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CANADIAN CLINICAL TRIALSCOP ORDINATING CENTRE (CCTCC)
Ele na Am inkova , Inte rim Dire ctor of P roje ct Facilita tion
CCTCCwww.cctcc.ca [email protected]
CCTCC is a de m ons tra tion of the unique com m itm e nt be twe e n indus try,
gove rnm e ntand he a lthca reins titutions
to im prove the ope ra tiona l e nvironm e nt for clinica l
tr ia ls in Canada . The CCTCC’s key objectives are to improve the operational environment for clinical trials in Canada and promote the
country as a destination of choice for clinical trials.
www.cctcc.ca CCTCC
www.cctcc.ca
www.cctcc.ca
COLLOBORATION
NATIONAL ADVISORY GROUP
• Cross -Canad ian exper t group p rovid ing input & advice on CCTCC's activities
P ROVINCIAL CT ORGANIZATIONS’ MEETINGS• Fos ter collabora tion• Enga ge for p rojects • Identify em erging is sues• Prevent dup lica tion of effor t
Provincial CT Organizations Meetings
P ROV CT ORGSMEETINGS
www.cctcc.ca
SP EED-UP CT TIMES
WHAT IS CCTAM?• Web-based , ‘living, eas ily sea rchable, interactive da tabase of Canad ian
clinica l resea rch capab ilit ies : – inves tiga tors , c linica l resea rch s ites , hosp ita ls , ins titutions , resea rch
ethics boa rds , CROs, SMOs , e tc. • Firs t pan-Canad ian, pan-therapeutic, up-to-da te, resea rch inventory with
an integra ted m ap-based sea rch function• Currently over 1 1 0 0 as sets (4 0 % asset growth s ince launch in June 2 0 1 5 )• Ongoing e ffor ts to popula te He a lthCare CAN’s m e m be r ins titutions &
inve s tiga tors• Access the CCTAM here
www.cctam.ca |[email protected]
CCTAM
Canadian Clinica l Tria ls As s e t Map (CCTAM)
Showcase Canad ian
clinica l resea rch
a s sets
Expedite s tudy
feas ib ility process
An es sentia l tool for anyone on
conducting clinica l resea rch
in Canada
Unique in the world
Reduce clinica l
tria l s ta rt-up
tim es
www.cctam .ca
Placeclinica l tria ls
effectively andefficiently
Map of a s sets (1108 )
CCTAM webina rs ava ilable upon reques t .
CCTAM BENEFITS
BENEFITS & OP P ORTUNITIES
• Allows for p lacing clinica l tria ls (CT) effectively & efficiently reducing CT s ta r t-up tim es
• Facilita tes feas ib ility s tud ies conduct• Showcases exis ting ta lents & exper tis e in Canada &
ab ility to conduct cutting edge CTs• Allows for joining m ore CT & conduct inves tiga tor
initia ted -resea rch by sea rching for resea rch pa r tners acros s the country by com m on therapeutic a reas
CCTAM
PATIENT REGISTRIES• Popula ting in the CCTAM to facilita te CT feas ib ility
s tud ies & pa tient recruitm ent• Key criteria used in s electing regis tries :
Active registry 10 registrants min. Point of contact Diagnosis identified by an approved care team Data accessible to external parties for purposes of CT recruitment
• Introductions to Patient Registries are welcome
MODEL CLINICAL TRIAL AGREEMENT (m CTA)
m CTA
• Canada-wide initia tive to: s tanda rd ize CT a greem ents by develop ing langua ge for all
clauses bring efficiencies to clinica l resea rch proces s
• Collabora tion with CLEAR (TransCelera te-suppor ted) p roject to incorpora te CLEAR langua ge within the m CTA
• m CTA’s Team Canada cons is ts of s ite/ ins titution & sponsor representa tives
• Ultim a te goa l – ensuring Canada’s globa l com petitivenes s in a ttracting CTs
m CTA – CURRENT STATUS
m CTA- STATUS
• Adoption s tage a fter com prehens ive s takeholder consulta tions in 2015 & 2016
• Reviewed by an independent lega l counsel1 for cons is tency of term inology use & definitions , & cla rifying am biguous word ing
• m CTA Ve rs ion 8 , cons ulta tion re por t & com m unica tion de ck a re ava ilable for us e
• Vis it our webs ite here to access a ll m a teria ls & for m ore inform a tion
m CTA – ADOP TION
m CTA ADOP TION
Working to increase awarenes s of the m CTA& to encoura ge adoption
Meetings held in Toronto and Montréa l, with > 6 0 representa tives from 3 0 d ifferent s ites & 1 5 sponsors re adoption, im plem enta tion & next s teps to ensure full usa ge of the m CTA
Next m eeting in Ca lga ry - October 2 5 , 2 0 1 7
FAIR MARKET VALUE (FMV) P ROJ ECT
FMV
• Direct result of the m odel CT Agreem ent (m CTA) project
Goals :• Reduction of clinica l tria l (CT) budget negotia tion tim es• Reduction of CT s tudy s ta r t-up tim elines• Introduction of CT efficiencies and s tream lining of budget
negotia tions
Re as ons to tackle FMV:• Addres s increas ing CT s ta r t-up tim es• Ensure Canada’s CT com petit iveness globa lly
FMV BACKGROUND – STUDY START-UP• Canada s ta r t-up is com petitive com pared to Europe for CV but not for Oncology
tria ls• Challenges with s ta r t-up in Canad ian ins titutions (IRB, contracts , budgets )
USA
Cana
da
W E
urop
e
E Eu
rope
USA
WEu
rope
Cana
da
E Eu
rope
Protocol Approved
Protocol Approved
First Site Initiated
First Site Initiated
Cardiovascular Oncology5-10 months 5-10 months
FMV BACKGROUND
CONTRACT TIMELINES
CONTRACT TIMELINES
05
10152025
Legal Budget InternalSign-Off
Draft toFully
Executed
WEE
KSAverage Time for Contract Execution
2015-2016
INSTITUTIONSALL SITES
WHAT DOES FMV MEAN TO SP ONSORS?
