien ou comes:
a. De ining and iden i ying pa ien unme needs – in esea ch and clinical ields;
b. Imp o ing he di e si y and each o pa icipan s and bene icia ies om esea ch and pa ien
ou come measu emen ;
c. Imp o ing he u ilisa ion o eal-wo ld heal h and heal hca e da a.
We belie e i pe ec ly easonable ha di e en membe s may ha e a ange o incen i es o pa icipa ing
in he Conso ium. Ins i u ional incen i es and mo i a ions migh also go beyond di ec pa ien bene i , which
na u ally in luences he pu poses o da a analysis ha hey conduc . These may encompass disco e y (i.e.
mining inc easing olumes o da a o help manage a e diseases), o accele a ing implemen a ion o exis ing
ini ia i es (i.e. sha ing adminis a i e wo kload on di e se da ase s), o encou aging sus ainable in e na ional
collabo a ion (i.e. angible ou comes ha os e collabo a i e p ac ices).
Below we p o ide mo e de ail on he ounda ional p inciples o STRONG-AYA, which d i e he s uc u e and
unc ioning o he componen s as de ined abo e.
7.1.1 E hical, alue-based heal hca e
By b oadening he esea ch using no el p i acy-sa e app oaches owa ds da a analy ics, STRONG-AYA will
b ing no el insigh s in o AYA heal hca e, encou age e hical e-use o sca ce AYA esea ch da a, p o ide eal-
wo ld e idence o all impo an AYA oncology decision-make s, and hus, inc ease he bene i o pa ien s by
making ca e mo e e icien .
7.1.2 Inclusi e and ocused on pa ien bene i
STRONG-AYA ools and ac i i ies a e pa ien -cen ed, ollowing he e hos o ‘no hing abou me wi hou me’.
These e hical p inciples, cen ed on he in e es s, p e e ences, and alues o pa ien s, a e ounda ional o
he Conso ium, ei e a ed and e lec ed in he design, buil and main ained h ough s akeholde

STRONG-AYA – No. 101057482 – D5.5
engagemen and e lec ions by he Pa ien Ad iso y Boa d (PAB). The PAB is composed o young
people wi h li ed expe ience, composed based on Equi y Di e si y and Inclusion p inciples, ac i ely seeking
ep esen a ion ac oss a ious dimensions such as expe ise, geog aphy, and umou ype. The PAB p o ides
ongoing suppo o he STRONG-AYA ini ia i e by sha ing knowledge, acili a ing eedback wi h AYA cance
pa ien communi ies, and con ibu ing o ou each, webina s, and o he collabo a i e ac i i ies.
Impo an ly, any ools and ac ions wi hin STRONG-AYA aim o complemen and op imize ace- o- ace
heal hca e; pa ien s a e in o med o he bene i s and he limi s o ools de eloped by he Conso ium, and
can cus omize hei in e ac ions wi h hese ools. STRONG-AYA's esul ing insigh s and ools need o be
accessible, meaning pa ien s:
• can easily and eliably access/ e ie e hei own STRONG-AYA heal h da a (usually h ough hei own
hospi als’ sys ems);
• see and be e unde s and hei own heal h da a in he con ex o o he , simila , AYAs;
• easily access in o ma ion on he uses o hei heal h da a, and i s’ pu pose, such ha hey should be able
o easily enhance, g an o emo e access o hei heal h da a depending upon hei pe spec i e on each
‘case o use’ o hei da a, and exe cise his igh eely;
• will ha e a oice in designing ools de eloped by STRONG-AYA, including p omo ing he p inciples o EDI
such ha he solu ions emain accessible o all (including o example people wi h disabili ies,
neu odi e gen popula ions, o di e en le els o digi al li e acy). They should be in ui i e and easy o
use; pa ien s should ha e access o aining o help hem unde s and hese ools, which should be
implemen ed in ou ine ca e ha includes human communica ion, space and ime o addi ional
ques ions and eedback.
Hence, STRONG-AYA will no only equip AYAs wi h li ed expe ience wi h in o ma ion o op imize hei
heal hca e, bu also o e an oppo uni y o build on hei heal h li e acy, and suppo sha ed and
pe sonalized decision-making be ween AYA and heal h ca e p o ide s. This ex ends o in ol ing pa ien
g oups in he con e sa ions a ound he design, ac ions and ope a ions wi hin he ecosys em and he co-
c ea ion o he pa ien pla o m and me hods o da a isualiza ions, any design ea u es, u o ials, and e en
app op ia e wa ning o explana o y messages. ‘Meaning ul’ pa ien pa icipa ion c ea es ac ionable pa ien -
cen ed and pa ien -in o med insigh s. Co-c ea ion wi h PAB and hei ou each is expec ed o esul , ia
local/na ional-le el go e nance and e hical sys ems, in pa ien s’ iews as guiding p inciples o he
conso ium.
7.1.3 Open and anspa en science
STRONG-AYA abides by he p inciple ha he esea ch pu sued and insigh s gene a ed using he da a
(including publica ions, s a is ics, so wa e, e c.) and i s dissemina ions shall be accessible o all s akeholde s
and he gene al public. The e o e ou me hods should be anspa en and accessible, and knowledge
de eloped should be sha ed and ac ionable ac oss he ecosys em. S akeholde s commi o all algo i hms
used o da a analy ics being openly accessible and cons an ly e iewable/c i iqued. All publica ions ela ed
o STRONG-AYA will be open access unde ele an local o EU unding. Any dissemina ion ac i i ies a e
openly a ailable o membe s o he wide public as well as specialis s, ia a egis e main ained by he
STRONG-AYA P ojec Coo dina o .
