national platform for investigator-initiated

oncological multicenter studies 4 September 2017

Agenda

• Goals & ambitions • Governance • Start DORP • How can I participate • Discussion

Our ambition

More trials of better quality that are timely completed for more patients!

I

Improving the infrastructure for clinical research complementary to data and biobank infrastructure

In scope

Cancer

Clinical (translational)

Multicenter

Investigator-initiated

Phase 2 and 3

Not in scope (but complementary)

Data and biobank infrastructure, e.g. HMF and Health RI a

Phase 1 and 4

Not (yet) in scope

Pharma-initiated research

I II

III

IV

a. HMF = Hartwig Medical Foundation (evolved from the Center for Personalized Cancer Treatment , CPCT) Health RI (RI = research infrastructure) has been developed by BBMRI-NL and others

II

III

IV

Main objectives Stakeholders: tuning procedures and formats, exchange of knowledge and best practices

Statistical support: innovative design and conduct of trials, optimal usage of data, spin-off research

Clinical project management: contribution to all aspects of a clinical trial

Monitoring: hybrid model for sites, risk-based per study

Patient advocates: involve in design and conduct of trials

Initial focus on 4 main tasks

DORP in the road map of trial design & conduct

Research group or investigator: development of trial concept

logistic and early statistical support of trial design, support of protocol development and grant writing

Funding source: review, when positive:

trial implementation and –management, quality assurance

DORP personnel

• DORP has limited central staff – Managing director – Administrative staff

• Personnel for required services will be accommodated at

institutes with specific expertise* – Project managers – Statisticians – Monitors – Etc.

* Advantages with respect to training, career development, etc.

Improved representation at stakeholders 1

a

a

Research groups Data centers

2020 ambition The platform is the primary contact in

The Netherlands for investigator-initiated Clinical Cancer Research

b

Other organisations, including funding sources

a. SONCOS and NFK involve all professional and patient associations, respectively b. VWS includes all related governmental organizations like the Health Care Inspectorate (IGZ) and The National Health Care Institute (ZiNL)

4) future situation

Governance

Task forces

STZ NFU

NFK …

… KWF

Sounding board

NVZ

Member Council

Board

DORP manager

Support team

Project management Statistics Monitoring &

QA Patient

involvement

Research group

Data center

IKNL

Patient advocate External stakeholder

5) cooperation

Member Council

Board

DORP manager

Council • Appoints members of the Board • Monitors objectives of cooperation • Offers (un)solicited advice to the Board

Board • Appoints and supervises DORP manager • Monitors annual financial statements • Performs stakeholder management • Defines strategy and policies of DORP

Responsibilities & authorizations 5) cooperation

Members • Oncological research groups & data centers

supporting oncological trials • Should meet basic quality criteria • Custom-made agreements with cooperation

Governance, on a day-to-day basis 1

DORP manager

Support team

Task forces

Project management Statistics Monitoring &

QA Patient

involvement

IT & Financial management

Research group

Data center

IKNL

• Multiannual projects for monitoring, trial statistics, clinical project management and patient involvement

• DORP manager evaluates project progress and budgets

• Project leaders appointed by centers with specific expertise

• Budget based on project plan • Cooperation between

various parties, involvement based on financial settlements

5) cooperation

Start DORP

KWF funding for 48 months, distributed in 3 periods

Period I Period II Period III

Start 1-1-2018

Evaluation August 2018

Evaluation 2021 2022

Detailed plan of action • Governance • Criteria for trial selection • Work plan • Monitoring parameters, etc.

Progress reports incl. milestones, KPI, financial reports, etc.

DORP is established and has reached financial self-sustainability

Activities Period I

• Formalize cooperation and formal participation

• Harmonize standard procedures, i.e. approval hospitals

• Practical roadmap with harmonized trial management guidelines,

formats, etc.

• Set up (hybrid) monitoring system

• Support in setting up structural and active patient involvement

Support for research groups Period I

• Support by set-up 3-4 new trials Support protocol development:

• statistics & design (STAT) • input monitoring / quality assurance (MON) • Input study logistics (PM) • Input patient perspective (pilot with PAG)

Support Grant writing (eg KWF-GMS system, budget; PM) Feasibility survey (PM)

• Criteria for research group

Research question from daily practice , result directy to be implemented in guidelines, no financial support available from pharma;

PI available for protocol writing including literature searches and grant application; Contact list Dutch investigators already involved in research for this tumor type.

• Selection by DORP board

Discussion