During the Ebola epidemic in West Africa last year, a £3.2m ($4.9m) Wellcome Trust grant was used to conduct fast-tracked studies of investigational treatments in what were the first ever clinical trials done during a disease outbreak.
Trudie Lang, Professor of Global Research at Oxford University, was part of the team which designed and carried out the trials, and told delegates at PCT Hamburg Wednesday that among the many problems encountered – leadership challenges, African regulators being overwhelmed, ethical issues, and operational constraints - “the clinical response itself came too late.”
The outbreak itself officially began in February 2014 and lasted a year, but funding only began in September 2014 and was held up further through contract negotiations and bureaucracy.
For example, some contracts sat with lawyers for six weeks while IT terms were being approved and while this is fairly normal in regular clinical trials, such actions meant the first patient was not studied until January 2, just weeks before the outbreak was declared over.
“This was an impossible challenge as the epidemic was ending,” Lang said. “We need to plan properly next time for infectious disease outbreaks, because there will be a next time.”
Charitable efforts began almost immediately, she continued, and as such “clinical trials need to be part of the medical humanitarian response, not an add-on.”
Having a plan ahead of a future outbreak would also help make such trials more efficient, especially given the unknown timescales, but she said it is very difficult to get funding when there is no present risk of epidemic.
However, such mind-set is slowly changing and there are some pre-planning efforts occurring.
The WHO is currently writing an R&D blueprint for potential future outbreaks, giving guidelines on areas such as capturing data and manufacturing, and Lang herself is working on a project to tackle respiratory epidemics ahead of any emergencies.