The clinical trial data yielded useful information quickly
Researchers have welcomed a new rapid clinical trial system designed to help pharmaceutical firms source key efficacy data for medicines focused on fighting an epidemic during rather than after an outbreak. They have been involved in a Wellcome Trust-funded trial of the experimental anti-Ebola drug TKM-130803, details of which were published in the journal PLOS Medicine.
While the medicine did not help patients with advanced Ebola, researchers say data yielded may help prove its effectiveness during earlier stages of the disease. Moreover, the system itself yielded useful information, quickly.
Professor Peter Horby, the study’s chief investigator, said: 'Thanks to the tremendous efforts of everyone involved we now have a much clearer picture of the potential of this drug. We are obviously disappointed that it does not seem to offer a benefit to patients with severe Ebola but it remains to be seen if the drug will help those with less severe illness.
'With results of on-going tests, researchers will glean a better understanding of 'the optimal dose for any further studies,' he said.
The PLOS paper details the trial design, which enables studies 'to be deployed quickly, adapt flexibly and provide results soon enough to influence the course of the current epidemic rather than just providing evidence for use should Ebola break out again'.
It added: 'Lessons are drawn for the conduct of clinical research in future outbreaks of infectious diseases, where the sequence of events may or may not be similar to the West African Ebola epidemic.'