Clinical trials: guidelines and action during state of emergency

Given the health emergency caused by COVID-19, the Spanish Agency of Medicinal Products and Medical Devices (“AEMPS”) has stressed the importance of continuing with the ongoing clinical trials. It considers that certain government measures (e.g., restrictions on the free movement of persons) could jeopardize both follow-up visits to clinical trial participants and researchers’ access to trial sites. AEMPS has also emphasized the need to prioritize the assessment and starting of new trials intended to prevent and treat COVID-19.

Below we provide an overview of the guidelines for sponsors and researchers:

• Onsite visits of participants. Sponsors and researchers can postpone and reschedule follow-up visits, or follow up through other channels, including telephone calls with the participants. Apparently, this would not affect clinical trials subject to remote monitoring.  According to AEMPS, postponing or rescheduling visits would not be considered a serious breach of the clinical trial protocol unless this leads to health risks for participants. 
• “Recruitment” of new participants. Sponsors and researchers will assess the risks and the benefits, considering the trial’s main characteristics, as well as the trial site’s condition and circumstances. This analysis could lead to a stopping of the “recruitment” of new trial participants or to discontinuing treatment, to prevent unnecessary risks to participants. In these cases, the sponsor must submit a report stating its decision on these interruptions to AEMPS and the relevant ethics committee.
• Access to the tested drug or medicinal product. It should be ensured that participants access the tested medicinal product under the same conditions as they did before the COVID-19 outbreak. Therefore, AEMPS recommends researchers to evaluate the possibility of providing participants with enough medicinal product to cover a longer treatment period.
• Follow-up visits. AEMPS recommends sponsors update monitoring plans for a four-month prospective period, prioritizing centralized and remote monitoring of the trial sites involved. It also stresses that verification of clinical trial data by researchers be postponed until medical records can be reviewed in person. Accordingly, sponsors could agree with the relevant sites and the research staff on the new measures applicable to trial monitoring.
• Transfers of participants to other sites. These transfers are only allowed if necessary. From a data protection perspective, this is the most significant point. It is essential to consider any obstacles or red tape applicable to transfers under the relevant informed consent forms, the clinical trial protocol or any other document entered into to carry out the trial.

According to AEMPS, any transfer or relocation of participants must meet the following requirements: (i) the trial sites involved must enter into a transfer agreement, (ii) the receiving site must have access to the participant’s medical records, (iii) the transferring site must submit an overview of the participant’s most important clinical data to assist the receiving site, and (iv) the transfer must be recorded and documented by both sites.

Finally, AEMPS has also emphasized the need to prioritize the assessment and starting of new trials intended to prevent and treat COVID-19. Accordingly, on April 2, 2020, the Ministry of Health confirmed that AEMPS had authorized 13 clinical trials in this area and that it was currently evaluating 98 medicinal product applications (for new products or for new medical uses of known products) to manage COVID-19.

Authors: Alejandro Negro and Raúl Pérez