Clinical trial laboratory principles for emerging infectious disease research in resource-limited settings

For emerging and re-emerging viral diseases, the timing and location of outbreaks are typically unpredictable and may require rapid implementation of randomized controlled trials (RCTs) to evaluate safety and efficacy of candidate vaccines or therapeutics. In austere and hard-to-reach settings, establishing effective laboratory operations for RCTs requires considerable effort to address both anticipated and unforeseen challenges. Here, we describe key principles and practical challenges associated with effective research laboratory operationalization in the context of a double-blinded, placebo-controlled RCT for evaluation of an mpox candidate therapeutic in the Democratic Republic of the Congo. The solutions implemented and lessons learned may inform the planning and operationalization of clinical trial laboratories in resource-limited outbreak settings and provide a framework to guide future efforts.