PURPOSE Cancer center clinical trial offices (CCTOs) support trial development, activation, conduct, regulatory adherence, data integrity, and compliance. In 2018, the Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) Steering Committee conducted and published survey results to benchmark North American CCTOs, including trial volume, accrual, full time equivalents (FTEs), and budget. The survey was readministered in 2023 to assess contemporary CCTO performance and capacity with results presented here. METHODS The 28 question 2023 survey was sent to directors of AACI's clinical member cancer centers. Survey participation was voluntary, no compensation was provided, and data requested covered operations during 2022. Definitions were consistent with National Cancer Institute (NCI) CCTO reporting requirements and AACI staff anonymously compiled results for descriptive statistical reporting. RESULTS The survey response rate was 61% (60/99). The median annual CCTO budget was $11.5 million (M) US dollars (USD) versus $8.2M USD in 2018. These budgets support a median of 150 FTEs versus 104 previously, and a median total of 384 versus 280 interventional treatment trials and a median of 479 versus 531 interventional treatment accruals. Sources of support for CCTO annual budgets were primarily from industry revenue (45.3%) or institutional support (31.7%). Nearly 60% of centers reported activating NCI-sponsored studies within 90 days but only 9% reported meeting a 90-day activation timeline for industry sponsored studies. CONCLUSION Contemporary benchmarks for CCTO operations through this survey demonstrate larger staff sizes, larger budgets, more trials supported, but fewer patients enrolled to interventional treatment trials in comparison with 2018. These data shine a critical light on the increasing complexity of cancer clinical trials, the importance of external funding sources, and necessary operational efficiency upgrades to provide cutting-edge cancer research and care.

e13566 Background: An integrated cancer service line (CSL) in academic medical centers provides a patient-centered approach with the goals of improving the patient experience and clinical outcomes; managing financial operations; increasing access to clinical research; and decreasing health disparities. The Association of American Cancer Institutes (AACI) Physician Clinical Leadership Initiative Steering Committee sought to evaluate the current state of cancer services lines among the membership of AACI to identify common areas of organizational structure and function and potential areas for enhancing integration. Methods: A 29-question, mixed-methods, descriptive survey with multiple choice and short answer questions addressing the characteristics of the center’s CSL, was sent electronically to the cancer center directors and administrators at 107 academic centers on July 31, 2023, and again on August 24, 2023. Descriptive statistics were used to summarize the survey data. Results: Of 107 centers, 75 (70%) responded to the survey. Of the 68 respondents with clinical services, 58 centers (85%) had a defined CSL. Twenty-three centers (40%) noted that they did not have a formal charter defining governance and structure; 11 (48%) of the 23 are National Cancer Institute (NCI)-Designated Cancer Centers. Twenty-six (45%) reported a defined funds flow. Fifty (86%) cancer centers have a physician as a primary leader and the majority have a leadership team of two or more individuals (55, 95%). While hematology and medical oncology, radiation oncology, and surgical specialties were part of every CSL, pathology (31, 53%) and radiology (28, 48%) were included in only half of the centers. Center respondents noted that quality and safety were a primary focus (48, 83%), with regional growth (45, 78%), ambulatory operations (44, 76%), and budgeting and margin management (43, 74%) as additional responsibilities. Key performance metrics tracked by the CSL included the number of new patients (57, 98%), time to first appointment (55, 95%), and accrual to clinical trials (47, 81%), while 48% (28) tracked palliative care referrals within 90 days of death. Most CSL services, inclusive of records collection (86%), billing (86%), and coding (81%) are centralized within the center’s health system. Conclusions: There is widespread variability in the structure of academic CSLs with 40% and 55% of respondents not having a formal charter or funds flow, respectively. Leadership, key responsibilities, and metrics differed across centers. These results can serve as a tool for centers to refine their existing CSL or as a guide for CSL development. Our survey highlights a potential to evaluate CSL structures, which are inclusive of a broader series of departments and services, to determine the optimal approach for a multidisciplinary patient-centered care model. Efforts to obtain outcome data on CSL structures are warranted.

