key: cord-1048830-gf5uzsi1 authors: Lunardi, Mattia; Mylotte, Darren; Wijns, William; Onuma, Yoshinobu; Soliman, Osama; Serruys, Patrick W; Sharif, Faisal title: Maintaining high standards of clinical research during the Covid-19 pandemic: insights from an excellence clinical research centre date: 2021-06-28 journal: Eur Heart J DOI: 10.1093/eurheartj/ehab409 sha: b5d50a13cf07a44d59d8722d4783f3414ac7c905 doc_id: 1048830 cord_uid: gf5uzsi1 nan 19 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 before the pandemic, while 718 during the pandemic period, with a significant increase of 33.2% (P ¼ 0.019). Compared to the pre-pandemic year, during the pandemic year, we significantly increased the proportion of visits and enrolments for coronary trials (52 vs. 198; 14.5% vs. 27.6%, P ¼ 0.032) and structural trials (0 vs. 103; 0% vs. 14.3%, P < 0.001). Heart failure studies visits and enrolment rates resulted comparable between the two periods (24 vs. 82; 6.6% vs. 11.4%, P ¼ 0.370). In contrast, the proportion of visits and enrolments for trials about hypertension and other endovascular treatments decreased during the pandemic: 200 vs. 273 (55.5% vs. 38.1%, P ¼ 0.010) and 84 vs. 62 (23.3% vs. 8.6%, P ¼ 0.013), respectively. Trends in absolute and relative numbers are depicted in Figure 1 . As these numbers show, NUIG not only maintained but even increased our clinical trial activity during the Covid-19 pandemic. There are probably multiple reasons for this ( Figure 2 ). Dedicated involvement of senior investigators is crucial to the success of clinical research programmes in general and in the challenging environment of a pandemic in particular. A group of expert interventional cardiologists with significant experience in clinical research, supported by the Higher Education Authorities and Science Foundation Ireland are involved in the development, initiation, and conduct of all trials at NUIG. Weekly meetings are held to sort out any issue related to research studies, to avoid delays and ensure consistent decisions and directives. Second, a dedicated research team seems to have helped. The presence of a working group composed of senior research nurses and clinical fellows dedicated to research supports the maintenance of organizational standards and a clear distribution of tasks. Every team member has a defined role, interacting with other members' roles, but tailored to individual skillsets and preferences. Third, focusing on life-saving clinical studies brings benefits to participating patients and study withdrawal might be life threatening. All studies in our analysis addressed real needs and most represented life-saving treatments for patients with cardiovascular conditions. Indeed, our data showed an increased proportion of trials related to coronary and structural interventions during the pandemic. This favoured the continuation of screening, enrolment and follow-up visits despite pandemic-related obstacles. Fourth, recruitment from private health facilities. The private hospitals in the area were Covid-19 free. This allowed high risk patients to be screened for Covid-19 and if negative, to be offered elective clinical trial procedures in the facilities. Additional ethics and clinical trials contracts were signed with the private hospitals to allow continuation of clinical trial service. Fifth: virtual proctoring. Initiation visits and practical proctoring for operators are fundamental at study initiation, in particular in the interventional medicine field. During the Covid-19 pandemic NUIG has introduced remote training for all staff, with simultaneous proctoring during interventions in order to continue ongoing studies and permit new trials to start. We implemented secure and high speed internet in the cath-labs, and placed two additional computers in the control room and in the labs, for the proctors to observe and advice operators during procedures. Sixth: telemedicine. This is the most common strategy implemented worldwide to keep high standards of care for the patients. When possible, all on-site visits were converted to virtual meetings, allowing timely follow-up consultations. Seventh: safety measures. To ensure the availability of in-person encounters, preventive measures were applied, with dedicated spaces assigned to research purposes, avoiding close contacts. Every person who enters the research centre is screened for Covid-19 symptoms, fever and potential exposure. Masks and physical distancing were required for all in-person interactions and no visitors allowed, except for one carer in the case of patients with disabilities. A combination of pre-existing and adaptive factors allowed clinical research at NUIG to respond to the multiple challenges posed by the Covid-19 pandemic. There was an inclusive clinical research platform for clinical investigations in interventional medicine; a solid pre-existing organization, highly motivated workforce, public/private collaboration, and not least, the fact that cardiovascular studies often involve lifesaving therapies. Continued success is not guaranteed, however. The pandemic is not past and Covid-19 may affect key study outcomes. Multiple reports CardioPulse around the world confirmed a large Covid-19-related reduction in ACS admissions, with an adverse effect on patients' outcomes due to delayed treatment or missed presentation. Covid-19 infection could raise or lower blood pressure in patients with hypertension leading to over-or underestimations of adverse events captured in clinical endpoints. Participants are also likely to have changed their lifestyle, adding a confounder. Researchers should be aware of these considerations in the future analysis and interpretation of trials results. 5 Bearing in mind all these limitations, future clinical research should also take advantage of the new strategies implemented during this particular period, in order to improve and accelerate the scientific progress. COVID-19 and readjusting clinical trials The impact of COVID-19 on clinical trials Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Impact of the COVID-19 pandemic on clinical research Conflict of interest: All authors have no conflicts of interest to declare.