Sending you warm holiday greetings and best wishes for a bright new year. Happy holidays!
What sparked your interest, and how long have you been involved with clinical research?
I was introduced to cancer prevention research by one of the legends in the field, Dr. David Alberts. I have been involved in clinical and translational cancer prevention research for over 20 years.
What is your role in the CP-CTNet program?
I am the contact PI of the University of Arizona Cancer Prevention Clinical Trials Network.
What challenges/advantages do you see within the CP-CTNet program and how have you overcome them?
The CP-CTNet program offers the unique funding mechanism and infrastructure to support the conduct of early phase clinical trials of cancer preventive agents. These are critical trials for clinical development of cancer preventive agents to impact the clinical practice in cancer prevention. As any new program, there are growing pains in navigating the processes within the program. We have learned to compartmentalize the challenges and have worked with many dedicated individuals to help us overcome these challenges.
What advice do you have for other members of CP-CTNet who share your job title/responsibilities?
We have a very collegial group of network PIs. We are all willing to share our insights and experience to support the overall success of the CP-CTNet program.
Who are your staff involved with CP-CTNet and what are their roles for the network?
I lead our network with the support from my MPI, Dr. Julie Bauman. Dr. Paul Hsu provides the statistical support for our network. We are supported by a team of dedicated staff which include Ms. Amy Selegue for management of our network, Ms. Dianna Gilmore for management of our budgets and subawards, Ms. Bonita Weible for regulatory oversight, Ms. Amy Carrier for oversight of clinical trial activities, Mr. Jose Guillen for data management, Ms. Laura Duckett, Frances Epstein, Susana Chavez for study coordination, and Ms. Catherine Cordova for specimen management.
Where did you go to college?
I was born and raised in Taiwan. I went to Taipei Medical College for my undergrad and SUNY Buffalo for my graduate work.
What are your hobbies/interests out of work?
I enjoy traveling with my family and trying new recipes.
What is the best advice you have ever been given?
I am not sure about the best advice, but I would like to share my favorite quote “Prevention is so much better than healing because it saves the labor of being sick.”
During this quarter, DMACC continued to work on initial drafts of three SVARs (INT22-09-01, UMI22-09-01, and UMI22-09-02) and plans to finalize these initial drafts to send to the LAOs for review soon. DMACC also continued to make progress on two SVARs that are currently in the review process (UMI21-05-01 and UWI20-04-01) and finalized one SVAR (INT21-05-01). During the next quarter, DMACC plans to start initial drafts of two additional SVARs (UAZ22-10-01 and UAZ22-11-01). Since September, one study build has been pushed to production in Medidata Rave (UAZ21-07-01). Work is ongoing on three study builds, with two on track to be completed by the end of December (INT21-05-01 and MDA20-02-01).
A data visualization of DMACC’s real-time, detailed SVAR and study build status report has been developed and work is underway to share this visualization with the LAOs via a dashboard item page on the CP-CTNet DMACC Portal Gateway.
The CP-CTNet Virtual Specimen Repository group met in September and November.
The Virtual Specimen Repository application was tested and is projected to be deployed in December 2022.
Laboratory Data Management System (LDMS) inventory data from UAZ and NWU for studies UAZ20-01-01 (Apalutamide-Prostate), UAZ21-06-01 (BSSE-Lung), and NWU20-02-01 (Metformin/Megestrol-Endometrium) continue to funnel to DMACC in real-time.
During the September Virtual Specimen Repository meeting, DMACC presented a prototype for a sample expectancy report which captures expected sample collection vs. actual sample collection. The feedback that was received included suggestions to enhance and update the report, as well as other ideas for participant-level tracking report(s). The UAZ20-01-01 report was deployed to production in October 2022 and will be utilized and shared (as appropriate) by Data Management staff beginning in December 2022. Additional reports are being developed for UAZ21-06-01 and NWU20-02-01.
The inaugural CP-CTNet Cross-network Trials Data and Safety Monitoring Board (DSMB) meeting was held on October 11th, 2022. The INT21-05-01 and INT22-09-01 studies were introduced during this meeting. The DSMB will meet annually and as needed as per protocol requirements.
DMACC met with DCP and the LAOs involved in the INT21-05-01 trial on October 13th, 2022 to gather feedback on the prototype of the study-specific dashboard item page, which is designed to facilitate the sharing of study resources between LAOs and AOs.
A Cross-Network Collaboration (CNC) call was held on November 2nd, 2022.
