CF research centers and people with CF rely on the Therapeutics Development Network’s (TDN) protocol review process to ensure optimum safety and quality in clinical trial protocols.
This twofold process consists of centralized protocol review by network experts from the TDN Protocol Review Committee and the Clinical Research Executive Committee. Review is required for all industry-sponsored CF studies and investigator initiated therapeutic multicenter CF studies that will be conducted within the TDN.
TDN protocol review helps clinical trial sponsors and principal investigators:
- Optimize study design.
- Ensure efficient conduct within the CF center network.
- Protect patient safety.
- Maintain the integrity of study data and specimens.
- See how their studies fit in with the priorities of the CF Foundation.
Our online review process is streamlined for efficiency, and most sponsors find the detailed written feedback they receive to be extremely valuable.
Protocol Review Committee
The TDN Protocol Review Committee (PRC) is a pool of experienced CF physician investigators, research coordinators, biostatisticians, people with CF and other specialists.
PRC members use a standard set of criteria to evaluate each protocol for scientific merit, study design and feasibility. The committee provides a detailed written critique and numerical ratings in each of these categories.
Clinical Research Executive Committee
The Clinical Research Executive Committee (CREC) includes CF Foundation executives, senior CF researchers and TDN Coordinating Center leadership.
This group assesses how the protocol fits with the overall priorities of the CF Foundation for clinical research and assigns an associated numerical rating.
The TDN protocol review process is facilitated by the TDN Coordinating Center.
This process was designed to complement and run parallel to the CFFT Data Safety Monitoring Board (DSMB) protocol review process.
The TDN also partners with the European CF Society Clinical Trials Network for combined review of protocols that will be conducted both in the United States and Europe.
Sponsors will receive the most value from the process if they submit protocols to the TDN in final draft form and prior to site selection, when there is still opportunity to incorporate feedback.
To allow time for contract processing and other administrative setup, sponsors/principal investigators should initiate contact with the TDNCC at least six weeks in advance of a protocol review submission.
Please contact us at TDNCC@seattlechildrens.org to get started.
For More Information
For more detailed information about protocol review, including a sponsor checklist, download the CFFT TDN Protocol Review and Data Safety Monitoring Processes brochure and flow chart.
For assistance with protocol development, see the TDN Consulting Services Program.
Support for study startup and implementation is offered through the TDN Coordinating Center.
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