While mos insigh s and p oduc s will be accessible o membe s wi hin he STRONG-AYA ecosys em, as well
as he me hods o p oduce hese, he g anula i y o which he da ase s can be accessed and wha is que ied
STRONG-AYA – No. 101057482 – D5.5
will depend on he ype o s akeholde eques ing access and hei mo i es. The e o e, while all
me hods and dissemina ions a e open access, he indi idual le el pa ien da a will no be open access,
adhe ing o da a p o ec ion, and p i acy- and con iden iali y-by-design p inciples.
Fo equi y in da a p o ision and da a que ies, and hence o educe po en ial o misalignmen esul ing om
powe asymme y, he STRONG-AYA da a ecosys em will ensu e:
• Da a owne ship and con ol will be held by local P incipal In es iga o s and hei eams.
• The ac ions he ein a e no a new opology o da a con ol exe cise by a single pa ne .
• Da a analysis mus s ill se e i s named unc ion i one pa ne conscionably op s ou o a pa icula
analysis o a speci ic use case (albei in such cases on a likely educed da a sample size).
Go e nance in STRONG-AYA
STRONG-AYA pa ne s belie e ha g ea e anspa ency abou da a owne ship, collabo a i e analysis, and
he e o e clea da a con olle ship p omo es us – among conso ium pa ne s and among s akeholde s we
dissemina e esul s o. A local and na ional le els, STRONG-AYA go e nance is inclusi e o local policy and
legal ag eemen s ac oss he na ions in ol ed. Responsibili y o adhe e o hese emains wi h he pa ne s.
P ac ically he e o e, STRONG-AYA con o ms o explici le els o da a anonymiza ion; su icien isk-guided
popula ion minimums mus be me o pe mi analysis o e-analysis, o p o ec agains unin ended e-
iden i ica ion o indi idual da a subjec s (e.g. coho s >10 as de aul , bu may be adjus ed wi h jus i ica ion).
A an in e na ional and pan-Eu opean le els, STRONG-AYA uses a sel -go e nance model which is open and
inclusi e ac oss i s ope a ions. Speci ically, ou p inciples encou age a wide communi y o expe s o join in
he p oduc ion o scien i ic insigh s, accep ing anspa ency in da a, inclusi eness, in e -ope abili y,
collabo a ion, longe i y, and sus ainabili y. STRONG-AYA’s go e nance and legal p inciples align a he pan-
Eu opean, local and na ional le els. I aligns wi h, among o he s, he Eu opean E hical P inciples o Digi al
Heal h (2022), na ional and in e na ional p i acy laws - such as he Gene al Da a P o ec ion Regula ion
(GDPR; h ps://gdp -in o.eu/), and applicable sub-legisla ions ela ing o law ulness; ai ness and
anspa ency; pu pose limi a ion; da a minimiza ion; accu acy; s o age limi a ion, in eg i y and
con iden iali y; and accoun abili y.
Wi hin his Go e nance Model STRONG-AYA acknowledges and welcomes he di e ences be ween
ins i u ions and coun ies in hei capaci y, capabili ies, and limi a ions in wha da a can o canno be used
in ou analyses. The e is an expec a ion ha no all coun ies and ins i u ions will be able o ully mee all
equi emen s all he ime (e.g. echnical, adminis a i e, legisla i e, e c.) and he e will be gaps in policies as
well as p agma ics o da a secu i y, quali y con ol, and managemen . The e hos o a collabo a i e pan-
Eu opean ecosys em is ha hese gaps will impose less limi s upon scien i ic lea ning wi hin ou da a
ecosys em. The e o e, a c ucial ask o STRONG-AYA o implemen is he anspa en communica ion and
discussion o hese po en ial di e ences and gaps, o allow oom o hei oubleshoo ing and seconda y
plans o achie e explici goals.
In he case o p ospec i e (no el) da a collec ion (such as PROs based on he COS), each local pa ne needs
o ensu e ha anspa ency is p esen in communica ion wi h pa icipan s. This means ha all pa icipan s
ha e p o ided and documen ed in o med consen . In he case o e ospec i e (his o ical) da a a ailable and
p o ided by pa ne s, a icle 4 o GDPR applies, he eby he da a collec ed by a pa ne mus mee all h ee
g ounds allowing he p ocessing o such da a. Namely; he da a can be p ocessed i a) he pa icipan o e ed
STRONG-AYA – No. 101057482 – D5.5
eely gi en, speci ic, and in o med consen (A icle 6 (1) (a)); b) p ocessing is a legi ima e in e es
excep ion such as he e is a legi ima e in e es o con olle s AND he legi ima e in e es canno easonably
be achie ed by using al e na i e means AND he in e es s and undamen al igh s and eedom o he
pa icipan do no ake p ecedence o e he legi ima e in e es s o he con olle (s); c) he da a is
anonymized and he e o e alls ou side GDPR. As an example, a legi ima e in e es excep ion would be ha
o es ing hypo heses o he pu pose o public heal h.
