In 2023, Likak Research, a Clinical Research Organization (CRO) based in Dakar, Senegal, was awarded a new vaccine trial in three sub-Saharan countries: Mali, Mozambique, and Kenya. It is a double-blinded, age-descending, randomized, and placebo-controlled trial to evaluate the safety and immunogenicity of the proposed salmonella trial vaccine. The trial aims to progress from adults to children, then to toddlers, and infants, recruiting cohorts of participants in progressively younger age groups, from 35 years down to 12-18 weeks of age. 

The first monitoring visit was in March 2023 and the final cohort enrollment is planned for August 2024, with infants aged 12-18 weeks. Our two biggest challenges in remotely monitoring this trial were 1) performing source document review and 2) investigational product accountability. Based on the Sponsor’s request, the monitoring scope also includes 100% verification of all informed consent forms (ICFs) and participant’s diaries to record solicited adverse events. These paper forms are source documents to later inform corresponding electronic Case Report Forms (eCRFs) in the Electronic Data Capture system (EDC). Reviewing all these paper documents, including performing source data verification, without being physically present at the site was a real challenge. 

Likak had to update its standard operating procedures to include a remote review component, outlining a step-by-step process that protects participants’ identifiable information with restricted access and limited retention. 

Likak also created shared folders using a secure file-hosting service. Each site has four sub-folders: one for the Investigator Study File (ISF), one for the ICFs, one for participant diaries, and one for pharmacy documents containing unblinded information. Each sub-folder is restricted to appropriate site staff (based on the delegation log) and monitors. The ICF subfolder, which includes identifiable information, has limited retention and access restricted to appropriate blinded staff and monitors only. The Sponsor does not have access to this sub-folder. All documents sent in agreed batches are posted in the share folders for a limited amount of time during which monitors must complete their review. After the pre-defined time, site would remove/destroy all documents from the share folders.  In the same manner, unblinded monitors manage the unblinded pharmacy sub-folder, accessible only to appropriate unblinded roles. 

Another system is in place to allow for a remote review of the ISF, using the Likak ISF checklist as a filing reference.

The second challenge Likak addressed was performing investigational product accountability remotely. Part of the solution involved using the file-sharing and review process described above for the unblinded documents. Additionally, Likak used WhatsApp video calls to perform IP accountability. Although challenging due to the poor quality of the internet in Africa, we overcame this obstacle through patience, training, and mentoring of the sites.

 It is a great opportunity for Likak to conduct this trial with 100% remote monitoring. This experience contributed to making Likak a more resilient organization. The main lesson learned is that solving challenges like those faced in remote monitoring requires the support and collaboration of all stakeholders. We could never have made this alone. With commitment and teamwork, the impossible becomes achievable, fostering a sense of shared responsibility and accountability among all involved.

A big thank you to the sponsor who trusted us with this trial and our new innovative processes.

A big thank you to all our site teams. They’ve been so patient and efficient!!

Authors:Fallowne Mbadinga KOLA, Dr Thierno Moustapha Diallo, Dr Cheick Mohamed Keita, Dr Elisabeth Liyong Diallo.