Periodic Reporting for period 1 - CTCAN (Clinical Trials Community Africa Network)
Reporting period: 2023-05-01 to 2024-10-31
The CTCAN project will lay the foundation for the creation of a coordinated and sustainable umbrella network of clinical trial sites and laboratories capable of undertaking SRA-quality clinical research in SSA.
The objective is to make the network easily accessible and leverage-able by African and international sponsors. CTCAN will build on the existing Clinical Trials Community (CTC) platform, an easy-to-use electronic registry of clinical trial sites in Africa. A clinical trial preparedness framework will provide the necessary tools to assess site and laboratory capabilities and any potential quality and operational gaps they may have, along with the instruments to mitigate and overcome these gaps.
In addition to the European & Developing Countries Clinical Trials Partnership (EDCTP) call-specific objectives, CTCAN will optimally leverage and strengthen other features of the CTC platform that are critically important for effective and efficient trial execution in Africa: demography of diseases-of-interest and patient populations paired with ready-to-use operational information on local and national regulations impacting clinical trial start-up and conduct.
The objective is to make the network easily accessible and leverage-able by African and international sponsors. CTCAN will build on the existing Clinical Trials Community (CTC) platform, an easy-to-use electronic registry of clinical trial sites in Africa. A clinical trial preparedness framework will provide the necessary tools to assess site and laboratory capabilities and any potential quality and operational gaps they may have, along with the instruments to mitigate and overcome these gaps.
In addition to the European & Developing Countries Clinical Trials Partnership (EDCTP) call-specific objectives, CTCAN will optimally leverage and strengthen other features of the CTC platform that are critically important for effective and efficient trial execution in Africa: demography of diseases-of-interest and patient populations paired with ready-to-use operational information on local and national regulations impacting clinical trial start-up and conduct.
Objective 1: Develop an Umbrella SSA Network Consolidating Clinical Trial Sites and Laboratories
Progress: CTCAN network has been established and continues to consolidate and integrate other existing networks with five networks onboarded to date as described under Work Package 2, task 2.2 below. Governance structures such as executive committee and steering committee are fully operational, supporting strategic coordination across work packages. Technical working groups are active and providing expert guidance on several outputs including clinical trial preparedness, epidemiology, and regulatory operations.
Objective 2: Supplement the network with epidemiological data associated with the sites and laboratories, and clear and operationalised regulatory information required for clinical trial start-up and conduct
Progress: Seven key epidemiological data sources have been identified and catalogued in the Epidemiological Data Inventory. Ongoing engagement with data owners for potential collaborations, including DHIS2 custodians in Kenya and South Africa were initiated in Q4, 2024. A regulatory framework has been developed, covering ethics and operational requirements, and is under external validation. Digital regulatory tools have been incorporated into the CTC platform.
Outstanding work: Collaboration with IHME to integrate data into the Global Burden of Disease project faced challenges due to limited funding and data-sharing reluctance. Mitigation strategies included activating WP7 technical working group on Epidemiology to review and align data sources with CTCAN priorities which is currently ongoing.
Objective 3: Develop a Framework to Build Capacity and Increase Clinical Trial Preparedness
Progress: Significant progress has been made towards enhancing clinical trial preparedness under WP5. A Clinical Trial Preparedness Compendium has been developed to guide Clinical Research Centers (CRCs) in adopting ICH-GCP principles, addressing compliance gaps, and ensuring best practices. Feedback from multiple sites has refined its content, and the final version will be published on the CTC platform as scheduled by 30th April 2025. A roadmap for data sharing has also been developed including a playbook for transitioning from paper-based systems to electronic medical records (eMR) and strategies for developing a federated data-sharing network which could allow data sciences and artificial intelligence to improve patient care and research coordination.
Objective 4: Make critical information available through a single electronic platform: the Clinical Trials Community platform
Progress: CTCAN continues to enhance the CTC platform to serve as a centralized hub for clinical trial resources. The intention is not to recreate information already available elsewhere but make links between other accessible data sources. The CTC platform has been enhanced with a banner module linking to regulatory systems in three SSA countries (Tanzania, Nigeria, South Africa).
Progress: CTCAN network has been established and continues to consolidate and integrate other existing networks with five networks onboarded to date as described under Work Package 2, task 2.2 below. Governance structures such as executive committee and steering committee are fully operational, supporting strategic coordination across work packages. Technical working groups are active and providing expert guidance on several outputs including clinical trial preparedness, epidemiology, and regulatory operations.
Objective 2: Supplement the network with epidemiological data associated with the sites and laboratories, and clear and operationalised regulatory information required for clinical trial start-up and conduct
Progress: Seven key epidemiological data sources have been identified and catalogued in the Epidemiological Data Inventory. Ongoing engagement with data owners for potential collaborations, including DHIS2 custodians in Kenya and South Africa were initiated in Q4, 2024. A regulatory framework has been developed, covering ethics and operational requirements, and is under external validation. Digital regulatory tools have been incorporated into the CTC platform.
Outstanding work: Collaboration with IHME to integrate data into the Global Burden of Disease project faced challenges due to limited funding and data-sharing reluctance. Mitigation strategies included activating WP7 technical working group on Epidemiology to review and align data sources with CTCAN priorities which is currently ongoing.
Objective 3: Develop a Framework to Build Capacity and Increase Clinical Trial Preparedness
Progress: Significant progress has been made towards enhancing clinical trial preparedness under WP5. A Clinical Trial Preparedness Compendium has been developed to guide Clinical Research Centers (CRCs) in adopting ICH-GCP principles, addressing compliance gaps, and ensuring best practices. Feedback from multiple sites has refined its content, and the final version will be published on the CTC platform as scheduled by 30th April 2025. A roadmap for data sharing has also been developed including a playbook for transitioning from paper-based systems to electronic medical records (eMR) and strategies for developing a federated data-sharing network which could allow data sciences and artificial intelligence to improve patient care and research coordination.
Objective 4: Make critical information available through a single electronic platform: the Clinical Trials Community platform
Progress: CTCAN continues to enhance the CTC platform to serve as a centralized hub for clinical trial resources. The intention is not to recreate information already available elsewhere but make links between other accessible data sources. The CTC platform has been enhanced with a banner module linking to regulatory systems in three SSA countries (Tanzania, Nigeria, South Africa).
The CTCAN project has made significant strides towards its envisioned scientific impact, aligning with its objectives outlined in annex 1.
Key progress includes:
1. CTCAN network has successfully begun establishing an umbrella network of networks, researchers, and institutions in the region as evidenced by networks that have joined CTCAN since its inception. The creation of an umbrella network is important for collaboration and sharing of knowledge in clinical trials and scientific impact.
2. Through WP outputs, CTCAN has introduced standardized tools and frameworks to streamline clinical trial processes across participating institutions, promoting consistency and reliability in scientific outputs.
3. CTCAN has begun building partnerships with pharmaceutical and other research organizations which is anticipated to catalyse additional funding and investments in local clinical sites.
Key progress includes:
1. CTCAN network has successfully begun establishing an umbrella network of networks, researchers, and institutions in the region as evidenced by networks that have joined CTCAN since its inception. The creation of an umbrella network is important for collaboration and sharing of knowledge in clinical trials and scientific impact.
2. Through WP outputs, CTCAN has introduced standardized tools and frameworks to streamline clinical trial processes across participating institutions, promoting consistency and reliability in scientific outputs.
3. CTCAN has begun building partnerships with pharmaceutical and other research organizations which is anticipated to catalyse additional funding and investments in local clinical sites.