CFF National Resource Centre Award

Funding for cystic fibrosis research centres to provide core services to support the planning and implementation of clinical studies and trials.

The Cystic Fibrosis Foundation (CFF) is a US-based 501(c)(3) non-profit organisation established in 1955. Its mission is to cure cystic fibrosis (CF) and to provide all people with the disease the opportunity to lead full, productive lives by funding research and drug development, promoting individualised treatment, and ensuring access to high-quality, specialised care.

The CFF-supported National Resource Center (NRC) programme aims to provide ‘Cores’ of expertise to the CF clinical research community. NRCs interact regularly with independent investigators, the CFF, the CFF Therapeutic Development Network Coordinating Center (TDNCC) and potentially other data coordinating centers, Therapeutic Development Centers (TDCs) and independent industry sponsors in the planning and implementation of clinical studies and trials.

The CFF awards funding over five years to support the work of National Resource Centres, which will be active members of the CF research community by provide assistance and/or serve as a core for CF clinical studies and trials – which must include US-based studies.

Services provided by the NRCs include:

• Centralised and core-specific services.
• Training in specialised testing.
• Consulting to investigators and sponsors.
• Development of standard operating procedures and training for CF clinical research methodology.
• Standardisation of assays in multicenter clinical studies and trials.
• Advancement of biomarkers and clinical endpoints relevant to CF.

With advances in CF care and changing needs of the CF clinical research community, the CFF intends to support NRCs that will address and advance biomarkers and clinical outcome measures relevant to the evolving needs over the next five years.

NRC applications should focus on clinical research that addresses high priority topics in CF, which includes:

• Detection of CFTR in disease-effected and therapeutically restored epithelia.
• Patient cell/tissue-based testing of novel CFTR therapies.
• Bacterial microbiology/microbiome.
• Biochemical marker and/or drug and metabolite measurement in biofluids.
• Sweat analysis.
• Advanced pulmonary function testing.
• Pulmonary mucociliary clearance.
• Imaging of CF-affected organs and tissues.
• Patient Reported Outcomes (PROs).