Table 5.

CRN 5-phase plan, key team members, operational plan, financial projections, and implementation plan.

  1. Strategic plan: The strategic plan will unfold in 5 phases:

    • Phase 1: Identify funding sources initially to support pilot collaborative studies before more longterm funding support is secured and establish the overall structure and leadership of the CRN.

    • Phase 2: Develop SOP and an infrastructure plan for data collection and storage. Address international barriers that inhibit or hinder collaboration and the sharing of data.

    • Phase 3: Decide the major areas that the CRN will focus on. Three areas were identified at the meeting in the July 2017 GRAPPA-CRN meeting in Amsterdam, the Netherlands.

    • Phase 4: Decide how the research effort will be applied: observational studies, clinical trial, data collection for a registry, etc.

    • Phase 5: Begin data collection. To develop and test SOP at the various centers and establish the recruitment and data collection protocols, it may be advisable to start the process at only a few centers with experience in patient recruitment, sample preparation, and the storage and collection of patient-related data. Once the SOP and data collection processes are established and sample storage is deemed satisfactory, the network would be expanded.

  2. Team

    • GRAPPA Research Committee Members and other key people: C. Ritchlin, O. FitzGerald, D. Jadon, A.W. Armstrong, K. Callis Duffin, V. Chandran, D.D. Gladman, S. Pennington, C. Stober, M. de Witt (PRP), and D. O’Sullivan (PRP). We will also engage biopharmaceutical companies in this collaborative effort.

  3. Operational plan

    • Move forward with IMI and establish a license for GRAPPA in the United Kingdom and the European Union.

    • Pursue other funding sources: NIH, AMP, private foundations, and philanthropic contributions.

    • Decide on a nucleus of centers to participate in the initial phase of the CRN.

    • Establish a leadership team and governance structure.

    • Formalize and validate SOP.

    • Establish infrastructure for the collection of data (location, software and database, personnel, etc.).

    • Generate and obtain agreement for operations policies regarding data collection and sharing, publications, and other governance issues.

    • Begin data collection and storage.

  4. Financial projections

    • Items to discuss include projected costs. The cost to support AMP is about US$40 million, to cover 2 diseases over 5 yrs. We will need about $10 million to get started, and that is with a limited number of sites. This type of support will require a substantial commitment over time. In the IPART Registry, each patient entered into the registry and followed for 2 yrs costs about CA$ 4800, so this number will help with projections. Of course, these estimates may not directly apply to the CRN depending on the depth and scope of sample collection proposed. We will also have to estimate how many full-time staff will be required and how much support, if any, we can provide to the sites for coordinators and sample collection and storage.

  5. Knowledge transfer, dissemination, and implementation

    • A committee will be established to address these 3 critical areas comprising physicians, physician scientists, methodologists, and PRP. The CRN will hold standalone meetings and provide updates at the annual GRAPPA meeting and as part of GRAPPA updates at international dermatology and rheumatology meetings. A Website will be created that is accessible by all members of the CRN, which will contain validated SOP, recent manuscripts and presentations, and updated information on the number of samples collected in the network.

  • CRN: Collaborative Research Network; SOP: standard operating procedures; GRAPPA: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis; PRP: patient research partner; IMI: Innovative Medicines Initiatives; US NIH: National Institutes of Health; AMP: Accelerating Medicines Partnership; IPART: International Psoriasis and Arthritis Research Team.