Clinical Core Services
The specific objectives of the Clinical Core are as follows:
Provide preclinical support for novel therapeutics
The specific aims of the preclinical support services are:
- Develop mechanisms for preclinical review and consulting in order to promote the development and/or commercialization of promising translational research programs, and
- Provide detailed assistance with the development of regulatory strategies and submissions to the Food and Drug Administration (FDA) for clinical development.
The specific aims of the clinical protocol and implementation support services are:
- Provide detailed assistance with the development of the clinical research plans of promising therapeutics for phase 1 and proof of concept phase 2 human clinical trials that would meet all FDA requirements, and
- Provide detailed assistance with the implementation of these research plans and support investigators in moving promising therapeutics into phase 1 and proof of concept phase 2 human clinical trials that would support an FDA approved clinical development plan and eventual approval for patients with cystic fibrosis.
The specific aims of the biorepository support services are to:
- Create a biospecimen discovery portal for identification of CF samples (human and bacterial) that are available for research within the Seattle consortium, and
- Create a specimen requisition process that will permit investigators to request specific specimen types from the repository or for prospective acquisition.
The specific aims of the developmental research and training support services are to:
- Develop novel outcome measures for translational research and efficient biostatistical approaches to inform translational study designs, and
- Develop a robust clinical research training program for CF translational investigators including dissemination of "tool kits" for study development and implementation.