Due to the COVID-19 situation, the Spanish Agency for Medicines and Healthcare Products (AEMPS) designed exceptional measures applicable to clinical trials in Spain to manage problems arising from the COVID-19 emergency. These measures are designed to ensure trial activity, patient’s safety and welfare, and traceability of implemented actions.
Any such exceptional measures taken must be duly documented in the study file and reported within four months of the date on which the COVID-19 crisis is considered to have ended in Spain. Importantly, the implementation of these exceptional measures does not require either prior approval, on a case-by-case basis, as a substantial amendment by the AEMPS or the Ethics Committee (CEIm), or an individual notification of serious breach to the protocol (except where expressly required, see point 2).
- Scheduled on site visits of clinical trial patients: the convenience of postponing visits, or to turn them into telephonic visits should be considered, except for scheduled site visits that are critical.
- Enrolment of new patients: based on a benefit/risk assessment the recruitment and even treatment of trial patients may be discontinued in the interest of avoiding unnecessary risks. This analysis is particularly relevant in clinical trials involving treatment with immunosuppressants, with no expectation of benefit to participants. In the case of a trial interruption, the sponsor would have to notify such measures as “urgent safety measures” explaining the steps taken to ensure alternative treatment of the patients by sending an Ad Hoc report to both the AEMPS and CEIm within 15 days of the interruption or termination.
- Access to trial medication: ppatients should be guaranteed access to trial medication under the same conditions as it was being given.
- Monitoring visits: the sponsor is advised to update the trial monitoring plans for the next four months by prioritizing centralized monitoring and remote monitoring of participating sites and postponing as far as possible the verification of source data until the medical history can be accessed in person.
- Transfer of patients from one site to another: this can be done provided that a) a transfer agreement is signed between the sites, b) the new site has access to the case record form (CRF) and the patient’s medical record, c) the original site sends a transfer report summarizing the most relevant medical data of the patient in relation to the trial in order to facilitate the follow-up of the trial to the new site, d) the transfer of the patient is documented in the trial file of both sites.
- Clinical trials addressed to research with new drugs against coronavirus: The AEMPS is prioritizing, together with the ECs, the evaluation of clinical trials aimed at treating or preventing coronavirus disease. Sponsors or investigators who have a clinical trial of this type should send a message to the Clinical Trials Area indicating in the subject line: URGENT new EC COVID19. A response will be given the same day.