With extensive experience in planning and conducting cystic fibrosis clinical research, the Therapeutics Development Network Coordinating Center (TDNCC) engages with industry sponsors to provide protocol development expertise. This early collaboration and advisement provides support for sponsors prior to the submission of their study protocols to the TDN Scientific Review process.
How It Works
The TDNCC encourages sponsors to reach out prior to submitting a protocol for formal TDN Scientific Review. This allows the team to provide advice on how to optimize development plans and study designs so that they are well positioned for conduct in the network.
Getting Started
If you would like to connect with the TDNCC, please email TDNCC@seattlechildrens.org.
Related Information
The TDNCC also leads and provides scientific study support for CF clinical studies, including overall study management, site monitoring, data management, and biostatistics. The CF Foundation and the CF Therapeutics Development Network have created a position paper addressing trial design strategies for nucleic acid-based therapy programs, as well as a letter highlighting guidance for research bronchoscopy in CF clinical trials of mRNA:lipid nanoparticles.
Additionally, the TDNCC encourages study sponsors to engage the CF community in their research.