The Conso ium encompasses a Commi ee o Coo dina ion (C C), which was es ablished by NKI (as he
leading o ganisa ion) o o e see he pan-Eu opean ecosys em. The C C has a c i ical ole in ensu ing ou
p inciples a e adhe ed o. Comp ising leade s o local ecosys ems and pa ien ad oca es i de ines he
esponsibili ies o membe s, including he Pa ien Ad iso y Boa d, de ines and implemen s c i e ia o newly
joining membe s, encou ages adhe ence o ounding p inciples and communica ion among na ional
ecosys ems. I also ensu es consis ency, s anda diza ion and ha moniza ion o da a and p omo es scalabili y
o and wi hin coun ies o gua an ee he sus ainabili y and longe i y o he ne wo k o ecosys ems.
The C C as pa o a de ined o ganisa ional s uc u e, has he esponsibili y o de ine and manage p ocesses
ela ed o:
• exis ing membe ac ions, esponsibili ies, and igh s;
• new membe access applica ions and ules o using o he da a ecosys em;
• aligning he accep able mo i es and incen i es o accessing and using he ecosys em;
• de ining and en o cing ules ela ed o he submission o new use cases, u ilising he exis ing ones
and que ies ha can be un on he da a ha al eady exis s in he ecosys em;
• ensu ing all membe s ac i ely con ibu e and abide o he equi ed s anda ds;
• esol ing po en ial dispu es and ambiguous si ua ions;
• sha ing success, e.g. in ellec ual p ope y om he use o he da a ecosys em.
As de ined in ou ecosys em goals (sec ion 1.4), we ha e op ed o a ede a ed da a ecosys em which
p ese es se e al e hical and go e nance objec i es, wi hou penalizing a ela i ely apid pace o ‘lea ning’
(da a analy ics) ha could be pe o med. I is impo an o cla i y wha is mean by ‘ ede a ion’ he e.
7.2.1 De ini ion o ede a ed lea ning
‘Fede a ed lea ning’ e e s o a g oup o compu a ional me hodologies whe e esea ch ques ions o esea ch
p oblems (‘use cases’) ha can be add essed ma hema ically and coope a i ely, bu wi hou exchanging
iden i iable human subjec -le el da a be ween any o he coope a ing ins i u ions
(h ps:// heodi.o g/insigh s/explaine s/wha -is- ede a ed-lea ning/). Ou meaning o ede a ion is NEITHER
a cloud-based NOR a physically-loca ed mas e da a loca ion, o which all pa ne s mus cen alize hei
subjec -le el da a o he ‘owne ’ o ha mas e eposi o y on behal o he conso ium.
In con as , ou concep o ede a ion emb aces ully decen alized digi al da a eposi o ies – wo o mo e o
such eposi o ies, ideally loca ed inside each ca e-gi ing ins i u ion’s zone o con ol (whe e he indi idual-
le el heal hca e da a was collec ed in he i s place e.g. a hospi al). In such as opology, he desc ip i e
s a is ics and epidemiological ma hema ical modelling mus necessa ily be pe o med on mul iple local
compu ing de ices, co-loca ed wi hin each da a eposi o y, on he sample size (e.g. > 10 cases pe a iable)
ha is con ained inside each ins i u ion.
STRONG-AYA – No. 101057482 – D5.5
Finally, he pa ial ma hema ical esul s (bu mos impo an ly NOT he subjec -le el da a) om each
ins i u ion a e b ough oge he on an enc yp ed elecommunica ions ne wo k, o gene a e he mul i-
ins i u ional o e all ‘ esul ’. Fo epidemiological models, his gene ally equi es i e a i e and s epwise
nume ical in eg a ion o esul s, which con e ge on he ma hema ical ‘answe ’. Technical de ails on he
implemen a ion will be p o ided in Sec ion 3.5 la e .
The implemen a ion o STRONG-AYA as a ede a ed da a ecosys em enables collabo a i e lea ning, and
he e o e aligns na u ally wi h he ollowing pan-Eu opean conso ium aspi a ions:
• Da a Au onomy – ou ede a ion app oach allows local and na ional ecosys ems o emain ully in
con ol o hei da a a all imes, and no one ou side o he ins i u ion can see hei espec i e
indi idual-le el da a, while a he same ime coope a i e o e all insigh s and collec i e answe ing o
esea ch ques ions emains ully suppo ed.
• Da a Solida i y – ou AYA subjec s al uis ically ga e consen o use hei pe sonal da a o imp o e
heal hca e, bu hey do no wan any nega i e epe cussions o ace back o hem leading o
emba assmen , s igma iza ion, su eillance by au ho i ies, o iola ion o p i acy. By no exchanging
any pa ien -le el da a, only s a is ical compu a ions on mul iple coho s, his makes i ex emely
di icul o a malicious ac o – ei he inside he conso ium o ou side – o e-iden i y any da a
subjec e en i he e we e success ully able o b eak he indus y-g ade elecommunica ions
enc yp ion.
• Open Science – since decen alized compu a ions a e no physically pe o med by human eyes and
hands, i is necessa y o p o ocolize and p e-speci y he s a is ical analyses a p io i, which includes
he selec ion o coho s and he endpoin s be o e analyses. E e y da a analysis needs o be explici ly
w i en co-ope a i ely among pa ne s, as compu e code which will be open access, pe manen ly
audi able and necessa ily ep oducible on public so wa e eposi o ies (such as Gi Hub) e en hough
he pa ien da a emains sec e .
