Plataforma de Unidades de Investigación Clínica y Ensayos

Clínicos (SCREN), PT13/0002/001, financiada por el PE de

I+D+i 2013-2016 y por la Subdirección General de Evaluación y

Fomento de la Investigación- Instituto de Salud Carlos III

(ISCIII). Este proyecto está cofinanciado con fondos FEDER

Funded by:

ECRIN previous experience

Star working together

Arise your interest in work with ECRIN as partner in your Clinical trials proposals

Talking about independent clinical

trials?

How this infrastructurehas been designee to

help me as investigator?

What are ECRIN & SCReN ?

What can you do for me?

Clinical trial

▪ A descentralice (transversal) network

▪ Not legal entity

▪ Funded by ISCIII through a public call:

▪ PT 13: 2014-2017▪ PT 17: 2018-2021

▪ Support the conduct of multicentreclinical trials across Spain

▪ 29 Clinical Trials Units

▪ A non-profit organisation

▪ With the legal entity

▪ European Research InfrastructureConsortium (ERIC)

PT 13: 2014-2017T 17: 2018-2021

▪ Support the conduct of multinationalclinical trials across Europe

▪ 9 Member and Observer Countries

ECRIN SCReN

Why independent clinical trials

need support?

The study quality has a direct relation with:▪ Scientific methodology▪ Process reliability▪ Ethic-regulatory guidelines commitment

Investigator initiated clinical trials success is bounded to▪ Consellour▪ and technical knowledge

for the plan and execution (from an operative point of view).

A network structure is the best option to undertake cooperative clinical research projects

How much do clinical trials cost?

Nature Reviews Drug Discovery 16, 381–382 (2017)

19 May 2017

59 %

Reduce costImprove

efficiency

Independent clinical trials reality

NEEDS______________________

Human resources

Material resources

Funds

FURTHER NEEDS______________________

Coordination

Experience

Training

Communication

Quality

Infrastructure interoperability,, management, cost models, funding,

languages, etc.

Regulation, ethical review, insurance, contracts

Solution for this obstacles

PROVIDES SUPPORT TO SPONSORS IN INVESTIGATOR-INITIATED TRIALSA PATHWAY THROUGH EUROPE’S FRAGMENTED HEALTH AND LEGAL

SYSTEMS

Greater access to patients, medical expertise and appropriate facilitiesHigher methodological standards

Shared costs, tools and proceduresPotential for broad implementation of research outcomes

Avoidance of duplication of trials

History at a glance

2014

2015

2016

2017

2018

2019

2020

1. ECRIN2. National Partner:

SCReN3. Clinical Trial Units

INFRASTRUCTURE

1. ECRINOrganisation: Distributed Infrastructure

Core Team

▪ Develops ECRIN’s strategy, common tools and procedures

▪ Supports EuCos

European Correspondents (EuCos)

▪ Implement work in-country in coordination with

national partners

National Partners (networks of clinical trial units, CTUs)

▪ Manage trials in-country and provide services to ECRIN▪ Host EuCos

Main Activity: Coordinated Support

from Preparation to Implementation

2. SCReN: Spanish National PartnerDecentralized Network Structure

Efficiency▪Avoid duplicities▪Synergies

Complete servicesthroughout the clinical trial life cycle:▪Design▪Star Up▪Development▪Close out▪Disemination/reporting

2. SCReN: Spanish National PartnerOrganisation: Programs

PMBGD PFV PRM

PFV

PMBGD

PRM

PCF

Training

Quality

IT

Coordination

Project

2. SCReN: Spanish National PartnerOrganisation: Programs and projects

Data Manager

Clinical Trial Manager

Bio-Statistician

PhVResponsible

Star Up teamMonitoring

team

CTAs CRAs

PMBGD PFV PRM

3. Clinical Trial Units (UICECs)

Unit UICEC Clinical Trial Unit

Clinical Trial Units (UICECs)

29 Clinical Trial Units covering 11 regions:

• Madrid• Cataluña• Andalucía• Euskadi• Valencia• Galicia• Extremadura• Castilla/León• Navarra• Cantabria• Murcia

Associated Clinal Trial Units

Helping Investigators

CTU

Yellowish line: coordinated clinical trials Blue line: clinical trials involving the country

Spain activity in ECRIN

ECRIN as a partner in a H2020

Clinical Trial

DraftProposal

First Contact

ECRIN assessment for

participation

Information required by EuCos:▪ Consortium members▪ Call information (+ deadlines)

▪ Project synopsis (as advanced as

you can)

▪ About the trial: ▪ Enrollment countries▪ Sites▪ Sample size

▪ ECRIN request description

Core Team (Paris)

Quick evaluation for acceptance

Euco link with the Core Team, other

EuCos, national scientific partners,

and trial stakeholders

ECRIN/SCReN more than a CRO ▪ Support investigators to prepare applications for multinational funding:

logistical and operational components

▪ Provide guidance on the services required for a trial, and logistical and operational aspects: regulatory and ethical issues, insurance, contracting, trial monitoring, costs

▪ Coordinate logistical assessments:

▪ Assess the availability/feasibility of services

▪ Identify CTUs

▪ Lead cost calculation for defined services

▪ Provide guidance on the committee constitution (DSMBs; Steering committees; advisory boards…)

▪ Provide advice on data sharing