Leaders:
Dr James Bluett (WG3 Leader)
Dr Floris Loeff (WG3 Co-Leader)
Objectives:
This WG will be responsible for several overarching activities needed for an optimal functioning of WG1 and WG2. First, this WG will investigate and implement measures for the harmonisation and standardisation of TDM assays to be able to compare the results of different hospitals/research centres. Second, WG3 will be responsible for setting up a comprehensive overview of patient data/samples that could be used to facilitate multicentre clinical trials (e.g., the number of chronic inflammatory disease patients receiving treatment within each participating hospital/research centre, how many patients receive a certain therapeutic antibody, the number and quantity of well-documented (serum) samples available for retrospective analyses, the availability of TDM assays, etc.) but without sharing the patient data/samples themselves.
This structured overview will be important to find partners for setting up large retrospective and prospective multicentre trials because it will provide detailed information on how many patients could be included from each hospital/research centre. The design of the clinical study is a huge effort that needs staff and the commitment of hospitals (clinicians, experts in modelling, pharmaco-economists, laboratories, etc.).
Tasks and activities:
- T1: Evaluate the differences between available TDM assays for measuring serum drug and ADA concentrations to harmonise procedures and propose universal standards.
- T2: Coordinate laboratory sample exchange programmes as external quality control.
- T3: Select the most relevant markers of disease activity and quality of life.
- T4: Collect data from the participating hospitals/research centres on number of patients, number of well documented samples, availability of TDM assays, etc. by mailings and questionnaires.
- T5: Set up and regularly update an overview of the above-mentioned data on participating hospitals/research centres (number of patients, number of samples, availability of TDM assays, etc.) in a database format, to be made available to the network members on the Action website.
- T6: Explore the feasibility of e-Health in the perspective of setting up a European funded application (research agenda), with the support of the Digital health data and services – the European health data space.
Deliverables:
- D1: Publication of scientific papers on the differences between the available TDM assays and how the results obtained by each TDM assay can be compared to the other available assays.
- D2: Proposal of universal standards for TDM assays of each therapeutic antibody.
- D3: Sending out a standard questionnaire (PRO: patient reported outcomes) for collecting data on the available patients/samples and TDM assays to the participating hospitals/research centres.
- D4: Publication of a structured and regularly updated overview of hospitals/research centres interested to participate in multicentre studies on the Action website.