October 29, 2020

are troubled times for clinical trials


Right now there are around 200 vaccine research projects against COVID-19 in the world. In 25 of them, vaccines are already being evaluated in clinical trials. Chinese biopharmaceutical company Sinovac, CanSino Biological (together with the Beijing Institute of Biotechnology) and pharmaceutical AstraZeneca (together with Oxford University) are leading the race for the precious vaccine. Both are in the last phase before their possible authorization and commercialization if their efficacy is demonstrated: clinical phase III, where their preventive effect against the coronavirus on thousands of volunteers is evaluated.

Can a country like Spain, weighed down by years of research cuts, produce a vaccine against COVID-19?

Can a country like Spain, weighed down by years of research cuts, produce a vaccine against COVID-19?

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Research on coronavirus treatments and vaccines has been and continues to be intense: there are more than 2,500 registered clinical trials. However, the COVID-19 pandemic has markedly affected preclinical and clinical research for a multitude of treatments outside of this infectious disease. According to the consulting firm GlobalData, around 1,300 trials have been suspended worldwide until June. Scientists in Spain have also had to face this situation, in addition to the added difficulties in researching vaccines against the coronavirus due to the lack of experimental macaques and the shortage of factories capable of producing vaccines on a large scale.

Óscar Mesa, executive director of QualitecFarma, a company dedicated to conducting clinical trials in Spain, explains to elDiario.es how it has affected clinical research in our country: “Research unrelated to COVID-19 has slowed down in recent years months, since ongoing clinical trials have failed to advance patient recruitment or monitoring as centers have closed […]. The fact of having closed borders, travel in general and, of course, the closure of hospital centers and their focus on helping COVID-19 patients, almost collapsing many health systems, has made patients involved in other research projects have monitoring of said tests slowed down. This, together with the logical apprehension of patients, researchers, monitors and research companies, has greatly slowed down the activity. Currently it seems that the centers are once again opening to the visit of both patients and monitors and little by little the normal development of the processes is allowed again. ”

Many of the clinical trials affected by the pandemic have had no significant negative effects for patients, as oral treatments, for example, have been made available, even if by mail. However, trials with more complicated treatments, such as those given intravenously, have suffered much more problems. The American Society for Clinical Oncology conducted a survey in May to find out how COVID-19 had affected cancer clinical trials. About 60% of researchers reported that the pandemic had had high or moderate impact on patient visits, which were canceled or delayed. Several of the experimental therapies are the only or the best treatment option for patients affected by various diseases, and the pandemic has made access to them difficult.

Controversial proposals to speed up the vaccine

Clinical trials, essential to find out the efficacy of a vaccine against the SARS-CoV-2 virus, are the main reason why the accelerator cannot be stepped on, even though the pandemic urgently demands a vaccine. When vaccines are administered to volunteers, it is necessary to monitor for months to detect whether these people suffer significant adverse effects and to check if they are more protected against infectious disease than the control group and their risk of contagion is therefore lower.

If there is no community transmission in the area where the volunteers live, this phase can be lengthened, since it is more difficult to recognize the efficacy of a vaccine when infections are restricted by the different established public health measures. To speed up research on COVID-19 vaccines, thousands of people in the United States are publicly volunteering to play guinea pigs. They not only seek to receive the vaccine, but also to purposely expose themselves to the coronavirus so that the usefulness of this preventive treatment becomes clear as soon as possible.

The initiative 1 day sooner (One day before), which includes these volunteers, already accumulates more than 30,000 people from 140 different countries. However, clinical trial legislation does not, in principle, allow this controversial alternative. In large part, due to the risks involved: even if they are young people, they are not exempt from suffering a severe COVID-19 and dying. It is estimated that around 0.2% of people ages 20-44 die from infection by the SARS-CoV-2 virus.

Óscar Mesa is clear about this initiative: “Vaccine research does not assume the inclusion of patients with the disease nor does it allow the inoculation of the disease in healthy volunteers […]. Every healthy patient or volunteer included in a clinical trial must sign one of the most important regulatory documents in clinical research, which is informed consent. Biomedical research at the international level must comply with a series of legal and above all ethical requirements for the proper development of the process and the strict vigilance of the regulation. From an ethical point of view it is absolutely impossible and I suppose that no government or international health authority would approve of this assumption. However, it is the governments that in such a situation would make the decision to violate an ethical code that puts on the table the benefit / risk ratio, which as we well know is one of the maxims observed during the development of drugs in general. ”

Precisely, the Chinese government has been the first to make a controversial decision about its star coronavirus vaccine: CanSino. Although it is still an experimental vaccine, in phase III clinical trials, and its efficacy is still unknown, its use was approved for one year for military personnel in late June. It has not yet been clarified whether this vaccination will be mandatory or optional, and there are no guarantees that the vaccine will be marketed. Despite this, the Chinese military will be the first people in the world, outside of a clinical trial, to receive a potential coronavirus vaccine. A decision that many scientists have described as risky and that is only the latest episode in the turbulent times of biomedical research immersed in a pandemic.

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