Maintaining high standards of clinical research during the Covid-19 pandemic: insights from an excellence clinical research centre

Abstract

Among the many ways the Covid-19 pandemic has harmed society, one is a severe reduction in the global clinical trial activity, ironically concomitant with a tremendous increase in research around the illness, treatments, and vaccines. It has been claimed that around 80% of the non-Covid-19 trials have been stopped or interrupted during the pandemic. This number is supported by data from Clinicaltrials.gov registry, which gave the pandemic as the reason for 86% of the 1052 trial suspensions between March and April 2020. Medical science is suffering, but so are today’s patients who are losing the potential therapeutic benefits offered by clinical trials. In cardiovascular medicine, many trials include vulnerable patients who are at increased risk from severe Covid-19 infection. As a result, plenty of trials have been halted or prematurely ended. It is understandable that patients do not want to participate in elective clinical trials; in fact, patient enrolment appeared to be the main reason for reduced clinical trial activity, due to either a reduction in screening for potential patients or logistical difficulties with treatment delivery. At the same time, scientific authorities and research centres have done their best to protect the already enrolled participants. The European Medicines Agency and United States Food and Drug Administration issued guidance on strategies to deal with the consequences of Covid-19 and to adapt patients’ care to the new context, calling for urgent amendments of protocols. The dismal situation is not unavoidable, however. There are a number of examples of successfully conducted cardiovascular research since the pandemic started. As researchers we have an opportunity to learn from how other institutes have coped with the pandemic. We here describe our experience from the National University of Ireland (NUIG) and Galway University Hospital before and during the Covid19 pandemic. Local situations differ, but some of our learnings may be of use to other cardiovascular hospitals and research centres. We conducted a retrospective analysis of our local databases, reporting data for patient screening visits, clinical trial enrolment rates, and follow-up visits of ongoing trials in the field of interventional cardiology at NUIG. Data are available under formal and reasoned request to the corresponding author. The analysis included a period of 2 years, from March 2019 to April 2021. Two groups were defined according to the presence of Covid-19 pandemic: pre-pandemic (March 2019– February 2020) and pandemic (March 2020–May 2021) periods. Overall, 23 different clinical trials were ongoing during the study period. Twelve were active during the pre-pandemic period; 3 of these completed as planned before March 2020, while 9 continued. With 11 trials initiating during the pandemic, 20 trials were ongoing between March 2020 and May 2021. Trials were grouped according to the investigated topic: coronary procedures, structural interventions, heart failure endovascular treatment, hypertension endovascular treatment, and other endovascular procedures. During the pre-pandemic period, three trials involved coronary procedures (25%), one trial concerned endovascular devices for heart failure (8.3%), one regarded endovascular treatment of hypertension (8.3%), no studies included structural interventions (0%), and seven were related to other endovascular interventions (58.3%). During the pandemic period seven trials involved coronary procedures (35%), four endovascular hypertension treatment (0%), two device implantation for heart failure patients (10%), one structural interventions (5%), and six other endovascular interventions (30%). The total number of screening visits, enrolments, and follow-up visits amounted to 1078 over the 2 years. Of these, 360 were carried out