The Impact of a National Cyberattack Affecting Clinical Trials: The Cancer Trials Ireland Experience.

PURPOSE: Cyberattacks are increasing in health care and cause immediate disruption to patient care, have a lasting impact, and compromise scientific integrity of affected clinical trials. On the May 14, 2021, the Irish health service was the victim of a nationwide ransomware attack. Patient care was disrupted across 4,000 locations, including 18 cancer clinical trials units associated with Cancer Trials Ireland (CTI). This report analyses the impact of the cyberattack on the organization and proposes steps to mitigate the impact of future cyberattacks. METHODS: A questionnaire was distributed to the units within the CTI group; this examined key performance indicators for a period of 4 weeks before, during, and after the attack, and was supplemented by minutes of weekly conference call with CTI units to facilitate information sharing, accelerate mitigation, and support affected units. A total of 10 responses were returned, from three private and seven public hospitals. RESULTS: The effect of the attack on referrals and enrollment to trials was marked, resulting in a drop of 85% in referrals and 55% in recruitment before recovery. Radiology, radiotherapy, and laboratory systems are heavily reliant on information technology systems. Access to all was affected. Lack of preparedness was highlighted as a significant issue. Of the sites surveyed, two had a preparedness plan in place before the attack, both of these being private institutions. Of the eight institutions where no plan was in place, three now have or are putting a plan in place, whereas no plan is in place at the five remaining sites. CONCLUSION: The cyberattack had a dramatic and sustained impact on trial conduct and accrual. Increased cybermaturity needs to be embedded in clinical trial logistics and the units conducting them.

Prevention and management of adverse events related to regorafenib.

Regorafenib is an oral multikinase inhibitor that has shown antitumor activity in a range of solid tumors. Based on data from phase III clinical trials, regorafenib is indicated for the treatment of adult patients with metastatic colorectal cancer who have previously been treated with, or are not considered candidates for, other available therapies, and in patients with advanced gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other appropriate treatments. A panel of oncology nurses, research coordinators, and other medical oncology experts, experienced in the care of patients treated with regorafenib, met to discuss the best practice for the management of regorafenib-associated adverse events (AEs). The panel agreed that, in clinical trials and daily practice with regorafenib, AEs are common but mostly manageable. The most common and/or important AEs associated with regorafenib were considered to be hand-foot skin reaction, rash or desquamation, stomatitis, diarrhea, hypertension, liver abnormalities, and fatigue. This manuscript describes the experience and recommendations of the panel for managing these AEs in everyday clinical practice. Appropriate education, monitoring, and management are considered essential for reducing the incidence, duration, and severity of regorafenib-associated AEs.