Leveraging Network Expertise

Since 1998, the Therapeutics Development Network (TDN) has been conducting cystic fibrosis clinical trials and has 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.

Since its inception, the TDN has conducted more than 130 clinical studies for CF in a wide range of therapeutic areas, including restoring CFTR function, mucociliary clearance, anti-inflammatory, anti-infective, and nutrition-gastrointestinal.

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:

• Participating in the TDN protocol review process and safety monitoring
• Engaging with us early on clinical development plans and study design
• Taking advantage of study support offered by the Coordinating Center

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 Cystic Fibrosis Foundation. All industry-sponsored studies and multi-center interventional studies that will be conducted at TDN sites are expected to go through this review process. All studies that are accepted for conduct in the TDN will be added to the Clinical Trial Finder to facilitate recruitment of people with CF.

Additionally, the CF Foundation expects safety monitoring for all CF multicenter studies to be conducted by the 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.

Contact Us

To learn more about conducting a study with the TDN or how we can best support you, please email us at TDNCC@seattlechildrens.org.