Therapeutics Development Network (TDN) investigators and research staff work every day to promote quality, safety and efficiency in CF clinical research and help speed the delivery of new and better therapies to people with CF.
After 16 years conducting CF clinical trials, we have developed not only individual expertise, but also a well-established infrastructure with specialized tools, standardized processes and centralized services.
Collaborating with the TDN gives investigators and sponsors access to resources that will help them ensure efficient study design, optimize clinical trial execution and obtain the highest-quality data for their CF clinical trials.
We look forward to working together in our efforts to improve the lives of people with cystic fibrosis.
Leveraging Network Expertise
Since its inception in 1998, the TDN has conducted more than 100 clinical studies for CF in a wide range of therapeutic areas, including CFTR modulation, anti-inflammatory therapies, anti-infective therapies, enzyme replacement and ion channel modulation.
As a result, network members have developed significant expertise in the design, implementation and analysis of CF studies. Sponsors and investigators can leverage this expertise for their clinical research programs by:
Centralized Protocol Review and Safety Monitoring
The TDN protocol review process provides sponsors and principal investigators with detailed feedback on their protocols and a sense of how each study fits with the research priorities of the CF Foundation. All industry-sponsored studies and multicenter interventional studies that will be conducted at TDN sites are expected to go through this review process.
Additionally, the CF Foundation expects safety monitoring for all CF multicenter studies to be conducted by the CFFT Data Safety Monitoring Board.
CF Therapeutics Development Centers and other CF researchers rely on these steps to help ensure CF protocols are of the highest quality and in the best interests of people with CF.
Study Site Solicitation
The TDN Coordinating Center (TDNCC) can help identify possible study sites by notifying CF Therapeutics Development Centers of the upcoming study and providing the sponsor with a contact list for the centers who express interest.
Having the TDNCC send study solicitation emails assures research centers that the sponsor is working within the TDN system and may result in more timely responses.
This is a complimentary service for sponsors who participate in the TDN protocol review process. Additional support with site selection can also be arranged.
Site Facilities Information
The TDN maintains a database of information regarding the current research facilities of our CF Therapeutics Development Centers. This includes most of the generic information that is typically collected as part of study feasibility questionnaires, such as patient population and Institutional Review Board (IRB) review schedules.
Using our pre-collected information about site capabilities minimizes redundant efforts for both the sponsor and the clinical sites, which can help facilitate faster site selection.
Port CF Clinical Trial Query Tool
CF Foundation-accredited care centers maintain key patient data in a common database called Port CF. For most studies, the Foundation is able to load a high-level query into Port CF to help center staff do an initial screen for the number of people at their center who might be eligible for the study.
This service is available upon request and at no charge for study sponsors who participate in the TDN protocol review process.
To learn more about conducting a study with the TDN or how we can best support you, please contact us at firstname.lastname@example.org.
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