Post on 08-Jul-2020
CTU Bern – CTU lecture 13.09.2017 1
SCTO platforms – and what will
change?
Bern, 13.09.2017
CTU Bern – CTU lecture 13.09.2017 2
Switzerland faces a decline in the number of clinical research projects
being performed.
However different stakeholders are not only concerned about quantitative
aspects, but also about quality issues.
Challenges to be addressed:
•The administrative complexity of clinical-trial processes
•The “one size fits all” approach to the management of clinical trials
•The need to improve the education and training support as well as the
infrastructure framework in clinical research, and the involvement of
patients
Why SCTO?
CTU Bern – CTU lecture 13.09.2017 3
SCTO – organisational charter and governance
Board of CTU
Directors - execution
consults/advises
Steering Board – strategy & direction(= membership assembly)
Advisory
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SCTOExecutive Office
Platform 1 Platform N
SERI
CTU Bern – CTU lecture 13.09.2017 4
Tasks of the SCTO
Coordination CTU-Network
Cooperation hub
CTU Bern – CTU lecture 13.09.2017 5
SCTO Organisation
The CTU network:
• Forms a well-established and nationally coordinated clinical
research infrastructure.
• Each CTU coordinates a platform for clinical research.
Altogether, about 150 people work for this network.
CTU Bern – CTU lecture 13.09.2017 6
With whom do we interact?
Authorities
(ECs / CA)
Clinical Researcher
& Team
Sponsor
(industry & academia)Partners
Patients
CTU Bern – CTU lecture 13.09.2017 7
What do we contribute?
Authorities:
Support (inter)national harmonisationand simplification of processes
(examples: roundtables, broadconsent...)
Clinical Researcher & Team:
Services and training
(examples: „academic CROs“, largesttraining provider, Roadmap next
generation of clinical researchers...)
Sponsor (industry & academia):
Prepare the ground, liaise with Europe...
(examples: trained professionals@sites, ECRIN...)
Partners:
Act as platform, no parallel infra-structures, stakeholder management...
(examples: SwissBiobank / SwissPedNet / SAKK / ECRIN....)
Patients
Support empowerment(EUPATI)
CTU Bern – CTU lecture 13.09.2017 8
SCTO Organisation - Partners
CTU Bern – CTU lecture 13.09.2017 9
Overview
„History“ of the platforms:
Mandate from the State Secretariat for Education, Research and
Innovation (SERI) to “streamline” clinical research infrastructures.
Platforms were planned (in early 2017) as a consequence of the
finally limited funds received from SERI. The initial concept was
reduced accordingly.
Each CTU coordinates one platform and has to contribute to the
other platforms – centres of excellence pooling experts from
different institutions.
CTU Bern – CTU lecture 13.09.2017 10
Overview
Platforms:
Further platforms will follow (education, safety)
CTU Bern – CTU lecture 13.09.2017 11
Aim of the platforms
The platforms should serve internal and external clients:
Harmonise and improve processes within the network
Set national standards and recommendations (e.g. facilitating
the conduct of multicentre studies) and ensure international
compatibility.
Be the first contact point for authorities and other national and
international stakeholders when questions arise regarding any
topic in clinical research.
CTU Bern – CTU lecture 13.09.2017 12
Current situation (I)
Data Management Platform (coordinated @ CTU BS):
Code Libraries, centralised IT-systems, CRF validation
Data Management Plan guidelines from SNF
ECRIN data centre certification
SPHN call/funding
SecuTrial (new features, bugs, alternative software)
Project Management Platform (coordinated @ CTU SG):
Develop concrete tools for study teams like e.g. an electronically
available clinical trial.
CTU Bern – CTU lecture 13.09.2017 13
Current situation (II)
Biostat/Methodology Platform (coordinated @ CTU BE):
Increase collaboration of CTUs (and partners) in the field of
(bio)statistics and clinical research methodology
Provide a platform for networking of individual biostatisticians working
on Swiss academic clinical research projects
Establish standards/guidelines for statistical topics within the CTU
network
Audit Platform (coordinated @ CTU ZH):
Build up: Audit Professionals Platform, SCTO Auditor Pool, Point of
Contact / communication network.
Monitoring Platform (coordinated @ CTU GE):
Prioritised objectives: standardize the monitoring plan(s), facilitate
contracting and reduce the bureaucratic burden in general.
CTU Bern – CTU lecture 13.09.2017 14
Current situation (III)
Regulatory Affairs Platform (coordinated @ CTU LS):
Prepare / anticipate roundtable discussions: e.g. clarify GCP and
ClinO requirements
Take part to elaboration & revision of templates and best practices
Participation to revision of HRA.
The RA platform could become the main SCTO contact point for
swissethics and CA
Education platform @ SCTO EO:
Andri Christen will join the SCTO EO and build-up the Swiss Clinical
Research Education Center SCREC (part of FOPH Roadmap for the
next generation of clinical researchers). This is done with the
education experts of the network.
Safety Platform
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Future
Benefit of synergies between platforms
6 x 1 platform = > 6 platforms
Example for potential synergies:
DM & Monitoring (& Biostat): recommendations and procedures for
remote monitoring procedures
CTU Bern – CTU lecture 13.09.2017 16
What will change?
More (and faster) nation-wide harmonisation, cooperation,
exchange and dissemination of know-how and practical
recommendations including related tools.
Clear national contact points for specific topics thanks to centers of
excellence.
More exchange and alignment with Europe and beyond.
CTU Bern – CTU lecture 13.09.2017 17
What is not going to change?
CTUs remain the local contact point for services – platforms do not
offer services on a project basis!
Services needed to properly conduct clinical study projects will
continue to be specifically offered decentralised at the CTUs.
CTU Bern – CTU lecture 13.09.2017 18
Summary
Platforms as centers for excellence in clinical research should
significantly add to an attractive Swiss place for research being
more in line with European and international developments.
The overriding goal remains:
The activities of the SCTO and its network should continue to
support the successful development of new therapies or to improve
existing treatments.
CTU Bern – CTU lecture 13.09.2017 19
Last but not least
CTU Bern – CTU lecture 13.09.2017 20
The SCTO is an independent organisation and is
based on a joint initiative of the Swiss National
Science Foundation and the Swiss Academy of
Medical Sciences.
As of 2017, the SCTO is a research infrastructure of
national importance funded by the State Secretariat of
Education, Research and Innovation and the Swiss
National Science Foundation.
Contact:
Annette Magnin, Managing Director
a.magnin@scto.ch