Theme 05: Clinical Research

Infrastructures that are needed to support planning and execution of comprehensive Clinical Research including all research fields in oncology.

Established state-of-the-art capability platforms are available and reachable for the whole research community to support clinical research.

State-of-the-art technical platforms

Level 1

CR111
State-of-the-art technical platforms are planned and concrete initiatives are in the process of implementation.

Level 2

CR121
State-of-the-art technical platforms are available and in use in parts of the CCI.

CR122
A quality assurance program for state-of-the-art technical platforms is in place in parts of the CCI, ensuring that all processes are consistently reviewed, updated and improved.

Level 3

CR131
State-of-the-art technical platforms are available and in use in the whole CCI.

CR132
Data on the usage of platforms is collected systematically.

Level 4

CR141
State-of-the-art technical platforms are available and in use in the whole CCI, including the systematic integration of novel capabilities.

CR142
A quality assurance program for state-of-the-art technical platforms is in place in the whole CCI, ensuring that all processes are consistently reviewed, updated and improved.

CR143
There is an increase in the usage of platforms in a period of 5 years.

Established state-of-the-art capability platforms are available and reachable for the whole research community to support clinical research.

Organisational support

Level 1

CR112
Organisational support is planned and concrete initiatives are in the process of implementation.

Level 2

CR123
Organisational support is available and in use within parts of the CCI.

Level 3

CR133
Organisational support is available and in use for the whole CCI.

Level 4

CR144
A quality framework for organisational support is in place, ensuring that all processes are consistently reviewed, updated and improved.

Level 1 Level 2 Level 3 Level 4
Established state-of-the-art capability platforms are available and reachable for the whole research community to support clinical research.

State-of-the-art technical platforms

CR111
State-of-the-art technical platforms are planned and concrete initiatives are in the process of implementation.

CR121
State-of-the-art technical platforms are available and in use in parts of the CCI.

CR122
A quality assurance program for state-of-the-art technical platforms is in place in parts of the CCI, ensuring that all processes are consistently reviewed, updated and improved.

CR131
State-of-the-art technical platforms are available and in use in the whole CCI.

CR132
Data on the usage of platforms is collected systematically.

CR141
State-of-the-art technical platforms are available and in use in the whole CCI, including the systematic integration of novel capabilities.

CR142
A quality assurance program for state-of-the-art technical platforms is in place in the whole CCI, ensuring that all processes are consistently reviewed, updated and improved.

CR143
There is an increase in the usage of platforms in a period of 5 years.

Established state-of-the-art capability platforms are available and reachable for the whole research community to support clinical research.

Organisational support

CR112
Organisational support is planned and concrete initiatives are in the process of implementation.

CR123
Organisational support is available and in use within parts of the CCI.

CR133
Organisational support is available and in use for the whole CCI.

CR144
A quality framework for organisational support is in place, ensuring that all processes are consistently reviewed, updated and improved.

Equal accessibility to CTO (clinical trial office)

Presence of a Clinical Trial Office (CTO)

Level 1

CR211
A CTO is planned and concrete initiatives are in the process of implementation.

Level 2

CR221
A CTO for clinical research is available in parts of the CCI.

Level 3

CR231
A CTO for clinical research is available in the whole CCI.

CR232
A comprehensive quality assurance framework for clinical trial offices is in place in parts of the CCI, ensuring that all processes are consistently reviewed, updated and improved.

Level 4

CR241
A comprehensive quality assurance framework for CTOs is in place in the whole CCI, ensuring that all processes are consistently reviewed, updated and improved.

Equal accessibility to CTO (clinical trial office)

Institutional Review Board

Level 3

CR233
There is an Institutional Review Board which reviews all proposals to open a new trial within the CCI.

Equal accessibility to CTO (clinical trial office)

Collecting and analysing data

Level 2

CR222
Data on number and type of clinical trials is accessible to parts of the CCI.

Level 3

CR234
Data on number and type of clinical trials is accessible to the whole CCI.

Equal accessibility to CTO (clinical trial office)

Connection to biobanks

Level 4

CR242
Processes or procedures are in place indicating that biobanks are linked to clinical data.

Equal accessibility to CTO (clinical trial office)

Industry and academic clinical trials

Level 2

CR223
Industry-sponsored clinical trials are available in parts of the CCI.

