The Agencia Española del Medicamento has approved 80 drug trials for Covid-19 within a month and has many other proposals pending.
THE Covid-19 health crisis has created a high demand for drug trial approvals. In the last month, the Agencia Española del Medicamento has received some 120 “intentions of interest,” says César Hernández, head of the department of Medicamentos de Uso Humano. Of these, 35 have been specified in the formal presentation of a document, of which 21 have already been approved and are in progress. In addition, permission has been given to carry out another 57 observational studies. The latter is easier because they consist of gathering information about what is happening, not starting new actions, explains Hernández.
For example, the Epicos essay, announced on Thursday by the Minister of Health, Salvador Illa, belongs to the first group. It consists of selecting groups of health personnel to give them one medicine or another to see if some antiviral or anti-inflammatory drugs reduce the risk of contagion. An example of an observational study could be to measure whether mortality is lower among patients who have been given an antibiotic.
This specialist calculates that of the rest of the 120 initiatives some will never come to fruition, but others will become trials. In certain cases, if they worked with the same idea, they have been asked to group together. “It is more interesting that they come together, that there are fewer but larger initiatives so that it does not happen as in China, where many trials were carried out with so few people that the results have not been useful,” says Hernández. For example, trials with hydroxychloroquine and antiretrovirals were conducted in China, but with so few volunteers that it was not possible to draw a conclusion. Now they are being done in other countries, including Spain.
A characteristic of this barrage of applications is that most of them have started from ‘non-commercial promoters,’ unlike what is more common, such as a laboratory promoting research because it is interested in putting a molecule on the market. Among them are the foundations and research institutes of the hospitals themselves; the National AIDS Plan, which will pilot the Epicos trial, and the World Health Organisation. They are the instigators of observational studies and, somewhat unusual, 14 of the 21 works in new medicines or in changes of the utility of some already approved. In total, non-commercial developers are 90 per cent of the total.
For Hernández, the high number of initiatives is good for everyone: it encourages research in Spain, allows groups to gain experience and take advantage of the great potential of Spanish public health, which, due to its universal access and technical level, is traditionally a good participant in large-scale trials. In this case, there are also many affected, which makes it much easier to get volunteers.