• Di e si y and Inclusi i y – clinical and heal h ca e esea ch bene i om lea ning as much as possible
om he he e ogenei y ha is p esen in he eal wo ld. I is only by compa ing and unde s anding
di e ences in ou comes ha he STRONG-AYA ecosys em and communi y imp o e he
unde s anding he de e minan s o op imal alue-based AYA cance ca e. The abili y o lea n om
sensi i e pe sonal da a, wi hou be aying he da a subjec s who ha e olun ee ed hei da a, helps
us o add ess impac s o sample size, di e si y and inclusi i y when dealing wi h liminal heal h
esea ch subjec s such as AYAs wi h cance .
In STRONG-AYA, no ex e nal pe sons a e gi en any access o in o ma ion abou AYAs wi hin local ins i u ional
eposi o ies. Since pa ien da a s ays locally whe e hey a e ini ially gene a ed, his acili a es op -ou o
some ypes o analyses and enhanced op -in o ce ain o he analyses, p o ided ha pa ien engagemen
and he COS-guided da a collec ion can suppo his le el o de ailed ongoing engagemen , wi hou equi ing
modi ica ion o a cen alised da abase.
7.2.2 Legal go e nance suppo ing ede a ed da a ecosys ems
A ede a ed da a ecosys em he e o e equi es, a minimum, a numbe o explici ag eemen s ha es ablish:
1) he communi y o ins i u ions and acknowledgemen o hei supplemen a y go e nance p ocedu es – his
is commonly known as a ‘Collabo a i e Resea ch’ o equi alen ly ‘Conso ium’ ag eemen . 2) Da a p o ec ion
impac assessmen s (DPIAs) ha a e esonan wi h in e wea ing o he local, na ional and in e na ional
s uc u al equi emen s. 3) A da a access amewo k ag eemen ha de ines he p inciples o da a
con olle ship and pe missible pu poses o coope a i e da a p ocessing in con ex o a ede a ed
STRONG-AYA – No. 101057482 – D5.5
elecommunica ions sys em. 4) In as uc u e se ice ag eemen (s) wi h disin e es ed echnology
se ice p o ide (s) ha a e able o hos he echnical and compu a ional componen s, bu do no ha e any
say wha soe e abou esea ch ques ions, o pa ien da a o knowledge ha a ise due o conso ium
ac i i ies.
An example o ag eemen empla es om p e ious ede a ed lea ning p ojec s, ha ha e been used o
de elop he STRONG-AYA legal ag eemen s, may be ound openly accessible he e:
(h ps://www.medicalda awo ks.nl/go e nance). In due cou se, he ( edac ed) STRONG AYA se o
documen a ions will also be openly a ailable he e (www.s ongaya.eu) as a empla e o u u e p ojec s.
Pe sonnel in STRONG-AYA
Local/na ional ecosys ems consis o people wi h li ed expe ience o AYA-onse cance , pe sonnel om
mul iple heal hca e disciplines, including clinicians, allied heal h p o essionals, epidemiologis s and
indi iduals wi h da a science skills. Each cen e has i s own esponsible p ojec and da a manage s. These,
wi h he P incipal In es iga o s, o m he ope a ional g oups co-o dina ing ou local and pa ly na ional
ecosys ems. PPIE g oups, cha i ies and policy make s a e in eg al o success, so each cen e has clea plans
and oadmaps o se ice use s akeholde engagemen , as well as communica ion abou he p ojec wi h
wide local heal hca e p o essionals. We expec his o expand as o he s akeholde s, whose e hical
p inciples align o hose o STRONG-AYA, join ou ini ia i e.
Da a analy ics echnology and echnical s anda ds in STRONG-AYA
In his sec ion, we explo e he echnical nuances in mo e de ail, speci ically he key enabling echnologies
ha makes a ede a ed da a ecosys em usable.
Fede a ed lea ning (‘FL’) is an es ablished and apidly ma u ing me hodology ha ing uniquely high alue in
pan-Eu opean p ojec s, especially when dealing wi h sensi i e pe sonal heal h da a. The legally-binding
implemen a ion o he Eu opean Heal h Da a Spaces (EHDS) ollows a long adi ion o ede a ion p ojec s in
Eu ope, ha ely on no el p i acy-enhancing echnologies – o example, secu e mul i-pa y compu a ion,
di e en ial p i acy and ede a ed lea ning – as a means o enhancing mul i-ins i u ional and global
coope a ion, while p o ec ing he igh s and con iden iali y o da a subjec s. Eu opean-le el p ojec s o
simila scale and cons uc ion as STRONG AYA include: (i) Fea u eCloud, which uses enc yp ion and
blockchain-based compu a ions o p o ec indi idual iden i y. (ii) TRUMPET, which collec i ely lea ns om
mul i-si e adia ion dosime y da a in o de o pe sonalize adio he apy ea men . (iii) AI4EOSC, which will
p o ide compu a ionally in ensi e ede a ed A i icial In elligence o esea che s in he Eu opean Open
Science Cloud. (i ) DIGIONE, which pionee s an EU-wide apidly lea ning oncology sys em aiming o op imize
ea men selec ion o cance pa ien s.
