Working Group 2

Biomarker clinical feasibility study design

Working group 2 will develop a consensus on how clinical feasibility studies on biomarkers will be performed in three phases. First, the Working Group will establish a consensus plan on the use of biobanks for clinical feasibility studies of COPD biomarkers. Second, the working group will establish a consensus on clinical feasibility study design and readout parameters for COPD biomarkers. Ultimately, Working Group 2 will write a whitepaper on BBP in biobanking and clinical feasibility studies by integrating considerations made in establishing the development plan for COPD. This will ensure that multiple studies on the same biomarkers make use of tissue samples of comparable quality, and report on the same outcome parameters. As a result, the outcomes of clinical feasibility studies can be compared between multiple sites, which will increase the confidence in biomarkers.

Objectives

To establish a BBP whitepaper for clinical validation of reliable biomarkers.

Tasks

1

To take inventory of existing sample collection methods, sample storage methods, data collection, processing and storage methods, data analysis methods, data reporting methods, and existing guidelines for biobanking for COPD biomarker studies.

2

To evaluate existing clinical feasibility studies of biomarkers to identify ‘best practice in study design (e.g. sample size, type of control vs patient group, necessary meta-data, necessary raw data, age and gender matching, statistical methods, etc.), relevant read-out parameters (e.g. sensitivity, specificity, clinical impact, economic impact, etc.), and statistical models for each biomarker class defined in WG2, task 1.

3

To evaluate the identified methods for biobanking under task 2 and the identified clinical feasibility studies under task 3, for each of the classified COPD biomarkers under task 1.

4

To integrate considerations, and identified hurdles and solutions for clinical feasibility study of COPD biomarkers into a BBP guideline.

5

To develop a whitepaper for BBP for clinical feasibility studies:

5.1

On biobank building and maintenance and

5.2

Clinical feasibility study design and read-out parameters.

6

To set up new research lines to improve the methods included in the BBP (e.g. sample handling, storage, data processing, meta-data deposition).

Activities

These tasks will be organized through video conferences
  • Tasks 1-8

    WG meeting
  • Tasks 2 & 4

    Short-Term Scientific Missions (STSM)
  • Tasks 5 & 7

    a scientific symposium
  • Tasks 5 & 7

    development of dissemination material and scientific publications

Major deliverables

BBP guidelines for clinical feasibility studies on biomarkers.

New research proposal to develop solutions to improve methods in the BBP guidelines.

Milestones

Publication of BBP white paper on clinical feasibility studies on biomarkers.