This modern week shared more data on efficacy of your vaccine. In a concise line of the press release it was revealed that one of the participants who had received a placebo died of covid-19. Now that the first vaccines they begin to be approvedIs it ethical to continue clinical trials in which some volunteers do not receive the treatment? A perspective article published today in the magazine Science analyze the question.
"When there is a vaccine or treatment it is more complicated for an agency to accept [hacer un ensayo clínico] because it has ethical problems to give a placebo. If you can cure or protect a person, how can you not do it? ", The scientist from the National Center for Biotechnology (CNB-CSIC) explains to SINC Sonia Zuniga. "The more candidates arrive the more complicated [llevar a cabo este tipo de estudios]".
This, at least, is the theory. The debate is not new and there is much literature on it, but the global health crisis caused by the coronavirus is unprecedented. "This tension between protecting participants and collecting data that can benefit others is common in clinical research, […] but the current situation is incomparable, "write the authors of the Science.
Billions of people - including trial participants receiving placebo or candidates without proven efficacy - could benefit from a vaccine against a disease that until now has very limited treatments. However, the article assures that challenges such as those associated with the production of these products "underscore the potential value" of carrying out other trials even if options already exist. Ultimately, it will take multiple vaccines to meet global demand.
"We should continue clinical trials that still have social value and pose acceptable risks," the researcher from the US National Institutes of Health and co-author of the article explains to SINC. David wendler. Furthermore, it considers it essential to "obtain informed consent" from the participants so that they understand what they are exposed to.
Value versus risk
Wendler defines "social value" as the potential for some trials to provide valuable data, from greater confidence in vaccine estimates to more information on side effects. Too clear pending doubts as the duration of protection, the impact of the drug on old people or with comorbidities and assess whether the candidate avoid infection.
On the other side of the scale are the risks to which participants are exposed who may have received a vaccine that is already considered effective and safe. Wendler clarifies that this depends on the time during which the placebo is given, the health status of the volunteer and if he could have accessed a vaccine outside the clinical trial.
How do you know which way the balance tips? Which trials can continue and which cannot? Unfortunately, there is no algorithm that can evaluate it. That is why Wendler considers it "critical" that there is an "independent review" carried out by a Ethics Committee qualified and independent to "evaluate and confirm that conditions are met".
"Others [ensayos clínicos] they should stop, not start or be redesigned, "he says. As soon as" no "studio" satisfies the conditions "of owning a high social value and acceptable risks these "should stop".
Zúñiga, who is investigating one of the Spanish candidates, defends that clinical trials continue. "In the current pandemic situation with patients of all kinds around the world, I think we are not yet at that point and it will be at least a year before we reach it."
Wendler's article was written before Moderna announced that one of the participants had died as a result of COVID-19. "I am concerned that the evaluation of these clinical trials happens largely through press releases," he laments. "I don't think it's the best way to do it."
Baylor School of Medicine researcher and vaccine specialist Peter Hotez wrote a similar review on Twitter after the announcement. "I'm not sure we want to hear about a participant's death through a company press release. Considering what this means when it comes to continuing placebo-controlled clinical trials, shouldn't this discussion be directed by public health agencies? " Fighting a pandemic is no excuse for neglecting bioethics.