In an article published in Cinco Días on how the COVID-19 pandemic has altered the way clinical trials are conducted, the Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU) states that in the field of rare diseases, neurology, internal medicine and cardiology units have also been affected.
According to the association, "the slowdown in patient recruitment due to restrictions on access to hospitals has directly impacted on the collection and publication of results. Results are now expected six months to a year later. These limitations have also conditioned training and dedication on the part of healthcare professionals, as well as making face-to-face visits by trial sponsors more difficult, impacting on the status of trial databases.
However, AELMHU points out that Spain is in a similar situation to its European partners. "Although it has been one of the EU Member States hardest hit by the coronavirus, the process to recover the usual pace of clinical research is being done at the same level as in other States, allowing an almost total recovery of activity, depending on the characteristics and situation of each centre.
The article highlights that there are new rules, protocols and digital tools to maintain research activity in these extraordinary times. It underlines that the epidemic, in general, has made patient recruitment and follow-up, access to centres, medication collection and face-to-face monitoring more difficult. It has also led to saturation of ethics committees and some delays in contract evaluations and signatures.
According to Amelia Martín Uranga, head of Farmaindustria's innovative medicines platform, "during the hardest months of the pandemic, the monitors had to leave the hospitals and new recruitments could not be made. But on 11 May [with the de-escalation] they returned, and even the researchers themselves have resumed activity. Despite the way the virus is hitting us, research has been maintained in the centres because it is part of care.
The Ministry of Health details that the total number of clinical trials with medicines has been maintained. As of 22 October, the number of authorisations (708) was similar to that of 2019 (690). In addition, there has been a significant increase in applications (167) and authorisations (131) for COVID-19 (not only for drug replacements, but also for new molecules), meaning that the area of viral infections now accounts for 18%.
