Northwestern Cystic Fibrosis Success with Therapies Research Consortium

Project: Research project

Description

Cystic Fibrosis Foundation (CFF) is creating a Success with Therapies Research Consortium for the purpose of identifying and studying interventions to enhance successful self-management and related health outcomes among individuals with CF. It invites applications from accredited Cystic Fibrosis (CF) care programs to participate in this consortium.

Scope of Consortium

This consortium will conduct multi-center efficacy and effectiveness adherence intervention studies. From inception, studies will be designed with sustainability in mind to ensure a product(s) that will be integrated into clinical care and daily life as well as regularly used. Therefore, some protocols may involve interventions conducted in the clinical setting by clinical staff. Studies evaluating the reliability and validity of adherence–related measures will also be conducted within this consortium. Developing a common set of metrics and endpoints is critical to evaluate the efficacy of interventions, as they will allow the direct comparison of benefits and costs across all studies. The consortium will work with other CFF/CFFT committees/initiatives, including the CER/Registry Committee, the Clinical Research Committee, QI initiative and the TDN-CC as necessary.

Consortium Membership

The consortium will be comprised of pediatric, adult, and affiliate CF care programs, diverse in size and representative of all regions of the country. Participating pediatric and adult care programs need not be from the same care center. All programs must be part of CFF-accredited clinical care centers.

The group will work collaboratively under the guidance of co-chairs, Drs. Gregory Sawicki, Boston Children’s Hospital and Kristin Riekert, Johns Hopkins University, to collaboratively identify, prioritize, develop, and test adherence interventions, as well as, to accelerate the process of disseminating, implementing, and sustaining them in the CF community. All consortium members must agree to designate a faculty member as lead Principal Investigator (PI) with administrative responsibilities that include the following:

• Conduct adherence research studies in the clinic setting including providing appropriate personnel, facilities, equipment, materials, services and access to research subjects necessary to complete the investigations
• Foster care team physician support for adherence research
• Identify trained and dedicated clinical research staff
• Identify engaged clinical staff who will implement interventions in the clinic setting
• Participate in a collaborative manner to further the goal of the consortium
• Attend consortium meetings, calls and training sessions
• Participate in working groups and the development of new protocols for the consortium
• Provide regular updates on study team changes, site capabilities and study participation
• Be responsive to requests for information from the CFF or study management organization
• Obtain institutional commitment to facilitate the contract process
• Submit an annual progress report
StatusActive
Effective start/end date8/1/147/31/20

Funding

  • Cystic Fibrosis Foundation Therapeutics, Inc. (PRICKE14PE0)

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Cystic Fibrosis
Research
Therapeutics
Pediatrics
Research Subjects
Annual Reports
Self Care
Contracts
Reproducibility of Results
Cost-Benefit Analysis
Registries
Research Personnel
Physicians
Equipment and Supplies
Health