CR224
Academic-sponsored trials are available in parts of the CCI.

Level 3

CR235
Industry-sponsored clinical trials are available in the whole CCI.

CR236
Academic-sponsored trials are available in the whole CCI.

Equal accessibility to CTO (clinical trial office)

Research nurses and dedicated clinical research time

Level 1

CR212
The CCI has research nurses available but not on a systematic basis.

Level 2

CR225
The CCI has research nurses available who are trained in clinical research.

Level 3

CR237
There are mechanisms for releasing clinicians' time to conduct clinical trials.

CR238
The CCI has research nurses available who are trained in clinical research and who are a team with defined leadership.

Level 4

CR243
Within the CCI there are mechanisms for protected time for clinicians to run clinical trials.

CR244
The trained research nurses within the team has increased over the last 5 years.

Equal accessibility to CTO (clinical trial office)

% cancer patients enrolled in clinical trials

Level 3

CR239
At least 5% of cancer patients within the CCI are enrolled in interventional clinical trials .

Level 4

CR245
At least 10% of cancer patients are enrolled in interventional clinical trials .

Continuous education for all clinical staff members in clinical research

Education for all clinical staff members

Level 1

CR213
Initial discussions have taken place to establish an educational and training programme for clinical staff members within the CCI.

Level 2

CR226
Education and training including regulatory aspects of clinical research for all clinical staff members is established in parts of the CCI.

Level 3

CR2310
Education and training including regulatory aspects of clinical research for all clinical staff members is established in the whole CCI.

Level 4

CR246
Education and training including regulatory aspects of clinical research for all clinical staff members is established and performed regularly in the whole CCI.

Level 1 Level 2 Level 3 Level 4
Equal accessibility to CTO (clinical trial office)

Presence of a Clinical Trial Office (CTO)

CR211
A CTO is planned and concrete initiatives are in the process of implementation.

CR221
A CTO for clinical research is available in parts of the CCI.

CR231
A CTO for clinical research is available in the whole CCI.

CR232
A comprehensive quality assurance framework for clinical trial offices is in place in parts of the CCI, ensuring that all processes are consistently reviewed, updated and improved.

CR241
A comprehensive quality assurance framework for CTOs is in place in the whole CCI, ensuring that all processes are consistently reviewed, updated and improved.

Equal accessibility to CTO (clinical trial office)

Institutional Review Board

CR233
There is an Institutional Review Board which reviews all proposals to open a new trial within the CCI.

Equal accessibility to CTO (clinical trial office)

Collecting and analysing data

CR222
Data on number and type of clinical trials is accessible to parts of the CCI.

CR234
Data on number and type of clinical trials is accessible to the whole CCI.

Equal accessibility to CTO (clinical trial office)

Connection to biobanks

CR242
Processes or procedures are in place indicating that biobanks are linked to clinical data.

Equal accessibility to CTO (clinical trial office)

Industry and academic clinical trials

CR223
Industry-sponsored clinical trials are available in parts of the CCI.

CR224
Academic-sponsored trials are available in parts of the CCI.

CR235
Industry-sponsored clinical trials are available in the whole CCI.

CR236
Academic-sponsored trials are available in the whole CCI.

Equal accessibility to CTO (clinical trial office)

Research nurses and dedicated clinical research time

CR212
The CCI has research nurses available but not on a systematic basis.

CR225
The CCI has research nurses available who are trained in clinical research.

CR237
There are mechanisms for releasing clinicians' time to conduct clinical trials.

CR238
The CCI has research nurses available who are trained in clinical research and who are a team with defined leadership.

CR243
Within the CCI there are mechanisms for protected time for clinicians to run clinical trials.

CR244
The trained research nurses within the team has increased over the last 5 years.

Equal accessibility to CTO (clinical trial office)

% cancer patients enrolled in clinical trials

CR239
At least 5% of cancer patients within the CCI are enrolled in interventional clinical trials .

CR245
At least 10% of cancer patients are enrolled in interventional clinical trials .

Continuous education for all clinical staff members in clinical research

Education for all clinical staff members

CR213
Initial discussions have taken place to establish an educational and training programme for clinical staff members within the CCI.

CR226
Education and training including regulatory aspects of clinical research for all clinical staff members is established in parts of the CCI.

CR2310
Education and training including regulatory aspects of clinical research for all clinical staff members is established in the whole CCI.

