SUMMARY
ISARIC is seeking two individuals, with the support of their institutions, to partner in the development and delivery of the ISARIC Clinical Characterisation Protocol (CCP). The ISARIC CCP is an observational study framework designed to rapidly characterise the clinical epidemiology and pathogenesis of epidemic prone infectious diseases to inform patient care and public health action. ISARIC provides template study documents, data management, database hosting, analytic tools, global coordination, and operational support to facilitate broad implementation of the CCP. The ISARIC Global Support Centre (GSC) currently oversees all CCP activities on behalf of the ISARIC Executive Board.
The successful partners will work with the ISARIC GSC to extend the number and diversity of institutions with approval and readiness to implement CCP. They will also contribute to the further development of study management tools to support the quality and efficiency of CCP implementation. Funding and support will be provided to the selected institutions and individuals for an initial 2-year period with possibility of extension to mid-2029.
Key Dates:
30 January 2025, 23h GMT: Application submission deadline
February 2025: Discussions with invited institutions
March 2025: Selection and award of funding
Enquiries: Questions or clarifications are welcome at data@isaric.org before 20 January 2025. Questions and answers, if any, will be posted to the online application form web page at https://app.onlinesurveys.jisc.ac.uk/s/oxford/ccp-coordination-partnership-call
BACKGROUND
Since 2012, the CCP has been a cornerstone of ISARIC’s outbreak research preparedness and response. Developed by ISARIC and WHO, the protocol is a standardised framework for the rapid and coordinated clinical investigation of infections of public health interest. It has been implemented for Ebola virus disease, severe acute respiratory illness, Zika, acute encephalitis syndrome, MERS-CoV, mpox, and severe dengue. During the SARS-CoV-2 pandemic, the CCP was used as a collaborative framework across >1,800 international sites to collect and analyse clinical data on ~1,000,000 hospitalised COVID-19 patients and characterise the disease on a global scale.
The benefits of prepositioned, agile, standardised and coordinated clinical research capability are now widely recognised. These include the rapid, collaborative characterisation of emerging infectious diseases to calibrate healthcare and public health interventions, and improved patient outcomes through availability of robust and actionable clinical evidence. The CCP is a tool to build and prepare the capability of health centres to deliver these outputs. ISARIC’s Clinical Epidemiology Platform is available to support CCP data collection, processing and analysis.
The purpose of this call is to identify two individuals who, with the support of their employing institution, will expand CCP implementation and contribute to CCP development to enhance outbreak research readiness and response. By creating a globally dispersed CCP team, we aim to strengthen individual sites, regional and global research partnerships, and the broader clinical research ecosystem.
Read more about the CCP here. Read more about the Clinical Epidemiology Platform here.
ELIGIBILITY REQUIREMENTS
Lead applicants must be part of an ISARIC Member Network. Information on becoming an ISARIC Member is available here.
Lead applicants must have a track record of delivering collaborative research on emerging infectious diseases.
Lead applicants must be employed by the applicant institution, which should be their primary place of work.
Applicant institutions must be registered as a legal entity in a country with a low- or middle-income economy (LMIE, as listed by the Organisation for Economic Co-operation and Development).
Applicant institutions must meet the University of Oxford’s due diligence requirements and execute a research collaboration agreement with the university.
RESPONSIBILITIES AND ACTIVITIES
In collaboration with the ISARIC GSC and each other, the selected institutions will design and implement a strategy for CCP implementation that addresses regional health priorities. The institutions will build skills, tools, and networks to generate, communicate and utilise high quality clinical evidence that reduces the impact of emerging and epidemic prone infectious diseases. The focus of these efforts should be directed towards health and research centres in countries with LMIEs and should enable sustainable outbreak research capacity.
Dependant on the agreed strategy, the institution’s responsibilities and activities may include:
- Contextualising and evolving CCP science. E.g., adapt the CCP protocol, study tools, and outputs to fit local contexts; develop new, locally relevant sub-studies; engage clinical and research stakeholders to contribute new research questions.
- Securing approvals. E.g., obtain and maintain the required ethics and regulatory approvals; execute contracts needed to access data and materials; secure institutional support.
- Ensuring operational readiness. E.g., engage patients and the public to inform study design and delivery, prepare study documents and study management processes; train research staff; ensure data management and analysis systems are in place; support laboratory preparedness.
- Enrolling participants. E.g., directly or indirectly support the recruitment and retention of eligible study participants.
- Coordinating. E.g., track study progress across sites; liaise with ISARIC Global Support Centre and research partners to promote global coordination and impact.
- Ensuring research quality. E.g., develop standard operating procedures for key activities; design and implement quality management approaches.
The institutions will deliver these activities on behalf of the ISARIC network. The institutions will be supported by, and report to, the ISARIC GSC who oversee all CCP activities on behalf of the ISARIC Executive Board.
AVAILABLE FUNDING AND DURATION
Up to £100,000 is available per institution to fund activities over a 2-year period (mid 2025 – mid 2027). Decisions on continuation of funding for an additional 2 years will be made based on the key performance indicators achieved (see below). The funding is expected to support the types of activities outlined above. Funding for data collection and patient care are not included.
DELIVERABLES AND KEY PERFORMANCE INDICATORS
The institutions will report quarterly on activities, progress, and plans. Reports will be aggregated by the ISARIC GSC and communicated regularly to the ISARIC Executive Board. The contents of the reports will be agreed between ISARIC and the institutions. They are likely to detail:
- Number of sites with approval and operational readiness to recruit CCP participants
- Number of participants recruited at each site.
- Data and research quality management activities
- Research capacity strengthening activities
- Use of the ISARIC Clinical Epidemiology Platform for data analysis
- New tools or scientific initiatives implemented as a part of CCP
- Public engagement activities and feedback
- Impact of the project, including but not limited to evidence generated, disseminated, and incorporated into policy decision making (e.g., publications; reports or communications with local health authorities; public health or treatment guidelines that reflect or reference evidence generated)
- Plans for next steps, funding applications, protocol adaptations, and sustainability
APPLICATION PROCESS
Please complete the online form here: https://app.onlinesurveys.jisc.ac.uk/s/oxford/ccp-coordination-partnership-call
Application deadline is 23h GMT on 30 January 2025.
EVALUATION CRITERIA
Up to two applicant institutions will be selected for funding. Selection will be based on the following criteria:
- Leadership: The applicants have a track record of achieving research impact in emerging infections
- Institutional capacity: The institutional context includes resources, infrastructure, and support to deliver the work and manage complex research collaborations
- Strategy: The strategy is relevant to ISARIC’s mission; it is innovative, includes a diverse patient population, and likely to produce actionable evidence that informs policy and practice to deliver significant impact in clinical and public health outcomes
- Research rationale: The proposed research clearly aligns with ISARIC and CCP strategic objectives
- Feasibility: The organisational structure and implementation plan are well designed to realise and sustain relevant outbreak research preparedness, rapid activation of participant recruitment, and strengthened research capacity,
- Engagement: Plans for disseminating results and engaging diverse stakeholders are relevant and robust
- Resource allocation: The proposed use of funds is clear and appropriate to achieve the project goals effectively
