CTO excels in recent audits and advances in cancer clinical trials
July 24, 2024
The University of Hawaiʻi Cancer Center Clinical Trials Office (CTO) has excelled in recent audits by both Southwest Oncology Group (SWOG) Cancer Research Network, which is part of the nation's oldest and largest publicly funded cancer research network; and Alliance for Clinical Trials in Oncology, a national clinical trials network sponsored by the National Cancer Institute.
"Successful audits show that the Hawaiʻi Cancer Consortium is conducting high-quality research for our community," said Erin Fukaya, Clinical Operations Manager. "We can be confident that we are contributing good data that could potentially lead to the approval of more cancer therapies in the future."
Clinical trials are research studies that test new medical approaches in people. As of July 19, 2024, the UH Cancer Center is actively enrolling patients in 103 of their clinical trials conducted in cooperation with the Hawaiʻi Cancer Consortium, 77 of which are interventional studies.
The SWOG audit, held from April 9-12, 2024, praised the UH Cancer Center for significant improvements. Twenty-nine patient cases were reviewed, and only three major issues were identified, marking a notable improvement over previous audits. Similarly, the Alliance audit on June 25-26, 2024, yielded no findings in the regulatory, pharmacy, or patient case review, highlighting the Clinical Trials Office's advancements in clinical trial operations and data maintenance and securing a three-year approval status.
"These audits will contribute to our goal: reducing the burden of cancer within our community, by improving our clinical trial services," said Dr. Toshiaki Iwase, Medical Director of the Clinical Trials Office. "Through the audit process, we successfully improved our clinical trial operation and the quality of data maintenance."
After the previous audits, the Clinical Trials Office was tasked with addressing the Corrective and Preventive Action (CAPA) plan. Implementing the plan came with challenges, as the center is part of a diverse network of hospitals and clinical partners. Close collaboration between the Clinical Trials Office, partner sites, and compliance team was vital in overcoming these challenges and streamlining clinical trial operations.
Following the latest audits, the Clinical Trials Office's successes were recognized in the SWOG newsletter, The Front Line, under the "Member Highlight: Hawaiʻi Minority/Underserved-NCI Community Oncology Research Program (MU-NCORP)" section. The feature commended the UH Cancer Centerʻ's leadership in promoting diversity and accessibility in cancer clinical trials across Hawaiʻi's diverse population.
"SWOG and Hope (The Hope Foundation for Cancer Research) are proud to support such efforts, and we're even prouder to have members like the Hawaiʻi MU-NCORP, which so clearly exemplify the NCI's (National Cancer Society) NCORP's mission of bringing cancer clinical trials and care delivery studies to people – all people – in their communities," The Front Line article said.
The UH Cancer Center and Hawaiʻi Cancer Consortium are actively involved in NCORP, which aims to bring cancer clinical trials and studies on care delivery directly to communities, through a Hawaiʻi MU-NCORP grant led by Drs. Jeffrey Berenberg, Jared Acoba, and Christa Braun-Inglis, clinical trials are conducted through the NCI National Clinical Trials Network.
The Hawaiʻi MU-NCORP, comprising 24 affiliated sites, continues to play a crucial role in advancing cancer care delivery and research initiatives, reinforcing the center's dedication to enhancing cancer care for all community members.