Learn about cystic fibrosis, a genetic disorder that affects the lungs, pancreas, and other organs, and how to treat and live with this chronic disease.
CF is a rare genetic disease found in about 30,000 people in the U.S. If you have CF or are considering testing for it, knowing about the role of genetics in CF can help you make informed decisions about your health care.
If you or your child has just been diagnosed with cystic fibrosis, or your doctor has recommended testing for CF, you may have many questions.
Diagnosing CF is a multistep process. A complete diagnostic evaluation should include a newborn screening, a sweat chloride test, a genetic or carrier test, and a clinical evaluation at a CF Foundation-accredited care center.
Raising a child with cystic fibrosis can bring up many questions because CF affects many aspects of your child’s life. Here you’ll find resources to help you manage your child’s daily needs and find the best possible CF care.
Living with cystic fibrosis comes with many challenges, including medical, social, and financial. By learning more about how you can manage your disease every day, you can ultimately help find a balance between your busy lifestyle and your CF care.
People with CF are living longer, healthier lives than ever before. As an adult with CF, you may reach key milestones you might not have considered. Planning for these life events requires careful thought as you make decisions that may impact your life.
People with cystic fibrosis are living longer and more fulfilling lives, thanks in part to specialized CF care and a range of treatment options.
Cystic Fibrosis Foundation-accredited care centers provide expert care and specialized disease management to people living with cystic fibrosis.
We provide funding for and accredit more than 120 care centers and 53 affiliate programs nationwide. The high quality of specialized care available throughout the care center network has led to the improved length and quality of life for people with CF.
The Cystic Fibrosis Foundation provides standard care guidelines based on the latest research, medical evidence, and consultation with experts on best practices.
As a clinician, you’re critical in helping people with CF maintain their quality of life. We’re committed to helping you partner with patients and their families by providing resources you can use to improve and continue to provide high-quality care.
As part of the Cystic Fibrosis Foundation's mission to help improve the lives of people living with cystic fibrosis, the PSDC initiative taps the CF community to inform key efforts to support the management of daily care.
Your cystic fibrosis care team includes a group of CF health care professionals who partner with you to provide specialized, comprehensive CF care.
Many people living with cystic fibrosis and their families face complicated issues related to getting the care they need. Cystic Fibrosis Foundation Compass makes sure that no one has to do it alone.
CF Foundation Compass is a service that helps people with CF and their families with navigating insurance options, connecting to legal information and experts, finding available financial resources, and tackling other life issues.
CF care team members are paramount in providing highly specialized care to people living with CF. CF Foundation Compass can help by serving as a strategic ally for care teams, so team members can focus on their patients’ care.
CF Foundation Compass can help you navigate insurance, financial, legal, and other issues you are facing. Use this online form to start your conversation with a Compass case manager today.
The Cystic Fibrosis Foundation is the world’s leader in the search for a cure for CF and supports a broad range of research initiatives to tackle the disease from all angles.
The CF Foundation offers a number of resources for learning about clinical trials and treatments that are being developed to improve the treatment of cystic fibrosis.
Our understanding of CF continues to evolve as scientists study what causes the disease and how it affects the body. These insights drive the development of new and better treatments and bring us one step closer to a cure.
Researchers, supported by the CF Foundation, have made tremendous advances to improve the health and quality of life of people with CF. We are committed to providing the tools and resources you need to continuously build upon this work.
The Therapeutics Development Network's (TDN) Protocol Review Process ensures optimum safety and quality in cystic fibrosis clinical trial protocols.
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, and epithelial sodium channel (ENaC) inhibitors. Information about the compound evaluation process for each of these classes can be found by clicking on the links below.
CFTR Modulator Compound Review
Anti-Inflammatory Compound Review
ENaC Inhibitor Compound Review
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:
This online review process is streamlined for efficiency, and most sponsors find the detailed written feedback they receive to be extremely valuable.
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.
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.
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.
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 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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