ISARIC H5Nx Research Response Guidance

ISARIC has partnered with global experts to adapt its Clinical Epidemiology Platform, enabling research on the clinical characteristics of H5Nx to guide patient care and inform health policy. Dedicated to enhancing evidence generation, ISARIC provides tools and support for research teams to quickly set up studies that address the research questions in their context and inform clinical trial design. The platform is also available for collaborative analyses that can characterise H5Nx across different variants, countries, and over time.

The ISARIC-WHO Clinical Characterisation Protocol and the ISARIC Clinical Epidemiology Platform is a suite of openly-available, standardised tools to support your research and facilitate global collaboration. Tools within this platform will help you to create a Case Report Form (CRF), launch a database, and perform statistical analysis on the data you collect.

Here are the steps to set up your H5Nx study:

STEP 1: Prepare your protocol and study documents

The ISARIC-WHO Clinical Characterisation Protocol (CCP) provides a standardised method for the rapid, coordinated clinical investigation of emerging health threats.

This protocol can be adapted for H5Nx to inform clinical care, public health response, and clinical trial design. Researchers may add additional research questions, customise the procedures to their sites, and alter the investigations according to their priorities and available resources.

Be sure to secure the ethics and regulatory approvals required for your study.

Links:

STEP 2: Create a Case Report Form (CRF)

ISARIC and partners have developed a standardised case report form (CRF) for H5Nx. The form includes the variables needed to efficiently characterise the natural history of H5Nx across variants, regions, time and populations. It is structured to quickly identify risk factors for severe outcomes, understand the mechanisms of disease, and provide key evidence to inform the design of clinical trials.

You can use the ISARIC H5Nx CRF as designed, or tailor it to your context by adding or removing variables using our BRIDGE tool.

Links:

STEP 3: Set up a database for data capture

After using BRIDGE to select your final CRF, BRIDGE will generate a download of the CRF and create a CRF completion guide. It will also generate an XML file and data dictionary to set up a REDCap database that matches your CRF.

If your institution uses REDCap, upload the XML file and data dictionary to a REDCap project to launch a database for your study.

If your institution does not currently host REDCap software, but would like to, you can find installation instructions and technical requirements on the REDCap home page. The data dictionary can also be used to design a database in any other data management software you prefer.

ISARIC has a H5Nx REDCap database available for use by any sites that decide not to run their own data management software. Support and hosting are provided by ISARIC.

Please contact data@isaric.org for support, to launch a database, host data, map to the ISARIC data model, or anything else we can assist with.

Links:

STEP 4: Analyse your data

For an example Statistical Analysis Plan (SAP), please see the ISARIC mpox SAP, which was developed to align with the CCP and an ISARIC mpox CRF. This SAP is currently specific to mpox but it can be adapted for H5Nx studies instead of mpox, tailored to your needs and used for data analysis.

ISARIC also provides a set of analytic tools called VERTEX, designed to perform the analyses outlined in the SAP using ISARIC's data structures. VERTEX generates tables and visualisations using Python code, and displays this information for each relevant research question or study endpoint, in a web application dashboard.

VERTEX is built using reproducible analytical pipelines. It is designed to allow ISARIC partners and the broader scientific community to develop, contribute to, and share their own analytic codes so that other researchers can use and reproduce them.

Links:

For more information or support, contact ISARIC's Global Support Centre at the Pandemic Sciences Institute, University of Oxford: data@isaric.org.