ISARIC’s Process, Tasks, and Services
 
EDCTP call: Research and clinical management of patients in PRD epidemics in sub-Saharan Africa
 
BACKGROUND
The recently launched EDCTP call Research and Clinical Management of Patients with PRD epidemics in sub-Saharan Africa encourages applicants to work with national, regional, and international initiatives such as ISARIC and PREPARE Europe. Successful applications will have gone through a two-stage process, with a letter of intent due in the end of September, and invited applicants have two months to submit a full application in the beginning of 2017. The call would provide one successful applicant €10M for three to five years. Please find further details about the call here.
 
ISARIC’S INVOLVEMENT AND PROPOSED PROCESS
ISARIC needs to have a process in place to deal with any requests or queries from applicants to this call, especially as we are asked to collaborate with the successful applicant. The process needs to address how we best approach emailed queries, invitations to join multiple consortia, and whether our Partnership Policy is fit for purpose and, if so, whether it is applicable to this situation. ISARIC will also need to consider which services and tasks that the Coordinating Centre could offer to competing consortia, and the budget for each specified task and service.
 
ISARIC’s Executive Committee has decided that ISARIC should be willing and able to participate in multiple competing applications, and that ISARIC, as a consortium and/or its Coordinating Centre, should not offer exclusivity to any one applicant. In order to take collaboration further, ISARIC’s Executive Committee has set up an EDCTP-ISARIC Review Committee that will conduct an internal review of applications that are proposed for ISARIC endorsement. Successful proposals will be endorsed as ‘ISARIC Partnership Initiatives’, on the basis of a majority vote of the ISARIC Executive Committee (with any conflicted members of the Executive recused) – within one month of submission for review. However, protocols with urgent timelines will be considered on an expedited basis.
 
For review activities, or should consortia otherwise seek advice and support from ISARIC, members of the ISARIC governance structure who are potentially conflicted (e.g. participating in competing bids) will be excluded from the review and advice process.
 
Should applicants utilise the tasks or services outlined below, and for the sustainability of the ISARIC Coordinating Centre, it is expected that ISARIC Partnership Initiatives consider the financial provisions accordingly. In addition to specific tasks and services, consortia that seeks to be labelled ISARIC Partnership Initiatives would need to include budget lines that cover any expenses incurred by ISARIC’s participation, such as related infrastructure costs at ISARIC’s Coordinating Centre.
 
All applicants that wish to seek endorsement as ISARIC Partnership Initiatives should contact the ISARIC Coordinating Centre by email: gail.carson@ndm.ox.ac.uk to initiate the process, by 15 September at the latest. However, should consortia suggest tasks and services that go beyond the tasks and services suggested below, contact should be made ASAP to ensure appropriate review and consideration.
 
Please note that the review process outlined here is internal to ISARIC, and that it by no means seek to replicate or overlap with EDCTP's review processes for submitted proposals.
 
ISARIC TASKS AND SERVICES
 
I. Communication and global collaboration
 
ISARIC is very well positioned to facilitate collaboration and coordination between different regional preparedness initiatives, with links to PREPARE, ASPIRE, and a developing Zika preparedness platform in Latin America and the Caribbean that will ensure clinical research preparedness ahead of future infectious disease outbreaks in the region. ISARIC has a broad membership that spans over 110 different countries globally and across a spectrum of resource settings. ISARIC brings together clinicians, clinical researchers, public health, epidemiologists, virologists, microbiologists, statisticians, ethicists, and clinical trialists. This multi-disciplinary network is well positioned to provide further links that would be useful to the successful applicants. ISARIC offers a neutral platform that enables key stakeholders to interact, exchange information, and develop partnerships during outbreaks. An example being a series of teleconference calls between clinicians, clinical researchers, public health organisations, and industrial partners during the West African EBOV outbreak. Similar efforts are currently ongoing for the Zika outbreak.
 
II. Standardization and the development of research tools
 
We have developed generic tools that are available for adaptation by interested investigators (e.g. research protocols, CRFs and other supporting documentation for data capture. In response to a number of recent outbreaks, such as EBOV, MERS-CoV, avian influenza H7N9, and ZIKV, the ISARIC Coordinating Centre has, in collaboration with other partners, already adapted these tools to make them more specific, avoid duplication and save time.ISARIC is working closely with WHO and other partners, such as CONSISE, PREPARE Europe, REACTing and IDAMS, to enable the standardisation and harmonisation of tools that are developed – which, in turn, will help to encourage data sharing and comprehensive data sets, which can be compared across studies. The adapted IDAMS Dengue protocol has become the Clinical Characterisation Protocol for ZIKV and is about to undergo review by the WHO Ethical Review Board. It is recognised as one of the harmonised protocols for ZIKV data capture.
 
III. Establishing, testing, and auditing preparedness
 
Having set up ISARIC as a network of networks that aims to provide preparedness for future infectious disease outbreaks globally, ISARIC is well suited to take on tasks related to both establish and test preparedness nationally, regionally, and globally. Tasks under this headline could include the development of processes related to preparedness, including the drafting of Response Plans and other relevant Operational Plans. We would also be able to test preparedness through simulation exercises, ahead of outbreaks. ISARIC would also be able to provide audits to evaluate preparedness and ongoing response efforts. We have already run numerous surveys and operational research efforts in relation to, for instance, the barriers to rapid outbreak responses and the capacity and capability among clinical research networks to produce research responses to outbreaks, which can be used for planning.
 
Download this statement as a PDF here.
Please find ISARIC's Partnership documents here.
 
ISARIC-EDCTP Review Committee:
Roberto Bruzzone, Institut Pasteur & ISARIC Vice Chair
Gail Carson, ISARIC's Coordinating Centre
Kajsa-Stina Longuere, ISARIC's Coordinating Centre
Calum Semple, FLU-CIN & Chair, ISARIC's Working Group 2
Steve Webb, ANZICS CTG & Chair, ISARIC's Working Group 4

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