Holiday Closure (Friday, 18 th December 2020 – Monday 4 th January 2021)December 16, 2020
Millions of people in the United States have received COVID-19 vaccines since Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines were authorized for emergency use by US FDA. Finding reputable and high-quality sites for new Covid-19 vaccine and drug clinical trials can be a huge challenge. Infact, as the COVID-19 vaccine becomes more available in the West, new trials have challenges reaching enrolment targets. As a result, more clinical trials are shifting to the global south. Sponsors determined to beat the ambitious development timeline goals are shifting to internal sites, including Africa.
Traditional pre-COVID-19 approaches to clinical site assessment are not keeping pace with the increase in Covid-19 trial complexities observed across the industry. Furthermore, the COVID-19 pandemic has introduced unique challenges at the clinical sites and has highlighted new barriers to performance at previously high-performing international sites. As a result, site selection for Covid-19 clinical trials has inherently become a more difficult task.
This article highlights five (5) key considerations sponsors and CROs should assess during site selection for COVID-19 clinical trials in Africa.
Political interference in public health science has increased significantly during the COVID-19 pandemic. Before choosing a country for the COVID-19 vaccine or drug, sponsors should establish whether there is political support for COVID-19 research at government levels. In addition, sponsors and CROs must understand the sensitivities around COVID-19 vaccines and/or clinical trials.
Local Epidemiology of COVID-19
African countries have imposed travel restrictions developing on situational reports. Sponsors and CROs should have visibility regarding the population of the site's catchment area and estimated incidence of COVID-19, especially for Phase III trials evaluating the efficacy of vaccines and drugs. Transporting patients from outside catchment areas of the sites is limited due to the curfews and this can impact study enrolment.
COVID-19 protocol designs are increasingly becoming complex. Adaptive designs are not uncommon. Investigator experience in conducting complex clinical trials is crucial. Because COVID-19 epidemiology evolves quickly in waves and sponsors have set ambitious timeline goals, sites should have experienced investigators, study coordinators, laboratory and pharmacy personnel. In addition, a research continuity plan is essential. For vaccine studies, consider whether sites have experience with transport, storage, handling, and management of GMO vaccines. Assessment of adequacy of pharmacy equipment, access control among other considerations is essential.
Ethic committees and regulatory authorities in the majority of African countries have issued revised guidance regarding the conduct of COVID-19 related clinical trials. The latest regulatory guidelines have been revised to respond to COVID-19 pandemic situations in order to prioritize COVID-19 clinical trials. The good news is that COVID-19 protocols have been afforded expedited review and in some countries, the review and approvals of the protocol are done in parallel. Regulatory approvals have been shortened to 2 - 6 weeks in most African countries.
Site Infrastructure and Supplies Management
COVID-19 pandemic can disrupt the supply chain for laboratory test articles, equipment, an investigational product, and planned shipment of biological samples for PK and immunogenicity endpoint analysis in North America and Europe. Site selection should take into account site infrastructures such as cold-chain storage capacity for large amounts of biological samples and longer periods of storage. In addition, sponsors should assess workspaces to ensure there are ample workspaces that allow infection prevention, and PPE for staff and patients.
Now that you know the 5 most important factors to consider while selecting sites for Covid-19 clinical trials for Africa, which of these are you going to add to your site assessment survey? Please leave me a comment below.