TDN Protocol Review Process

The Therapeutics Development Network's (TDN) Protocol Review Process ensures optimum safety and quality in cystic fibrosis clinical trial protocols.

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Summary
  • Independent experts evaluate new potential agents to ensure that there is a likelihood they will have a strong positive clinical impact compared to other candidate compounds in the same therapeutic class.
  • These evaluations are being performed for the following therapeutic classes: CFTR modulators, anti-inflammatory agents, epithelial sodium channel inhibitors, and genetic therapies.
  • The TDN protocol review helps clinical trial sponsors and principal investigators in several ways, including: by optimizing study design, ensuring efficient conduct within the cystic fibrosis center network, and understanding how their studies fit with the priorities of the CF community and the Cystic Fibrosis Foundation.

Compound Review

The mission of the Cystic Fibrosis Foundation -- to cure CF and provide all individuals with the disease the opportunity to lead healthy and fulfilling lives -- has resulted in the development of new CF therapies that attack the disease from every angle.

Concurrent development of multiple candidate agents within a single therapeutic class has also led to real concerns that the availability of individuals with CF to participate in clinical trials may become a limiting factor for optimal, balanced drug development.

To address this concern, the Therapeutics Development Network (TDN) has implemented an early step in the evaluation of new potential agents for therapeutic classes in which different candidate compounds are being brought forward to the clinic.

The goal of this evaluation is to independently assess the preclinical biological characteristics of a compound to better predict the likelihood of it having a strong positive clinical impact. Ideally, this review will occur prior to submission of a sponsor's first clinical trial protocol of that agent. The review is conducted by independent, therapeutic class experts.

Therapeutic classes for which this evaluation is being performed currently include CFTR modulators, anti-inflammatory agents, epithelial sodium channel (ENaC) inhibitors, and genetic therapies. Information about the compound evaluation process for each of the first three classes can be found by clicking on the links below. For more information on the genetic therapies compound evaluation process, please contact TDNCC@seattlechildrens.org.

CFTR Modulator Compound Review

Anti-Inflammatory Compound Review

ENaC Inhibitor Compound Review

Protocol Review Process

CF research centers and individuals with CF rely on the TDN's protocol review process to ensure optimum safety and quality in clinical trial protocols.

This twofold process consists of a 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.

The TDN protocol review helps clinical trial sponsors and principal investigators:

  • Optimize study design
  • Ensure efficient conduct within the CF center network
  • Address and maximize patient safety
  • Maintain the integrity of study data and specimens
  • Understand how their studies fit with the priorities of the CF community and the CF Foundation

This 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 made up of 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 within the categories of 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 senior CF researchers and members of the TDN Coordinating Center and CF Foundation leadership teams.

This group assesses how a specific protocol fits within the overall clinical research priorities of the CF community and assigns it an associated rating.

Review Coordination

The TDN protocol review process is facilitated by TDN Coordinating Center Study Support.

This process was designed to complement and run parallel to the 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 in both the United States and Europe.

Getting Started

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 TDN Coordinating Center 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 CF Foundation TDN Protocol Review and Data Safety Monitoring Processes brochure and flow chart.

For assistance with protocol development, see TDN Sponsor Engagement.

Support for study startup and implementation is offered through the TDN Coordinating Center Study Services.

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Downloads
CFTR Modulator Compound Review Download (PDF)
Anti-Inflammatory Compound Review Download (PDF)
ENaC Inhibitor Compound Review Download (PDF)
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