We ha e highligh ed abo e he oles o local ins i u ions, na ional bodies and in e na ional conso ia in he
o ma ion o a ede a ed da a ecosys em. To connec hese wi h an easily isualizable echnology, we may
conside : (i) he local ins i u ional and na ional da a eposi o ies as s and-alone ‘s a ions’. (ii) ins ead o
mo ing pe sonal pa ien da a a ound, we will ins ead send ou compu e code ha can pe o m s a is ical
compu a ions on ou behal , i.e. ‘ ains’. (ii) while he da a is inhe en ly p o ec ed by i s own da a s a ions,
he in eg i y o he elecommunica ions connec i i y be ween s a ions mus be kep p i a e o he
conso ium, and sa egua ded agains malicious ac o s ying o ‘ea esd op’ on he s a is ical esul s o in

STRONG-AYA – No. 101057482 – D5.5
some way a emp o e-iden i y one o he da a subjec s. Such p o ec ions had o be wo en in o
he digi al and ope a ional in as uc u e o he ecosys em, which we would call ‘ acks’. This gi es us he
easily accessible analogy o p o ocolized ‘ ains’ a elling ou wa ds o p i a ely held da a ‘s a ions’ o do
s a is ical analysis, hen b inging oge he he coho -based analysis esul s (no indi idual da a) using
cybe secu i y-assu ed ‘ acks’, i.e. an implemen a ion o he “Pe sonal Heal h T ain” pa adigm
(h ps://www.d ls.nl/ ai -da a/pe sonal-heal h- ain/).
7.4.1 Au onomy o local and na ional da a collec ion s uc u es
Whe e local sys ems al eady collec Pa ien - epo ed ou come o Pa ien - epo ed expe ience da a, his is
u ilised o STRONG-AYA da a collec ion, and whe e he e a e no such local sys ems he expe ise in he
conso ium suppo s i s implemen a ion. Tha is, each pa icipa ing ins i u ion e ains ull con ol o i s da a
eposi o y, i s da a acquisi ion esou ces and i s own da a managemen policies, using inso a as possible he
echnical capabili ies i has buil up p io o o ming STRONG-AYA. Howe e , o suppo sys ema ic and
in e na ionally ha monized collec ion o AYA da a, he Conso ium has now published and deployed he ‘COS’
o use a he local and na ional le els.
7.4.2 Technical implemen a ion o da a ‘s a ions’
Whils local and na ional ac o s ully con ol and en i ely own hei espec i e da a, some in e media ion
echnologies a e equi ed by each conso ium pa ne o make his da a simul aneously p i a e ye also
a ailable o collabo a i e lea ning. The e o e STRONG-AYA de elops, ex ends and deploys o all pa ne s a
se o ee, open sou ce and publicly accessible so wa e ools o b idging ins i u ional da a o ma s wi h he
conso ium COS, despi e he ange o local and na ional sys ems 32.
In STRONG-AYA, we adhe e o he Findable-Accessible-In e ope able-Reusable (‘FAIR’) da a managemen
p inciples 33. This s a es wo key p inciples ha mus be emphasized : (i) FAIR da a does NOT imply ha da a
is openly accessible, and (ii) ha FAIR-ness cons i u es da a which is sui able – by way o ‘me ada a’
anno a ions desc ibing he ac ual da a - ha makes i possible o bo h humans (manually) and compu e
code ( emo ely) o in e ac wi h he da a. Addi ionally, he FAIR p inciples s a es ha no one single o ma
o s uc u e necessa ily akes p ecedence o e any o he . Fo example, he OMOP Common Da a Model
(‘CDM’) is popula in many coun ies, bu STRONG-AYA does no exclude any membe ’s da a solely on he
basis ha i did no con o m o one ‘CDM’. We include a plu ali y o da a sys ems, s uc u es and o ma s,
al eady in use in local and na ional sys ems, some mo e and some less in e ope able wi h each o he . The
key ad an age o a ‘me ada a o e lay’ ype o me hodology is ha , as a conso ium, we will s i e o a
s anda diza ion o an op imum minimal le el o da a, and we can ha monize/in e -calib a e he es , hus
aiming a syn ac ic and seman ic in e ope abili y ha will ma u e in pa allel wi h he Conso ium.
Whene e he Conso ium needs o enhance he COS o upda e he de ini ions, i is only necessa y o e ise
he me ada a, no he ac ual pa ien da a i sel . Finally, mul iple code dic iona ies co-exis wi hin he
me ada a, so he me ada a implemen s he ha moniza ion ac oss e minologies and measu emen scales,
and i is no necessa y o e ise o e-code he aw da a, o ‘ o ce’ equi alencies, a e i is collec ed.
Fede a ion also suppo s decen alized s a is ical model ‘ aining’ (e.g., eg ession, neu al ne wo ks) wi hou
comp omising da a p i acy and adhe ing o da a minimiza ion h esholds.
