The Spanish Agency of Medicines and Health Products (AEMPS), as the competent national authority in the authorization of clinical trials, has proposed a series of recommendations of exceptional application during the period of the COVID-19 crisis in Spain, which are intended to preserve the trial activities as far as possible, guaranteeing the healthcare of the patients, protecting their safety and well-being and preserving the traceability of the actions implemented in this health emergency situation.
“It is essential to maintain the maximum capacity of the health system reducing the risk of infection for the population,” stresses this regulatory body. In addition, he adds that “we must take into account the measures applied in the different autonomous communities after the declaration of the State of Alert by the Government.”
In this context, the AEMPS points out that “scheduled follow-up visits, access by external personnel to the centers and monitoring of the on-site trial could be compromised.” In some cases, he clarifies that “it might be necessary to transfer a patient from one center to another to facilitate their healthcare.” On the other hand, he remarks that “there may be a decrease in the staff of the promoter in charge of monitoring the trial.”
Likewise, this Agency highlights that “it is important that the promoter, together with the researcher, make a risk analysis and prioritize the activities that are critical and the way in which they should be carried out. Both should evaluate the application of these measures in a proportionate way for each clinical trial considering their particularities, the organization of each center and the epidemiological characteristics of COVID-19 in it ”. These measures may be updated to adapt to epidemiological developments as determined by the Ministry of Health.
Any such exceptional measures taken must be duly documented in the trial file. However, its application does not require prior approval on a case-by-case basis as a substantial modification by the AEMPS or by the Ethics Committee for Drug Research (CEIm), nor the individual notification of serious breaches of the protocol, except when expressly required in the point 2. In the four months following the date in which it is considered that the COVID-19 crisis ended in Spain, the promoter must communicate for each trial a report on the exceptional measures adopted that will be sent to the Agency and the CEIm.
At Distefar we support and share exceptional application measures for clinical trials during the period of the COVID-19 crisis in Spain.