WP1 sets out the ‘ethics requirements’ that the Project must comply with.
0%
WP1 sets out the ‘ethics requirements’ that the Project must comply with.
The goal of WP2 is to establish and guarantee full synergy, motivation, and effective interactions among NECESSITY participants with the final aim of delivering successful progresses of the Project within the agreed time, cost and quality limits as defined by the Grant Agreement signed with the IMI2 JU and the Consortium Agreement signed among the Participants.
The objectives of WP3 are: 1) To study and validate tissue-based biomarkers able to capture pathogenic mechanisms leading to inflammation and organ damage and to explore the relationship between biomarkers of organ inflammation, long term outcome of disease progression and response to therapeutic intervention, in order to provide organ-based biomarkers to stratify patients and monitor response to therapy; 2)To establish the functional relationship between the newly designed clinical endpoints and organ specific biomarkers of organ involvement and damage; and 3) To validate novel platforms and assays for biological analysis using the results and clinical material derived from the NECESSITY clinical trial.
The aims of WP4 are: 1) To identify biomarkers for patient stratification and predictive biomarkers of therapeutic responses that will be assessed retrospectively in the NECESSITY clinical trial; 2) To identify blood-based biomarkers that predict/correlate with (i) major organ manifestations; (ii) organ damage (reversible and irreversible) and (iii) long-term outcomes such as lymphoma development; 3) In partnership with WP3, to understand the relationships between the above blood-based biomarkers and the tissue-based biomarkers identified in WP3; and 4) In partnership with WP5, to explore how these biomarkers may complement the clinical endpoints developed in WP5 for the evaluation of therapeutic interventions.
The objectives of WP5 are: 1) To define trial entry criteria for the clinical trial (WP6) by identifying patient subsets having the most chance to improve with treatment; 2) To develop a new composite responder index in pSS referred to as “Sjögren’s syndrome Tool for Assessing Response” (STAR) that will be used as secondary endpoint of the clinical trial (WP6); and 3) To develop secondary endpoints that will be innovative tools to capture the potential effects of therapy on the many different facets of the disease.
The goals of WP6 are: 1) To validate the new clinical endpoints developed in WP5; 2) To design an original trial that could involve all the subtypes of patients with pSS; and 3) To maximize the chance of finding a difference in clinical effectiveness between the active and placebo arms for validating the new clinical endpoints.
The objective of WP7 is to provide promotion, support and services for the management of the NECESSITY clinical trial, according to ICH-GCP guidelines and national and international regulations.
The objectives of WP 8 are: 1) To develop links between clinical outcomes and value creation by reaching consensus with key stakeholders regarding the use of previous and new endpoints for regulatory approvals and reimbursement in the management of primary Sjögren’s syndrome; 2) To identify healthcare delivery needs, gaps and opportunities and provide insight into policy evolution; and 3) To ensure that patients’ views are appropriately elicited and well represented throughout, in order to capture relevant (primarily clinical) disease aspects, which are currently overlooked or underestimated.
WP9 will focus on the ethical and legal governance of the Project, ensuring that full account is taken of the legal and ethical issues at stake. WP9 tasks will aim at protecting the rights of patients in the NECESSITY Project and in particular ensure that the patients’ perspective on data sharing, consent and data privacy are considered in all project steps in full compliance with the new General Data Protection Regulation (GDPR). In addition, WP9 will provide guidance to the WPs in charge of the protocol as well as the informed consent development and the clinical trial realization with regards to ICH guidelines compliance and GDPR general principles.
WP9 will also ensure that adequate safeguards are in place to allowing personal data transfers of EU data subjects to third countries or international organizations. This includes mandating organizations that control or process such data to comply with these requirements.
The objectives of WP10 are: 1) To communicate and disseminate the project results beyond the project Partners to a large audience and potential users of the results, including the clinical/scientific community and the general public; 2) To reinforce the scientific position of the clinical, academic and EFPIA Partners; 3)To facilitate and promote interaction with stakeholders (patients and their families, clinicians, pharmaceutical industry, regulatory agencies and HTA bodies); 4) To give to the scientists involved in the Project an advanced training; and 5) To translate the achievements and results into new therapeutic approach for clinical use and public health benefit, into useful tools for R&D (pharmaceutical industry), thus ensuring the implementation and exploitation of the project results.
