Dispatches from PCT Europe

Future epidemic trials must cut through red tape, says Ebola researcher

By Dan Stanton

- Last updated on GMT

Ebola researcher: Future epidemic trials must cut through red tape

Related tags Clinical trials Epidemiology

A professor who conducted fast-track trials during last year’s Ebola outbreak says next time such trials must be part of humanitarian response… because there will be a next time.

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.”

Future planning

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.

Related news

Show more

Related products

show more

The Right CDMO Can Unlock Faster Drug Development

The Right CDMO Can Unlock Faster Drug Development

Content provided by Lonza Small Molecules | 15-May-2023 | Interview

Drug development presents biotech companies with ever-changing challenges. Enabling a faster end-to-end process requires seamless flexibility and extensive...

SDTM supplemental qualifiers explained

SDTM supplemental qualifiers explained

Content provided by Formedix | 12-May-2023 | White Paper

What are SDTM supplemental qualifiers? In short, these are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard....

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Content provided by Formedix | 17-Apr-2023 | White Paper

Companies often have to conduct multiple clinical trials at the same time, which means they've got to be efficient, and compliant with industry regulations....

Related suppliers

Follow us

Products

View more

Webinars