Stakeholder collaboration
MAY, DISEASE, RECRUITMENT
Study protocol development involved various stakeholders, including the investigators, funding bodies, study sponsors, the South African Health Products Authority (SAHPRA), and the Gauteng Provincial Government as well as review by a scientific advisory committee comprising investigators and academics involved in other COVID-19-related projects. The process of agreeing on the protocol was complicated by uncertainties around the most relevant endpoints and the need to carefully examine emerging evidence regarding the potential risks and benefits for the investigational drugs in a new disease in a patient population that might not otherwise have healthcare access, and so be vulnerable to undue influence [The protocol was finalised in May 2020, with recruitment planned to begin in July 2020. However, further delays caused by repeated reviews of the protocol pushed this back to September, missing the first COVID-19 wave (Fig. The challenges posed by delay/uncertainty with regard to recruitment made it necessary to ensure very frequent alignment and sharing of information between the donors, the sponsor, the operational lead, the clinical research organisation, and the study site. These requirements to regularly develop and update risk mitigation and contingency plans represented an additional burden to a complex project. Certain activities required approval from multiple stakeholders prior to implementation, sometimes resulting in significant delays. Also, some study drugs had to be resupplied after reaching their expiry date.With multiple stakeholder involvement, clear and efficient boundaries need to be established to define responsibilities, reporting channels, and processes at study inception. This is especially important where new working relationships are being fostered. In addition, there must be upfront agreement to adhere to protocol review timelines with pre-determined decision points to avoid later delays, unless it is absolutely necessary to postpone decisions pending availability of further data. Given the uncertainty around conducting clinical trials in a new disease, a financial buffer to mitigate unanticipated expenses should also be accounted for at study start.