STRONG-AYA – No. 101057482 – D5.5
7.4.3 S a is ical compu ing code as s andalone ‘ ains’
All code o use by he Conso ium is placed in a publicly eadable eposi o y, such ha any pe son can openly
examine he code and inspec i o po en ial ulne abili ies, and local da a expe s a e equi ed p agma ically
o e iew ha code as i is c ea ed. Fo conso ium wo k, echnology pa ne s a e included, and
independen ly c oss- e i y ha he code pe o ms he ma hema ical unc ion co ec ly, and does no con ain
any malicious ac ion, be o e he speci ic e sion o he code in he eposi o y is locked o use wi hin he
conso ium. Only locked code is packaged in o s andalone, independen , and ope a ing-sys em agnos ic
so wa e applica ions (i.e., Docke ® con aine s) which we e e o as ‘ ains’. The ain hus encode he
s a is ical analysis eques ed and desi ed by he Conso ium pa ne s ac ing join ly, o example, one ain
may con ain a gene alized eg ession model, o ano he ain may ha e code o s a is ically summa ized
p e alence o di e en cance ypes.
Thus de elopmen o he ains goes hand in hand wi h: (i) he speci ic use cases exp essed by he
Conso ium, (ii) he ag eemen in ad ance o he Conso ium abou which da a ields and wha analysis needs
o be pe o med, and (iii) how he inal esul s o he compu a ional ac ions a e o be made a ailable, and o
whom.
7.4.4 Da a analy ics dashboa ds
The s a is ical esul s and epidemiological models coming om he STRONG-AYA da a collec ions needs o
be p esen ed in a cogni i ely accessible way, o be dissemina ed o champions who can hen implemen
ans o ma ion o AYA ca e in hei local and na ional ecosys ems. We ake his o mean ‘dashboa ds’ (i.e.
use - iendly da a isualiza ion web-b owse based applica ions). These p esen he esul s o , o insigh s
om, analyses comple ed upon he conso ium da a ei he on a scheduled ( ime-based), ad hoc (e.g. a
speci ic one-o clinical hypo hesis es ) o on-demand (e.g. a use wishes o see a gene alized coho
summa y o PROs alues ac oss b oad ange o cance ypes immedia ely, o good eason).
The e o e, co-design and co-c ea ion – meaning clinicians, esea che s, AYAs and policy make s as a cohesi e
whole – is undamen al o he way we epo ou esul s. The unde lying echnology is in ended o be in isible
and unob usi e whe e possible, while he use ocusses on gaining insigh , communica ing knowledge and
applying igu es/g aphs c ea ed. The aim is o in eg a e AYA-speci ic aspec s in o, o example, esea ch
ques ions ( om Eu oCa e enqui ies), pa ien -d i en ques ions ( om AYA discussion o a) and o policy
d a ing (such as by ECO). The objec i e he e is o make da a insigh s, such as he COS acc ued by ou
Conso ium, accessible in a speci ic ime- ame including ‘in eal ime’, and wi h g anula i y be i ing he use
and he ques ion.
The choice o web-b owse based applica ion as a design p inciple is in o med by he need o pa ly decouple
he communica ion/dissemina ion aspec s, which equi e capabili ies in web design and isual use
in e ac ion, om he unde lying in as uc u e echnology which handles he p i acy, access con ols,
ne wo k cybe secu i y and elecommunica ions p o ocols. The o me is join ly a wo k in p og ess wi h
conso ium pa ne s including YCE; he la e has been con ac ed in la ge pa o a Medical Da a Wo ks B.V.
ha has speci ic expe ise in Van age6 open-sou ce ede a ed in as uc u e.
STRONG-AYA – No. 101057482 – D5.5
7.4.5 P i acy enhancemen s in STRONG-AYA
A ede a ed app oach o AYA-onse cance needs o add ess he challenges o co-o dina ed wo king wi h
small case numbe s and ye p o ide imely, iche and mo e obus insigh s in o ca e o ea men compa ed
o single da abase o o mal da a ans e me hods.
In STRONG-AYA ou g ea es sha ed esponsibili y is da a secu i y. This begins i s a he local ecosys em
le el, whe e he de ailed da ase s a e collec ed and s o ed. A all le els ac oss STRONG-AYA, access and
con ol p o ocols ha e been de e mined and de eloped o block ce ain in o ma ion eaching speci ic
s akeholde s. Fo example (in u u e) a pha maceu ical o medical de ices comme cial pa ne may no be
pe mi ed o de elop analyses in ol ing speci ic d ugs adminis e ed o special p ocedu es ca ied ou ;
howe e such in o ma ion migh be made accessible o clinicians and esea che s who wish o de elop
p edic ion models. Well-de eloped access managemen om local le els shall unde pin coope a ion a an
in e na ional le el o suppo he bene icial use o he conso ium in as uc u e. The p i acy enhancemen
in ede a ed lea ning is unde pinned by he un easibili y o e e se-enginee ing a pa icula pa icipan s’
iden i y om summa ies, s a is ical models o o he such combined analysis esul s based on g oups o
pa icipan s ( ypically p esen ed in epo s and publica ions).
Second, ou da a secu i y mus conside s a is ical analyses equi ing equencies o ou comes o answe
esea ch ques ions – such as he numbe s o pe sons ‘ali e (o deceased)’, ‘diagnosis posi i e (o nega i e)
o a ime in e al (such as ’90 days since a ce ain e en ’). In special ypes o esea ch ques ions, he e is a
isk ha such an ou come may be cha ac e is ic o only one o a ew pa ien s – in which case he desc ip i e
s a is ics o epidemiological model may no longe obscu e he da a alues o indi idual subjec s. OU
in as uc u e is designed o block analyses ha do no ha e su icien coho size. By de aul , as s a ed
ea lie , his numbe is a bi a ily se a 10, howe e ins i u ions in ce ain use cases may ha e jus i ica ion o
inc ease o educe his numbe , on a case-by-case isk-guided basis.
