The term “randomized controlled trial” conjures up images of sterile, high-tech labs with closely monitored patients hooked up to numerous machines. That’s a far cry from the reality of a brave and groundbreaking trial that began last week in the Democratic Republic of the Congo to investigate lifesaving treatments for Ebola.
The DRC is in the midst of one of the worst Ebola outbreaks it has faced. With at least 260 people killed so far, it is the second-worst Ebola epidemic the world has faced.
This Ebola outbreak is spreading in an incredibly challenging region. It is affecting dense, urban areas, close to national borders, making transmission more likely. And many cases have emerged in extremely hostile and dangerous areas that are under attack from rebel groups and served by bad or nonexistent roads and limited electricity.
This situation puts health care workers and communities at risk from both disease and violence. Providing care, gathering data, tracing contacts, and making the vaccine — the legacy of the West African epidemic — available in this region is almost impossible.
Given these formidable conditions, why attempt a clinical trial?
Several experimental treatments have been given to 174 people infected with Ebola in the DRC under compassionate use. But we don’t know which one is the safest and most effective. Determining that can only happen during an outbreak or epidemic, when people have Ebola. Most clinical trials exclude pregnant women and children. That’s not the case here. Women and children will be included in the trial because of Ebola’s high mortality rate. It’s essential that they take part, given recent news that more babies and young children are being diagnosed than in previous outbreaks.
To get enough data, the clinical trials may have to span multiple outbreaks. But once we know if an Ebola treatment can save lives, we can make sure the vaccine or drug is licensed, available, and affordable to those who need it, where ever they are.
Making the decision to go ahead with the trial has not been easy. It is a highly complex undertaking. We should all pay tribute to the brave health care workers who are providing the best possible care and conducting this trial.
During difficult times, it can be all too easy to turn our backs and hide behind complexity as an excuse not to act. This important step forward has been made possible only through close collaboration between researchers, governments, nongovernmental organizations, companies, and funders.
There is no question that the current Ebola outbreak in the DRC would be far, far worse if there were no vaccine available. That vaccine exists only because of a trial in the devastating multiyear epidemic in West Africa — a trial that many at the time said was just too difficult to do.
To date, more than 42,000 people have received the vaccine in the DRC and not a single vaccinated person has been diagnosed with Ebola. But as effective as the vaccine may be, it alone will not be enough to keep this deadly disease at bay.
The world has learned a lot since the West Africa epidemic that took more than 11,000 lives. Yet we still dangerously underestimate our vulnerability. Epidemics strike suddenly. Governmental instability, climate change, conflict, and migration make it easier than ever for diseases to spread across countries. Just look at the effect the cholera epidemic is having in Yemen.
It’s time to stop reacting to these outbreaks as discrete episodes and instead work together with a coordinated, nationally led, and internationally supported approach that learns from each outbreak so we can better prepare for the next.
Multi-outbreak, multi-country trials are essential if we’re to find the best treatments for patients and the best vaccines. This trial, led by the DRC with the support of the National Institutes of Health; Medecins Sans Frontieres; ALIMA; the African Coalition for Epidemic Research, Response, and Training; the World Health Organization; industry; and others shows it can be done.
We won’t ever get rid of Ebola, but we can stop outbreaks of it from turning into major regional and national epidemics. This trial of treatments, and the vaccines we now have available, offer hope that we can turn this terrifying disease into a preventable and treatable one, ensuring the loss of as few lives as possible.
Jeremy Farrar, M.D., is the director of the Wellcome Trust, a global charitable foundation.