• Bona fide service fees• Equitable fees• Defendable paym ents• Com pliance • Com petit ive Cos ts
FMV DEFINITION
WHAT DOES FMV MEAN TO SITES?
FMV DEFINITION
• Fram ework or resource to a s s is t in budget developm ent
• Where budget developm ent is cons is tent (e.g. centra l budget m ana gem ent) then the negotia tion p roces s is fa s ter
FMV AP P ROACH
FMV AP P ROACH
• Scope out sponsors ’ & s ites ’ FMV needs• Clarify key budget-rela ted ques tions of both s ites
and sponsors • Develop unders tand ing of both s ites and
sponsors ’ requirem ents , p res sures and ba rriers in CT budgeting
• Identify solutions such as bes t p ractices and benchm arks
DRIVERS FOR THE FMV INITIATIVE
KEY COST DRIVERS
• Varia tion in how budgets a re crea ted & negotia ted
• Unders tand ing of full cos ts & app lica tion of full cos t recovery
• Sponsor and CRO incons is tency can d rive s ite incons is tency
FMV P OTETNIAL BENEFITS
FMV BENEFITS
• Fas ter negotia tion p roces s
• Fram ework or resource (e.g. bes t p ractices ) to a s s is t in budget developm ent
• Com pliance
• Defendable paym ents
www.cctcc.ca
“ Clinica l Tria ls – the Canad ian Advantage ”Inve s tm e nt Cas e
P ROMOTE CANADA
• Cons is tent na rra tive com m unica ting Canada 's c linica l tria ls advanta ges globa lly focused on: Speed Quality Incentives
• Intended for p resenta tions to globa l offices of CT sponsors • Cus tom izable based on aud ience’s needs • Next s teps :
Poss ible add itiona l m odules Keep content upda ted
• Access here
www.cctcc.ca
Hos ted a t www.bccrin.ca / survey Firs t pan-Canad ian survey enab ling pa tients & hea lthy volunteers to p rovide input & advice
on their CT experience
Anonym ous , online experience survey by Clinica l Tria ls BC (form erly BCCRIN). Pa rt of the BC Academ ic Hea lth Science Network
Pan-Canad ian Expans ion supported by the CCTCC
Adults , or pa rents of a child , who have been invited to pa rticipa te in a clinica l tria l and either enrolled , declined or d id not m eet the s creening requirem ents a re eligib le
Part of a b roader s tra tegy to engage Canad ians in the clinica l resea rch proces s
Data will be used to im prove recruitm ent and retention outcom es for clinica l resea rch s ites , inves tiga tors and sponsors by develop ing s tra tegies des igned to addres s p rovincia l and na tiona l resea rch pa rticipant perspectives and concerns
Clinical Research Participation SurveyEngage. Listen. Act.
Clinical Research Participation SurveyUpdate October 2017• Enrollm ent ta rget of > 1 000 reached April 201 7
• Analys is by CHEOS com m enced Sep tem ber 201 7
• Results expected Novem ber 201 7
• Planned pub lica tion
• Knowledge trans la tion p lanning has com m enced
• Que s tions : Alison Orth a t Clinica l Tria ls BC - [email protected]
www.cctcc.ca
P ULSE CHECK
RESEARCH ETHICS BOARD REP ORT
• The im pact of the Canad ian experience of REB centra liza tion & ha rm oniza tion
• Recom m enda tions for the future to ensure Canada’s com petitiveness on a globa l s ca le
• CCTCC & Hea lth Canada p repa red a joint response to the WG’s repor t
• More inform ation is ava ilable here
REB REP ORT
REB WG REP ORT Contd . 1
• R# 1 - Dis tribute the SPOR SHRER Repor t Com m itteerecom m enda tions widely
• R# 2 - Es tablish a regis try of REBs tha t review and approve clinica l tria ls tha t could ult im a tely be expanded to encom pass a ll REBs in Canada
• R# 3 - Actively pursue regula tory op tions for s tanda rds equiva lency for REBs tha t review regula ted clinica l tria ls
• R# 4 - Coord ina te REB educa tion and tra ining effor ts , and conduct a needs a s ses sm ent of REB educa tion requirem ents
REB REP ORT
REB WG REP ORT Contd . 2
• R# 5 - Inves tiga te the feas ib ility of va rious approaches to sha ring REB reviews of m ulti-centre resea rch (includ ing a poss ib le online sys tem and a na tiona l da ta warehouse)
• R# 6 - Conduct a s tudy of rea l and perceived ba rriers to the accep tance of other REB reviews and pub licly report on the find ings and recom m ended
• R# 7 - Es tab lish a na tiona l s tra tegic leadership forum
CT METRICS
CLINICAL TRIALS METRICS• Quantita tive m etrics , e.g.:
# of newly random ized sub jects , opened s ites , tria ls , tria ls by phase in Canada & globa lly (phases I,II,II, IV, other)
• Opera tiona l m etrics , e.g.: avera ge tim e/ days to REB approva l, contract & budget
• Quality m etrics , e.g.: pa tient recruitm ent, va lid ity, re tention, & protocol & dos ing
devia tions (interna tiona l com parison)
• Inves tm ent m etrics , e.g.: tota l CT Inves tm ent in Canada (by p rovince) vs . other countries
(includ ing CROs)
