Doctors, institutions and research and financing organizations from 30 countries announced this Thursday (2) the creation of a network to accelerate studies on the new coronavirus.
The initiative, called the Covid-19 Clinical Research Coalition, has a special focus on poorer countries. The goal is to find alternatives at reasonable prices and, once they are defined, ensure that the greatest number of people are served.
“It is not possible to stop treating part of the population,” says Jadel Kratz, Research and Development manager at the Medicines for Neglected Diseases Initiative (DNDi), one of the project members.
In a statement published in the British medical journal Lancet, the coalition notes that, of the almost 600 clinical trials to combat Covid-19, few are planned for lower-income countries. The failure, in the group's assessment, needs to be quickly corrected. “Covid-19 is a global disease. It is important that everyone evaluates interventions in their own population, especially considering the peculiarities of each country”, says Kratz.
To speed up research, reduce waste and ensure faster results, the coalition is committed to using platforms so that data can be used and shared in a standardized way.
“This increases transparency, allows information to be compared and reduces research repetitions”, says professor Luiz Carlos Dias, professor at the Chemistry Institute of the State University of Campinas (Unicamp), who is part of the coalition.
The Oswaldo Cruz Foundation is also on the list of Brazilian participants in the network launched this Thursday. The president of the foundation, Nisia Trindade Lima, reinforces the need to look at developing countries and the importance of research results being shared with institutions and managers. “We are facing a global disaster. This requires a lot of research, a quick and efficient response”, he adds.
Fiocruz announced last week its participation in the Solidariedade project, coordinated by the WHO (World Health Organization), to evaluate the effectiveness of medicines already available on the market for the treatment of Covid-19. The data will also be used to fuel the coalition's platform.
Kratz highlights that many studies related to the new coronavirus are already underway, and some of them have very similar objectives and designs. At first, this could be considered a waste. With data standardization, it is possible to have more robust answers to certain questions. “The number of research participants will be greater, which may provide more reliable information.”
In the case of studies that have not yet started, the coalition will be able to help format the research, which will also help with comparison. “The initiative can help put those leading the work in the same forum, share ideas, make adjustments to the design”, says the DNDi member.
He also emphasizes that the purpose is not to lead the agenda or coordinate additional studies. “The idea is to organize institutions, support initiatives already underway.”
It is not just in the study design that the platform can help. The standardization of data on the platform could also be useful in the case of the need to register medicines in countries or in facilitating the adoption of access policies to therapies. The research network must also offer a series of mechanisms to support and bring research centers together to obtain funding.
In the document published in the Lancet magazine, members of the coalition highlight the importance of observing ethical principles. Dias notes that, given the population's demand, some countries are rushing to present therapeutic alternatives without proof. For him, this can bring numerous risks. “Decision making must be based on solid results.”
He assesses that results presented so far for hydroxychloroquine, a medication used to treat arthritis and lupus, for example, are initial and should only be presented as a treatment perspective, not a guarantee.
The president of Fiocruz believes it is important to speed up analysis processes at this time. “Saving lives is the greatest ethical value. This does not mean validating the effectiveness of drugs without studies, but accelerating the work.”
Kratz notes that the National Research Ethics Commission approved 16 clinical studies related to the new coronavirus, demonstrating the agility of the analysis. The DNDi manager, however, notes that there is still some learning to be done along the way. He recognizes there is pressure to find results quickly. “Everyone is rooting for this. But we can't skip steps. Nor do bad science now. Even skipping steps or accelerating processes, it is important that everything is linked to ethics and good processes.”
Asked whether offering hydroxychloroquine in services for use, at the discretion of doctors, in the most serious cases of Covid-19, was good medical practice, Kratz summarized: “All risk management.” He then added: “If it were a completely experimental drug, about which we had no information, it would be unfeasible.” He recalled, however, that studies collected so far have limitations. “I hope that experimental use data can help in evaluating the drug’s effectiveness.”