CR246
Education and training including regulatory aspects of clinical research for all clinical staff members is established and performed regularly in the whole CCI.

Broad access to clinical research in other CCIs

Collaboration

Level 1

CR311
Initial discussions have taken place regarding collaboration between CTOs in different CCIs.

Level 2

CR321
Written agreements on collaboration between CTOs in different CCIs are established.

Level 4

CR341
Patients have access to clinical trials outside of their CCI.

Broad access to clinical research in other CCIs

% cancer patients enrolled in multicentre trials
Active participation in high expert networks aiming to improve clinical research

Establishment of networks

Level 1

CR312
Initial discussions on organising working groups have taken place.

Level 2

CR322
Co-authored publications involving different professionals in different parts of a CCI and/or across CCIs have been published.

CR323
Working groups have been organised on a CCI level.

Level 3

CR331
Data on the number and impact factor of publications originating from networking activities are collected systematically.

CR332
Working groups have been organised across different CCIs.

CR333
Workshops, conferences, seminars, or symposiums on clinical research have been organised.

Level 4

CR342
The number of publications from networking activities has increased in a period of 5 years.

CR343
Working groups have been organised across different European countries.

Active participation in high expert networks aiming to improve clinical research

Networks of MTB

Level 3

CR334
An initial knowledge and experience exchange between different molecular tumour boards (MTB) has been performed.

Level 4

CR344
A network of molecular tumour boards between CCIs and/or across CCIs is established.

Level 1 Level 2 Level 3 Level 4
Broad access to clinical research in other CCIs

Collaboration

CR311
Initial discussions have taken place regarding collaboration between CTOs in different CCIs.

CR321
Written agreements on collaboration between CTOs in different CCIs are established.

CR341
Patients have access to clinical trials outside of their CCI.

Broad access to clinical research in other CCIs

% cancer patients enrolled in multicentre trials
Active participation in high expert networks aiming to improve clinical research

Establishment of networks

CR312
Initial discussions on organising working groups have taken place.

CR322
Co-authored publications involving different professionals in different parts of a CCI and/or across CCIs have been published.

CR323
Working groups have been organised on a CCI level.

CR331
Data on the number and impact factor of publications originating from networking activities are collected systematically.

CR332
Working groups have been organised across different CCIs.

CR333
Workshops, conferences, seminars, or symposiums on clinical research have been organised.

CR342
The number of publications from networking activities has increased in a period of 5 years.

CR343
Working groups have been organised across different European countries.

Active participation in high expert networks aiming to improve clinical research

Networks of MTB

CR334
An initial knowledge and experience exchange between different molecular tumour boards (MTB) has been performed.

CR344
A network of molecular tumour boards between CCIs and/or across CCIs is established.

Active patient involvement in all clinical research phases

Training and education

Level 1

CR411
Specialised training programs for clinicians and patient representatives are planned.

Level 2

CR421
Specialised training programs for clinicians and patient representatives are available and in use within parts of the CCI.

Level 3

CR431
Specialised training programs for clinicians and patient representatives are available and in use within the whole CCI.

Active patient involvement in all clinical research phases

Advisory board/ active involvement of patient representatives

Level 1

CR412
A patient advisory board is concretely planned.

Level 2

CR422
A patient advisory board is established.

Level 3

CR432
There is an active inclusion of patient representatives in every step of the research planning-, design- and decision-making process for academic studies in parts of the CCI.

Level 4

CR441
There is an active inclusion of patient representatives in every step of the research planning-, design- and decision-making process for academic studies in the whole CCI.

Level 1 Level 2 Level 3 Level 4
Active patient involvement in all clinical research phases

Training and education

CR411
Specialised training programs for clinicians and patient representatives are planned.

CR421
Specialised training programs for clinicians and patient representatives are available and in use within parts of the CCI.

CR431
Specialised training programs for clinicians and patient representatives are available and in use within the whole CCI.

Active patient involvement in all clinical research phases

Advisory board/ active involvement of patient representatives

CR412
A patient advisory board is concretely planned.

CR422
A patient advisory board is established.

CR432
There is an active inclusion of patient representatives in every step of the research planning-, design- and decision-making process for academic studies in parts of the CCI.

CR441
There is an active inclusion of patient representatives in every step of the research planning-, design- and decision-making process for academic studies in the whole CCI.

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