SCTO platforms and what will change? - CTU Bern...Platforms were planned (in early 2017) as a...

CTU Bern – CTU lecture 13.09.2017 1

SCTO platforms – and what will

change?

Bern, 13.09.2017


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?


SCTO – organisational charter and governance

Board of CTU

Directors - execution

consults/advises

Steering Board – strategy & direction(= membership assembly)

Advisory

Board

swiss-

ethics

SGPM SGKPT SwAPP

Science

industr.inter-

pharmaSNSF

*non-voting member

Extern.

financial

officer

Independent

financial audit

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gives directives

SCTOExecutive Office

Platform 1 Platform N

SERI


Tasks of the SCTO

Coordination CTU-Network

Cooperation hub


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.


With whom do we interact?

Authorities

(ECs / CA)

Clinical Researcher

& Team

Sponsor

(industry & academia)Partners

Patients


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)


SCTO Organisation - Partners


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.


Overview

Platforms:

Further platforms will follow (education, safety)


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.


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.


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.


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


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


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.


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.


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.


Last but not least


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

[email protected]

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