Issue 8 2021

12 Acquisition International - Issue 8 2021 available, combined with regulatory requirements and company standard operating procedures that make clinical trials expensive to execute, it’s little wonder that many struggle to explore some of the more interesting areas of the industry. Even many interesting study ideas from individual Investigators will not be funded due to budget limitations. ECRI acts as an intermediary between thought leaders and supporting industry, building collaboration not just into the way a study is run, but into the very fabric of its being from the outset. When the team at ECRI work with their clients, they see them as partners to work closely with to ensure success. Every cardiovascular randomized clinical trial that the team conducts is an enormous endeavour that typically lasts for 5 to 7 years. This means that commitment and passion are critical from all parties. The core of an ECRI project is made of four basic components, starting with the ECRI managing director. This person acts as the sponsor representative for the trial. There are also the Principal Investigators and Steering Committee, who offer the scientific and medical leadership to the trial, the Grant-Givers who support the execution of the investigator initiates through restricted research grants, and finally Cardialysis, to which ECRI outsources all clinical trial and core laboratory execution activities. Often, more than one contract research organization is involved in ECRI trials sharing responsibilities with Cardialysis, either due to band width or geographic distribution. These parties are qualified and compliant ECRI and Cardialysis vendors. ECRI functions as independent sponsor for clinical trials, drastically reducing the workload to lead investigators, who would otherwise take the sponsor responsibilities at their academic institutions. ECRI utilizes Cardialysis, its sister organization, fromwhich it sources critical capabilities for sponsoring clinical trials. Its operational activities draw on almost 40 years of clinical trial expertise at Cardialysis. The culture of ECRI is the culture of Cardialysis. Both are proudly knowledge- based professional organizations, with regulatory-compliant processes, and top commitment for quality in clinical research. Over the years, ECRI has become characterized by accuracy in planning, budget oversight, compliance, and execution. ECRI operates on the basis of close collaboration and rapid communication among stakeholders. As a non-profit organization, ECRI is solely funded by research grants provided by the medical industry which typically is not involved in the design of the studies, but without which investigator-initiated studies could not be executed via ECRI. Moreover, they may facilitate devices or drugs, if this would be part of the agreed research grant contribution. ECRI operates within networks of clinical sites with extensive experience in clinical research who facilitate a timely patient enrolment. Being compliant to regulations at an institutional level as well as having the necessary logistics and personnel to set-up a clinical investigation, adequately consent patients, implement best practices for experimental therapies or devices, ensure timely and accurate data entry, as well as thorough follow-up of study participants, demand significant resources from participating sites and vouch for the unfaltering commitment of health care providers to improving patient care. ECRI networks goes beyond Europe and are represented globally. The challenges of the COVID-19 pandemic have affected every industry around the world, and as many other leaders in the field, ECRI adapted through the pandemic. Given the primary focus on device and open-label pharma trials, ECRI’s completed on time studies planned to end in 2020 and 2021, without important challenges. Significant adaptions, however, took place around monitoring activities where specialized research professionals visit hospitals to review the quality of data entered in the study databases compared with data available in the patient charts. This review needs to be in-person, and in Europe it is not allowed to perform these reviews remotely. For this reason, monitoring visits had to be reprogrammed based on the two or three waves of COVID-19 peaks in different countries. For the organization’s operations outside Europe, some countries did allow remote verification of source documents, through innovative remote review systems. Probably most interestingly, the research suggests that the impact of a COVID-19 infection is linked to several cardiac conditions, such as myocardial infarction, stroke, or thrombotic conditions, this required to immediately adapt procedures for timely reporting COVID-19 related clinical events. At ECRI, it has been essential to develop a consistent approach to classify relatedness of procedures or devices to COVID-19, in alignment with the efforts of the European Society of Cardiology, which published in Summer 2020, recommendations for assessment of the interaction between COVID-19 and cardiovascular disease. To ensure that the organization remains at the top of its game, the scientific advisory board was entirely renewed over the last two years. Generational changes are something that the team pay great attention to, and ensure that ECRI remains at the forefront of the industry, so this turnover ensures that the organization can keep moving forward with bold ideas and new concepts at its forefront. This can clearly be seen through the projects that the team have undertaken over the years, perhaps most obviously in the changeover of 2021. 2021 actually represents a point of inflection for the team, with the end of five clinical trials and the start of three innovative projects. These new projects are focused on the high complexity treatment of coronary artery disease. The OPTIMAL trial (NCT04111770), the IVUS CHIP trial (NCT04854070), and the FAST III trial (NCT04931771) are some of the most innovative in their field, pushing ahead with new ideas and concepts that could have a major impact on clinical practice guidelines. The first two projects will generate data that would clarify the role of intravascular ultrasound imaging in the treatment of complex high risk interventions. To provide the right amount of information, the research team are aiming to enrol up to 2800 patients across both projects. These patients will come from seven different European countries. The FAST III trial takes a slightly different tack, utilizing a novel technology to determine the severity of coronary stenosis called vessel Fractional Flow Reserve (vFFR). ECRI runs this study through research grants from two technology companies, Pie Medical Imaging in Maastricht in The Netherlands, and Siemens Healthineers AG, based in Erlangen, Germany. The scope of this impressive project showcases the best of what the team can do, acting as a collaborative effort that includes thirty-five centres in seven European countries. The very nature of ECRI allows it to distinguish itself from other organizations. The institute, by design, focused on the specific needs of cardiologists, with an advisory board includes members who are among the most distinguished academic thought leaders in Europe. As a result, ECRI has become a one-stop-shop for investigator- initiated clinical trials, where grant-givers and investigators can rely on its strengths to manage and monitor the studies. There are very few organizations that can match its reputation for quality, for accuracy and for good solid results. Name: Dr. Ernest Spitzer Email: [email protected] Web Address: www.ECRI-Trials.com

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