The EDCTP
Knowledge Hub
Johanna Roth and Lara Pandya
EDCTP commissioned The Global Health Network to develop the EDCTP Knowledge Hub. This one-stop open online portal offers tools and guidance for researchers involved in clinical trials, non-interventional studies and product-focused implementation research in low-resource settings. The EDCTP Knowledge Hub aims to become a core resource for guidance on study protocol development, data management and data sharing processes.
The EDCTP Knowledge Hub is hosted on the large knowledge sharing and capacity building platform of The Global Health Network, the operations of which are led by its Director, Professor Trudie Lang. From the Network’s perspective, she commented on the partnership with EDCTP for developing the Knowledge Hub: “We have been delighted to work with EDCTP to develop these tools. We know from our research that the areas of difficulty in running high-quality clinical trials do not largely differ between disease areas or types of study. So, we are able to bring these cross-cutting tools, resources, training and guidance to researchers. We hope that these approaches and access to resources can help them run faster and better clinical trials that result in highly impactful evidence that can be put into practice.”
scroll down
Following the launch of the EDCTP Knowledge Hub in November 2020, two webinars have been organised to present the available tools and elicit feedback. The first webinar took place on 30 November 2020 and focused on data management and data sharing. On 25 February 2021, the second webinar covered the resources on protocol development. Both webinars received high interest and engagement from participants across the globe.
The webinar format consisted of live demonstrations of resources, a panel of speakers providing feedback, and an open conversation about the experiences and issues faced on the various topics. Overall, panel members and participants found the EDCTP Knowledge Hub a good resource containing practical how-to guidance, all conveniently in one place. They are looking forward to seeing it populated with more information and tools.
A clear message on data sharing was put forward, emphasising the need for open science supported by equitable sharing of research data and balancing its benefits. However, its complexities should also be fully acknowledged, including practical challenges, legitimate interests requiring protection, and the need to build public trust.
The recordings of the two webinars, the webinar reports and the question and answer sessions are being collated on the EDCTP Knowledge Hub. A feedback form is also available and suggestions for additions or improvement are highly welcome.
Feedback from experts and users
The EDCTP Knowledge Hub comprises the Protocol Development Toolkit, the Data Management Portal and the Data Sharing Toolkit, collectively a set of tools that takes a researcher from the conception of research question(s) through to reporting results and sharing data.
An essential first step in developing research questions into a well-designed study is protocol development. The Protocol Development Toolkit was designed to support researchers in this process and to provide the tools and guidance to produce a high-quality health research protocol. The toolkit includes extensive step-by-step guidance and access to the SEPTRE software tool for protocol development to support the creation, management and registration of high-quality protocols for clinical trials conducted in resource-limited settings. The toolkit also includes a crowd review option for draft protocols to facilitate their improvement through feedback and advice from the wider research community.
Good data management is critical to ensure the validity and quality of data in all types of clinical research and an essential requirement for successful data sharing. The Data Management Portal was developed to support researchers in ensuring high-quality data management. Data management should be planned for from the outset and throughout the life of a research project.
Data sharing is recognised as a crucial contribution to maximising the knowledge and benefits to be derived from clinical research. In keeping with the approach of the European Union, EDCTP requires its grant holders to share primary clinical data in a useful manner, i.e. to make it possible for third parties to access, mine, exploit, reproduce and disseminate the data generated by the funded research, free of charge. Increasingly, open access data sharing is also required by research publishers, regulatory agencies, ethics committees, and other funding bodies.
Despite these requirements, information about data sharing is difficult to find and researchers report numerous challenges to data sharing. Therefore, simple comprehensive tools to guide researchers through the ‘how, where and when’ of data sharing are needed. The Data Sharing Toolkit offers resources relevant to all stages of data sharing, from data processing and management, through preparation of metadata and documentation, to an online tool to help selecting an appropriate repository for data deposition.
Available resources
scroll down
Johanna Roth and Lara Pandya
The EDCTP
Knowledge Hub
EDCTP commissioned The Global Health Network to develop the EDCTP Knowledge Hub. This one-stop open online portal offers tools and guidance for researchers involved in clinical trials, non-interventional studies and product-focused implementation research in low-resource settings. The EDCTP Knowledge Hub aims to become a core resource for guidance on study protocol development, data management and data sharing processes.
The EDCTP Knowledge Hub is hosted on the large knowledge sharing and capacity building platform of The Global Health Network, the operations of which are led by its Director, Professor Trudie Lang. From the Network’s perspective, she commented on the partnership with EDCTP for developing the Knowledge Hub: “We have been delighted to work with EDCTP to develop these tools. We know from our research that the areas of difficulty in running high-quality clinical trials do not largely differ between disease areas or types of study. So, we are able to bring these cross-cutting tools, resources, training and guidance to researchers. We hope that these approaches and access to resources can help them run faster and better clinical trials that result in highly impactful evidence that can be put into practice.”
The EDCTP Knowledge Hub comprises the Protocol Development Toolkit, the Data Management Portal and the Data Sharing Toolkit, collectively a set of tools that takes a researcher from the conception of research question(s) through to reporting results and sharing data.
An essential first step in developing research questions into a well-designed study is protocol development. The Protocol Development Toolkit was designed to support researchers in this process and to provide the tools and guidance to produce a high-quality health research protocol. The toolkit includes extensive step-by-step guidance and access to the SEPTRE software tool for protocol development to support the creation, management and registration of high-quality protocols for clinical trials conducted in resource-limited settings. The toolkit also includes a crowd review option for draft protocols to facilitate their improvement through feedback and advice from the wider research community.
Good data management is critical to ensure the validity and quality of data in all types of clinical research and an essential requirement for successful data sharing. The Data Management Portal was developed to support researchers in ensuring high-quality data management. Data management should be planned for from the outset and throughout the life of a research project.
Data sharing is recognised as a crucial contribution to maximising the knowledge and benefits to be derived from clinical research. In keeping with the approach of the European Union, EDCTP requires its grant holders to share primary clinical data in a useful manner, i.e. to make it possible for third parties to access, mine, exploit, reproduce and disseminate the data generated by the funded research, free of charge. Increasingly, open access data sharing is also required by research publishers, regulatory agencies, ethics committees, and other funding bodies.
Despite these requirements, information about data sharing is difficult to find and researchers report numerous challenges to data sharing. Therefore, simple comprehensive tools to guide researchers through the ‘how, where and when’ of data sharing are needed. The Data Sharing Toolkit offers resources relevant to all stages of data sharing, from data processing and management, through preparation of metadata and documentation, to an online tool to help selecting an appropriate repository for data deposition.
Available resources
Following the launch of the EDCTP Knowledge Hub in November 2020, two webinars have been organised to present the available tools and elicit feedback. The first webinar took place on 30 November 2020 and focused on data management and data sharing. On 25 February 2021, the second webinar covered the resources on protocol development. Both webinars received high interest and engagement from participants across the globe.
The webinar format consisted of live demonstrations of resources, a panel of speakers providing feedback, and an open conversation about the experiences and issues faced on the various topics. Overall, panel members and participants found the EDCTP Knowledge Hub a good resource containing practical how-to guidance, all conveniently in one place. They are looking forward to seeing it populated with more information and tools.
A clear message on data sharing was put forward, emphasising the need for open science supported by equitable sharing of research data and balancing its benefits. However, its complexities should also be fully acknowledged, including practical challenges, legitimate interests requiring protection, and the need to build public trust.
The recordings of the two webinars, the webinar reports and the question and answer sessions are being collated on the EDCTP Knowledge Hub. A feedback form is also available and suggestions for additions or improvement are highly welcome.
Feedback from experts and users