A recent webinar from the AAS — “Strengthening the African clinical trials regulatory and ethics environment” — focused on fostering communication and ideas to encourage research and collaboration on the continent. Participants included representatives of the AAS, Bill & Melinda Gates Foundation, World Health Organization (WHO) Regional Office for Africa, Novartis and FHI Clinical (Ghiorghis Belai, Vice President of Global Strategy). We were honored to be part of this important discussion about extending research to areas where FHI 360/FHI Clinical has worked for decades.
Themes: Harmonization, communication and transparency
During the panel discussion, the following themes emerged:
- Harmonization and centralization of standards and processes
- Improved communication about and access to regulatory and ethics processes and timelines
Supporting these themes, polls of the attendees highlighted that greater access to information and greater use of technology could improve regulatory and ethics/institutional review board (IRB) processes.
Harmonization and centralization of standards and processes
The number of clinical trials conducted on the continent has increased over the last 10-15 years, but to varying degrees across the individual countries. Differences in expectations and ability to support research at the country level create challenges for sponsors and CROs
Strong regulatory systems are important to both mitigate risk and protect the population while also encouraging innovation. Partnerships between and within countries on the continent and worldwide are necessary to fill the gaps in infrastructure and expertise to conduct trials in an efficient, predictable manner. Greater engagement and collaboration of African countries could extend the domestic capabilities to support early- to late-stage research.
Improved communication about and access to regulatory and ethics processes and timelines
Clarity and predictability of timelines and processes are of primary importance – more so than short timelines. With clear expectations up front, CROs or sponsors can accommodate variations in their planning process. For example, countries and sites with shorter review and approval processes can be onboarded sooner, while those with longer processes can be among the last to begin.
While much discussion has focused on regulatory processes, ethics processes are equally important, and the two are interwoven. For example, if a protocol amendment needs to be signed off by the ethics committees at all sites, the delay at one site can delay the whole program — preventing database lock, submission, approval, registration, etc. For this purpose, central IRBs are viewed favorably by sponsors/CROs because they limit the number of IRBs that need to review applications and subsequent amendments.
Extending the reach to more sites
Improved transparency and more consistent processes would extend the reach beyond a few “go-to” sites with which sponsors and CROs have had success previously. Unclear or poorly documented procedural and timeline information represents missed opportunities for sites and countries seeking to attract clinical trials.
According to Belai, sites can facilitate review of site feasibility by providing the following:
- General capabilities statements (e.g., laboratories, equipment)
- Information about the catchment area (patients served, epidemiological data for the communities served)
- Description of the standard of care for specific diseases (particularly important when standard of care is the comparator)
- Clear contact information for someone at the site
Clinical Trials Community platform
To address some of these concerns, the an AAS project team developed the Clinical Trials Community platform. It aims to centralize standards and processes, increase the visibility of African clinical trialists and research sites and make individual country regulatory and ethics procedures transparent and accessible. The project team received funding from the Bill & Melinda Gates Foundation, with the goal of increasing the level of clinical trial investments in Africa.
In its initial release, the platform integrates data from:
- United States National Institutes of Health (NIH)
- Institute for Health Metrics and Evaluation (IHME)
- Coalition for Epidemic Preparedness Innovations (CEPI)
- Pan-African Clinical Trials Registry (PACTR)
Dashboards include information for clinical sites and national regulators, with the ability to compare information between entities, including timelines and cost. Networking capabilities and training are among future platform enhancements.