Resources

MESH Engagement with Vaccine Studies

Following a Mesh workshop exploring public and community engagement with vaccine studies held in autumn 2020 this resource area was created. Each of the four workshop sessions had a loose overarching theme chosen to enable participants to unpack some of the complex issues surrounding engaging communities with vaccine research and development. Under each theme below we share projects, thoughts from participants and ways of supporting impactful engagement activities.

WHO Coronavirus disease (COVID-2019) R&D Blueprint

The R&D Blueprint is a global strategy and preparedness plan that allows the rapid activation of R&D activities during epidemics. Its aim is to fast-track the availability of effective tests, vaccines and medicines that can be used to save lives and avert large scale crisis.

Meeting report of an expert consultation on the use of placebo in vaccine trials, held in 2013. It considers the major ethical issues and makes recommendations accordingly.

International Clinical Trials Registry Platform

The main aim of the WHO ICTRP is to facilitate the prospective registration of the WHO Trial Registration Data Set on all clinical trials, and to allow the public accessibility of that information.

Database of publications on coronavirus disease (COVID-19)

The WHO is gathering the latest scientific findings and knowledge on coronavirus disease (COVID-19) and compiling it in a database. The database is updated daily from searches of bibliographic databases, hand searches of the table of contents of relevant journals, and the addition of other relevant scientific articles.

Immunization as an essential health service

Guiding principles for immunization activities during the COVID-19 pandemic and other times of severe disruption, which provides support to countries in their decision-making regarding provision or resumption of immuunization services during events such as COVID-19, natural disasters or humanitarian emergencies.

UK Vaccine R&D Network - Vaccine Development Process Map

These two process maps were developed by the UK Vaccine R&D Network, to show key stages in both human vaccine development and veterinary vaccine development up to Phase III clinical trials or veterinary field trials. See also:

The Clinical Data Interchange Standards Consortium (CDISC) has developed this freely available Interim User Guide for studies pertaining to COVID-19. The User Guide provides examples and guidance on implementing CDISC standards for COVID-19 so that users can collect, structure and analyze data more effectively. The User Guide was rapidly developed by a task force of several CDISC member organizations and partners.

Veridata EDC

On 26/03/2020, Elsevier launched Veridata EDC, a secure, compliant and user-friendly platform to capture patient data for clinical research. To assist researchers working to develop vaccines and other therapies for COVID-19, Elsevier has pledged to make Veridata EDC available for free. Interested clinical researchers can contact Elsevier customer support via e-mail at covid19@elsevier.com and apply for a demo account. Following the necessary compliance training, you will receive a free 12-month license.

Press Release

CDC Taps The Task Force’s Expertise to Roll Out COVID-19 Vaccine in up to 50 Countriesà https://taskforce.org/press-release-cdc-taps-the-task-forces-expertise-to-roll-out-covid-19-vaccine-in-up-to-50-countries/

The Centers for Disease Control and Prevention (CDC) has invested in The Task Force for Global Health (TFGH)  to help low and middle income counties with COVID-19 immunization programs. 

Read more.

Webinar titled "Model-informed Drug Repurposing - Applications for COVID-19" with our colleagues at Certara

Hosted by Adeniyi Olagunju, the importance of integrating clinical pharmacology and translational medicine principles in COVID-19 dosing strategy and study design was covered. Following this, Michael Dodds, Samer Mouksassi and Yuan Xiong from Certara demonstrated the pharmacokinetic pharmacodynamic (PKPD) simulation tools available on covidpharmacology.com using recently completed analyses for ivermectin, chloroquine, and lopinavir/ritonavir.

Webinar Video | Webinar Slides

Tools

EDCTP Knowledge Hub

This hub aims to facilitate and provide guidance on several topics related to clinical trials, with resources including a Protocol Development Toolkit, a Data Management Portal and a Data Sharing Toolkit.

The Trial Protocol Tool

This tool packages a wide range of practical information about managing trials in low and middle-income countries into a single software tool. Available in English and Spanish. 

Global Health Trials' Tools and Templates Library

These templates have been shared by other groups, and are free to use and adapt for your research studies. Please ensure that you read and adapt them carefully for your own setting.

Training