Working Group 3

Implementation of BBP guidelines:
demonstrator project COPD

Working group 3 will apply the developed BBP guidelines in ongoing biomarker studies on COPD. A number of CliniMARK network members are currently involved in projects that focus on clinical feasibility studies on biomarkers in COPD. To demonstrate the value of the BBP, the development plan for one COPD biomarker, developed in WG 3, tasks 3 and 4, will be executed in running projects on COPD biomarkers. This will result in new study designs on specific biomarkers in COPD. In addition, two reports will be produced, one to describe the practical issues encountered during implementation of the guidelines, and one to describe the success of implementing BBP.

Objectives

To implement BBP guidelines in ongoing biomarker studies on COPD

Tasks

1

To rank COPD biomarkers according to physico-chemical properties (e.g. size, charge, concentration) and their phase of development.

2

To classify COPD biomarkers according to clinical use (e.g. diagnostic, prognostic, companion diagnostic, etc.)

3

To define a BBP analytical development plan for each COPD biomarker, defining the chosen research-grade biomarker detection technique and analytical validation plan, and identifying the necessary expertise to execute the development plan.

4

To define a BBP development plan for clinical feasibility studies for each classified COPD biomarker, defining the biological samples, the data processing tools, data reporting methods, study design and read-out parameters, and statistical models that are needed for each biomarker, and timelines for all separate parts of the development plan.

5

To identify the most suitable CliniMARK members for execution of the COPD biomarker development plan for analytical validation of biomarker detection test.

6

To identify the most suitable CliniMARK members for execution of the development plan for COPD biomarker clinical feasibility studies.

7

To establish and document the pipeline for the clinical feasibility studies on COPD biomarkers describing what will be performed, who will perform it, and when it will be finished.

8

To manage the established research network and timelines

9

To document hurdles and successes.

10

To hold an interdisciplinary scientific symposium after completion of the development plan for COPD biomarker clinical validation to discuss encountered hurdles and successes.

11

To develop a publication on practical issues and solutions, and successes while implementing the BBP guidelines on COPD biomarker clinical feasibility studies.

Activities

These tasks will be organized through video conferences

  • Tasks 1-7

    WG meeting

  • Tasks 3,4 & 5

    Short-Term Scientific Missions (STSM)

  • Tasks 6

    a scientific symposium

  • Tasks 7

    development of dissemination material and scientific publications

Major deliverables

BBP development plan for COPD biomarkers.

Publication of report on practical issues while implementing the BBP guidelines

Publication of report on success of implementing BBP guidelines

Interdisciplinary scientific symposium, meeting minutes available on website

Milestones

Established BPP development plans for select COPD biomarkers.

Start of execution of development plan for one COPD biomarker.

Successful completion of development plan for on COPD biomarker.