Since the Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines were authorized for emergency use by the US FDA, millions of people in the United States have been vaccinated. However, finding reputable and high-quality sites for new Covid-19 vaccine and drug clinical trials can be a significant challenge. As the COVID-19 vaccine becomes more widely available in the West, new trials are facing challenges in meeting their enrolment targets. As a result, more clinical trials are being shifted to the global south, with sponsors determined to meet ambitious development timelines looking towards internal sites, including Africa.
The traditional pre-COVID-19 approaches to clinical site assessment are not keeping up with the increase in Covid-19 trial complexities observed across the industry. Additionally, the COVID-19 pandemic has introduced unique challenges at clinical sites and highlighted new barriers to performance at previously high-performing international sites. This has made site selection for Covid-19 clinical trials a more difficult task.
In this article, we will highlight five (5) key considerations that sponsors and CROs should assess during site selection for COVID-19 clinical trials in Africa.
1. Political Environment
The COVID-19 pandemic has significantly increased political interference in public health science. In order to ensure success in selecting a country for the COVID-19 vaccine or drug, sponsors must first establish whether there is political support for COVID-19 research at the government level. Additionally, it is important for sponsors and CROs to have a clear understanding of the sensitivities surrounding COVID-19 vaccines and/or clinical trials. This will help to ensure that the clinical trial process is successful.
2. COVID-19 Epidemiology
As a response to the COVID-19 pandemic, many African countries have imposed travel restrictions based on situational reports. Therefore, sponsors and CROs must clearly understand the population of the clinical trial site’s catchment area and the estimated incidence of COVID-19 in the area. This is particularly crucial for Phase III trials that are evaluating the efficacy of vaccines and drugs. Due to curfews and travel restrictions, the transportation of patients from outside the catchment areas of the clinical trial site may be limited, which can significantly impact study enrolment.
3. Investigator and Site Experience
The protocol designs for COVID-19 clinical trials are becoming increasingly complex, with adaptive designs being quite common. Thus, it is critical to have experienced investigators who are capable of conducting complex clinical trials. Due to the rapidly evolving COVID-19 epidemiology in waves, and sponsors setting ambitious timeline goals, it is important for clinical trial sites to have experienced investigators, study coordinators, laboratory personnel, and pharmacy personnel. Additionally, it is important to have a research continuity plan in place. When conducting vaccine studies, it is important to consider whether the clinical trial site has experience transporting, storing, handling, and managing GMO vaccines. Furthermore, the assessment of the adequacy of pharmacy equipment and access control, among other considerations, is essential.
4. Regulatory Approval Process and Timelines
In response to the COVID-19 pandemic, ethics committees and regulatory authorities in most African countries have issued revised guidance for conducting COVID-19-related clinical trials. The latest regulatory guidelines prioritize COVID-19 clinical trials and have been revised to respond to pandemic situations. The positive news is that COVID-19 protocols have been granted expedited review, and in some countries, the review and approval of the protocol are done in parallel. Regulatory approvals have been significantly shortened in most African countries, taking only 2-6 weeks.
5. Clinical Site Capacity and Supply Chain
The COVID-19 pandemic can disrupt the supply chain for laboratory test articles, equipment, investigational products, and planned shipment of biological samples for PK and immunogenicity endpoint analysis in North America and Europe. Therefore, when selecting clinical trial sites, it is crucial to consider site infrastructures such as cold-chain storage capacity for large amounts of biological samples and longer periods of storage. Sponsors should also assess workspaces to ensure sufficient workspaces allow for infection prevention and the provision of PPE for staff and patients.