105 Background: Decentralized clinical trials (DCT) involve conducting some or all trial-related activities at a location separate from the investigator's site. DCT can help reduce the burden on patients, sites, and sponsors while improving patient accrual and retention rates and increasing the diversity of trial participants. While DCT methods provide patient-centric trial flexibilities, they can impact trial operations. This survey aimed to gain insights into the perspectives and experiences of cancer centers regarding DCT in the field of oncology. Methods: A 13-question survey that addressed prior experience, perceived benefits, and challenges in implementing DCT was developed by members of the Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) Steering Committee. The survey was sent via email to the AACI CRI listserv, which consists of members of 90 cancer research centers in North America. Respondents were asked to consider their activity related to treatment and non-treatment interventional trials. Results: There were 75 total responses from members affiliated with 55 individual cancer centers. Of these centers, 73% were NCI-designated cancer centers. Of the individual respondents, 57% were clinical trial office administrators. The issues of highest concern by respondents were 1) meeting study timelines, 2) patient recruitment and 3) cost (83%, 65%, 44% respectively). All respondents had prior experience with DCT tools with the most common components being the use of local facilities for labs/imaging, telemedicine and e-consent (89%, 69%, 68% respectively). The areas of most perceived benefit from DCT include reduced participant burden, increased diversity and participant retention (81%, 80%, 68% respectively) while areas of perceived challenges include quality control, regulatory compliance and cost (61%, 59%, 49% respectively). While 92% respondents agreed/strongly agreed that DCT can improve clinical trial access, 92% agreed/strongly agreed that additional site staff training is required for successful DCT implementation. Conclusions: DCT tools have been widely implemented in oncology trials with all surveyed sites reporting prior experience. This survey emphasizes the perceived benefits of DCT in oncology, while underscoring the importance of addressing challenges and meeting the specific requirements of cancer centers. Future work should identify specific areas that require additional staff training to enable DCT readiness.

Background Oncology clinical trials are complex, and the COVID-19 pandemic caused major disruptions in 2020.Methods Using its networking and sharing of best practices, the Association of American Cancer Institutes, comprising 105 cancer centers, solicited a longitudinal series of voluntary surveys from members to assess how clinical trial office operations were affected. The surveys showed that centers were able to keep oncology trials available to patients while maintaining safety. Data were collected regarding interventional clinical trial accruals for the calendar years 2019, 2020, and 2021.Results Data demonstrated a sizeable decrease in interventional treatment trial accruals in both 2020 and 2021 compared with prepandemic figures in 2019. No cancer center reported an increase in interventional treatment trial accruals in 2020 compared with 2019, with most centers reporting a moderate decrease. In mid-2022, 15% of respondents reported an increasing trend, 31% reported no significant change, and 54% continued to report a decrease.Conclusions The pandemic necessitated rapid adoption of trial operations, with the emergence of several best practices, including remote monitoring, remote consenting, electronic research charts, and work-from-home strategies for staff. The national infrastructure to conduct trials was significantly affected by the pandemic, with noteworthy resiliency, evidenced by improvements in efficiencies and patient-centered care delivery but with residual capacity challenges that will be evident for the foreseeable future.

PURPOSE: The 21st Century Cures Act mandates the immediate release of clinical information (IRCI) to patients. Immediate sharing of sensitive test results to patients with cancer might have serious unintended consequences for patients and providers. METHODS: A 22-question REDCap survey was designed by the Association of American Cancer Institutes Physician Clinical Leadership Initiative Steering Committee to explore oncology providers' opinions on IRCI policy implementation. It was administered twice in 2021 with a 3-month interval. A third survey with a single question seeking providers' opinions about their adaptation to the IRCI mandate was administered 1 year later to those who had responded to the earlier surveys. The data were analyzed using descriptive statistics such as chi-squared or Fisher's exact tests for categorical variables. The survey was sent to all Association of American Cancer Institutes cancer center members. In the first or second administration, 167 practitioners answered the survey; 31 responded to the third survey. RESULTS: Three quarters of the providers did not favor the new requirement for IRCI and 62% encountered questions from patients about results being sent to them without provider interpretation. Only half of the hospitals had a plan in place to deal with the new IRCI requirements. A third survey, for longitudinal follow-up, indicated a more favorable trend toward adoption of IRCI. CONCLUSION: IRCI for patients with cancer was perceived negatively by academic oncology providers after its implementation. It was viewed to be associated with higher levels of patient anxiety and complaints about the care delivered. Providers preferred to discuss test results with patients before release.