Finally, he de elopmen o he COS i sel is based on he idea o da a minimiza ion, e en hough no pe son-
le el da a is being sha ed. S uc u ed in o ma ion om he ins i u ional collec ion o he COS da a ields will
be ex ac ed by in es iga o s wi hin each ins i u ion, hen popula ed in o hei espec i e STRONG-AYA da a
‘s a ions’ con olled by hei own ins i u ion and go e ned by hei own da a p o ec ion egula ions. All da a
placed in hese a eas will be checked o ensu e i is pseudonymized o anonymized (as consis en wi h he
DPIA and da a access ag eemen s) o a oid he e-iden i ica ion o indi iduals, and o emain complian wi h
GDPR and local egula ions. Fu he , po en ially aceable iden i iable in o ma ion which a e no necessa y
o conso ium analyses - such as bi h da es and pos codes – a e emo ed a e ex ac ion, and all absolu e
da es o clinical e en s will be eplaced by ime in e als, say numbe o days om diagnosis ill ecu ence
o cance , o example.
7.4.6 Challenges encoun e ed in he ede a ed analy ics app oach
While ede a ed lea ning comes wi h ce ain a endan ad an ages in e ms o da a access and anspa en
analy ics, he e a e addi ional conside a ions ha mus be acknowledged. Fede a ed ecosys ems may be
able o p ocess dispa a e, la ge, and complex da ase s, o accele a e indings in a speci ic heal h ield and
he eby inc ease esea ch powe , de ail, and each. The ede a ed da a ecosys em concep acknowledges
and espec s ha da a collec ion wo k lows and da a managemen p ac ices will be speci ic locally, and
al eady in use ex ensi ely among local p ojec pa ne s o nume ous ope a ional and esea ch pu poses.
Da ase s owned by p ojec pa ne s will be e-used o he uni a y common goal o answe ing p e-de ined
clinical esea ch ques ions, h ough ini ial p io i y esea ch ques ions.
STRONG-AYA – No. 101057482 – D5.5
Howe e , his au onomy and con ol o e da a a he local and na ional le els will also in oduce pe sonnel,
expe ise and esou ce alloca ion ques ions o he ins i u ions ha pa icipa e in he ede a ed da a
ecosys em. In cen alized designs, he pa ne s may – i hey wish – ake a less ac i e ole by sending da a o
he p incipal in es iga o , he eby elying on compu ing esou ces, da a cleaning, domain expe ise and
analysis skills a ailable a he leading ins i u ion. The ede a ed app oach wa an s ha he skills and
expe ise a e mo e dispe sed among he pa ne s, a he han being concen a ed in one. The e is he e o e
a s ong and signi ican case o conso ium-wide echnical suppo , knowledge sha ing, and deploymen o
cus omizable so wa e ools o acili a e wo king in a ede a ed ashion.
Addi ionally, he e needs o be a undamen al willingness om he lead ins i u ion o sha e i s expe ise and
suppo he ma u a ion o esea ch capaci y (along wi h i s a endan esou ces) mo e widely a ound he
conso ium, a he han keeping hese in one loca ion.
8 Wha can we lea n om simila ini ia i es?
The Heal h Ou comes Obse a o y (H2O) p ojec is a public-p i a e pa ne ship unded by he Eu opean
Union. I aims o build an in e na ional ecosys em o inco po a e heal h ou comes, including pa ien -
epo ed ou comes in heal hca e decision making ac oss h ee diseases: diabe es, cance and in lamma o y
bowel disease. The e a e se e al simila i ies wi h STRONG AYA. Bo h p ojec s a e in e es ed in ou come se s,
pa icula ly pa ien - epo ed ones, and bo h use a ede a ed da a in as uc u e and seek o use digi al ools
o in ol e pa ien s in he da a sha ing pa hway. They di e in e minology; H20 has a ou ed he e m
‘obse a o ies’ o desc ibe i s da a in as uc u e whe eas we use he e m ‘ecosys em’ and hey a y in hei
go e nance s uc u e. H20 has op ed o c ea e sepa a e non- o -p o i legal en i ies, co-led by a public and
p i a e en e p ise ep esen a i e in each coun y. These en i ies a e cu en ly ope a ional in h ee o he
ou coun ies in ol ed in he p ojec : Aus ia, Spain and he Ne he lands (Ge many has no ye been se up
acco ding o public esou ces). A e iew o hei websi e (h ps://heal h-ou comes-obse a o y.eu/) sugges s
ha his legal en i y ou e may allow o u he g an acquisi ion la e as hey would be new en i ies applying
o unding, bu ha a conside able amoun o ime and esou ces we e alloca ed wi hin he p ojec o he
bu eauc acy o c ea e hese en i ies. Taking hese s eps a an ea ly s age po en ially limi s buy-in om o he
pa ies as easibili y has no ye been p o en and buy-in is based on he p emise a he han he ac ual
unc ion. Fu he mo e, he na ional obse a o ies may be na ional in hei legal egis a ion bu ace he
challenge o p oduce na ionwide da a i hey canno on boa d mul iple cen es, da a sou ces, o na ion-wide
s udies in each coun y. The Du ch na ional obse a o y s ill only includes he E asmus Uni e si y Medical
Cen e as a sou ce o da a, and simila ly only one medical cen e is in ol ed in Spain and in Aus ia and
Ge many, whe e one cen e is con ibu ing da a bu no na ional obse a o y has been es ablished. No pan-
Eu opean obse a o y has been o mally es ablished, al hough in e na ional agg ega ed da a is being used
and isualized ia he H20 Insigh Cen e
(h ps://public. ableau.com/app/p o ile/k. unk. ableau/ iz/H2OInsigh sCen e/H2OInsig sCen e), a public
acing dashboa d. Pa ien ec ui men also cu en ly si s a unde 1100 pa ien s acco ding o he Insigh
Cen e s a is ics. By de ining ou ecosys ems by da a sou ce and by echnical unc ionali y and wi h lexible
p agma ism, STRONG AYA’s ecosys ems can pe o m ea lie analysis on a la ge numbe o pa ien s o
gene a e insigh s ea lie .
Da a o he Common Good (h ps://commons.c i.uchicago.edu/) is an example o a s ong and e ec i e da a
insigh s ecosys em, wi h ela ed bu dis inc objec i es and me hods. I s ocus is ac oss diseases, bu
encompasses cance . I s each is in e con inen al, wi h a pa icula emphasis on diseases a ec ing young
child en, hough i ea u es an AYA cance wo king g oup. The ini ia i e p io i ises exis ing da a (in pa icula ,
STRONG-AYA – No. 101057482 – D5.5
om a communi y o expe s o help e ine i u he . T aining p og ammes o heal hca e
p o essionals on he echnical in as uc u e and on he use o PROMs in esea ch and clinical p ac ice migh
also help gene a e g ea e buy-in and suppo o sys ems ha use pa ien epo ed ou comes.
Longe i y/sus ainabili y
The STRONG-AYA app oach is adap able o se e al changes in echnology – ou use o Applica ion
P og amming In e aces ‘APIs’ o example is accep ing o he ine i able new so wa e implemen ed in
heal hca e cen es.
The echnology used in STRONG-AYA is i sel scalable bu is dependen on he esou ces o pa ne s wishing
o ge in ol ed and hei inancial and poli ical cons ain s. He e he lexible app oach o STRONG-AYA o
o e come hese di e ences will be pa amoun o longe i y, main aining inclusi i y and quali y o analysis.
The de elopmen he COS o AYAs wi h cance enables STRONG-AYA o o e new oppo uni ies o he
collec ion o homogeneous p ospec i e da a, which will suppo new esea ch and heal hca e inno a ion.
The agile and adap able app oach o FL allows lexibili y in inco po a ing exis ing sys ems and p ac ices in
la ge ecosys ems, allowing o he accommoda ion o new local con ex s and ecosys ems. Tools which will
enable and mo i a e s akeholde s o join and wo k oge he a e he websi es, speci ic ways o se -up o local
da abases, po als o s akeholde s o en e and access desi ed in o ma ion, and inally he access o he
expe ise equi ed o ope a e ecosys ems a local and Eu opean le els. Finally, STRONG-AYA will emain
esponsi e o eme ging and unan icipa ed e hical issues by adhe ing o i e a i ely de eloped e hical guidance
h oughou he du a ion o he p ojec , including pa ien -cen ed.
Close links, communica ion and collabo a ion wi h use g oups and s akeholde s a e i al o ensu ing ha
STRONG-AYA e ol es wi h hei needs and as new esea ch ques ions a ise in AYA. As a Conso ium he
inclusion o ea ly ca ee esea che s ac oss all disciplines will help ensu e ha ongoing success and longe i y
o STRONG-AYA.
10 Fu u e ac ions and conside a ions
The e a e a ange o u u e ac ions unde conside a ion: S ong-AYA can g ow and expand o example by
- Engaging o he local o na ional da a ecosys ems abou AYA-onse cance .
- Inco po a ing o he ypes o da a e.g. genomics, pha macological da a
- Widen unc ions and use cases, and adap ing whe e needed wi hin ou go e nance amewo k
A he hea o his a e he young people wi h li ed expe ience o cance . The STRONG-AYA ecosys em
p imacy o con inued pa ien in ol emen ecognises ha echnical solu ions a e only one pa o he
ad ances. The nex s eps need o ocus on scaling and sus aining meaning ul PPIE and co-design. As hose
wi h li ed expe ience lea n wi h he p ojec , hey become be e ad oca es and in aluable pee s in he
Conso ium, con ibu ing hei expe ise ac oss a ious domains, om esea ch and da a analysis o
ma ke ing echniques. STRONG-AYA is uniquely posi ioned o empowe AYAs wi h pe sonalized, ailo ed
in o ma ion and oppo uni ies o explo e hei own da a, all he while enhancing digi al heal h li e acy—a
skill c ucial o he 21s -cen u y. Th ough ime, his can esul in e e mo e seamless in eg a ion o esea ch

STRONG-AYA – No. 101057482 – D5.5
in o ou ine clinical ca e, so ha pa icipa ion bene i s indi iduals, socie y, as well as medical
communi ies. Achie ing hese goals equi es espec ing and expanding di e si y o pa ien pe spec i es,
wo king anspa en ly, and p io i izing e hics, p i acy, and secu i y.
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