In response to feedback received from LAOs and AOs, CP-CTNet is moving the current network Standard Operating Procedures (SOPs) into a manual of all network SOPs under one umbrella document, referred to as a Manual of Standard Operating Procedures (M-SOP). The M-SOP includes all the SOPs for the network and will be updated three times a year to alleviate constant SOP updates. CP-CTNet members can expect to receive the first version of the M-SOP in early 2023.
DCP and DMACC also collaborated to complete an annual review of all CP-CTNet SOPs and related documentation. These SOPs are being incorporated into the M-SOP. All updated related documents (e.g., reference guides, quick reference guides, forms, templates, etc.) will be available soon on the Program Resources page on CP-CTNet-DMACC.org.
DMACC created three quick reference guides to support the use of the Audit System which are now available on the Program Resources page on CP-CTNet-DMACC.org. The quick reference guides include QKREFGD09 Audit System Overview for LAOs and AOs, QKREFGD10 Audit System Overview for Reviewers, and QKREFGD11 Audit System Overview for Approvers.
DMACC offered 12 network-level training sessions and two site-specific training sessions to CP-CTNet members during this quarter. Training session topics included the Medidata Rave AQuIP recruitment journal, the protocol deviation reporting and review process in Medidata Rave, the Stars and Medidata Rave enrollment flow, determining CP-CTNet treatment assignments, and the Audit System. To see a list of upcoming live trainings and to register, go to the Training Registration page on the CP-CTNet DMACC Portal Gateway.
DMACC finalized and posted three new video tutorials and associated transcripts to guide the process of reporting and reviewing protocol deviations in Medidata Rave for LAOs, AOs, and DCP. These video resources are available on the Medidata Rave and Virtual Training pages on the CP-CTNet DMACC Portal Gateway. DMACC is working with LAOs and DCP to streamline and restructure the Study Initiation Meetings (SIMs). As part of this effort DMACC is creating a CP-CTNet SIM agenda template and is transitioning the demonstration content from DMACC’s SIM presentations into standalone video tutorials which will be available on the Stars, Medidata Rave, and Virtual Training pages on the CP-CTNet DMACC Portal Gateway.
The Website Review Committee met in October and December.
DMACC updated CP-CTNet-DMACC.org to include dropdown navigation functionality, a redesigned Trials page, an online format for the CP-CTNet DMACC newsletters, and streamlined mobile navigation. In addition, DMACC continued to add and update resources, events, trials, and contact information on the public website.
A variety of minor technical, user interface, and performance enhancements have been made to the CP-CTNet DMACC Portal Gateway to improve the user experience for CP-CTNet members. The trial-specific electronic case report form (eCRF) completion guides are now hosted on the Document Library page. Many links and resources have been updated on the CP-CTNet DMACC Portal Gateway as well.
DMACC worked with the LAOs to develop an INT21-05-01 dashboard item page to post and share cross-network trial resources. The INT21-05-01 dashboard item page is projected to be available when the study and first site(s) are activated. This dashboard item page will serve as a model to develop additional dashboard item pages for other cross-network trials.
DMACC continued to explore more data visualization options and reports that will be added to the CP-CTNet DMACC Portal Gateway to monitor study progress and key metrics.
The Audit Team hosted a webinar on October 18th, 2022 that provided tips for preparing for quality assurance audits and LAO oversight. The presentation used during this webinar is available on the Audit System page on the CP-CTNet DMACC Portal Gateway.
The auditing criteria algorithm has been updated by DMACC and approved by DCP. Under the new algorithm, accruing LAOs and AOs will be eligible for audits once a site accrues a minimum of three participants to a specific protocol. In addition, the participant case review parameters have been updated to state that a minimum of three participant charts per protocol/per site will be reviewed during each DMACC quality assurance audit. These criteria changes represent a move to a protocol-based model and allow DMACC to focus on a specific study team and their protocols, conduct risk appropriate auditing based on accrual and protocol risk level, and conduct audits earlier in the study. DMACC and DCP are working on updating the audit documentation to reflect these updates.
The Audit Team recently performed an onsite audit at USC Norris Cancer Center for UAZ20-01-01: Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy. The University of Arizona’s annual LAO audit is scheduled for January 2023. More audits will be added to the 2023 schedule as studies continue to open and as accruing LAOs and AOs enroll participants.
The Audit Team is also participating in monthly calls with DCP and CCSA to streamline SharePoint searching and regulatory document sharing.
The Audit System application is continuing to evolve in support of DMACC quality assurance audits. The current release features continued technical backend improvements, improved user input validation/error handling, and miscellaneous audit form and audit report enhancements requested by the Audit Team. This version was released in November 2022.
Our team continues to disseminate important information to the greater CP-CTNet audience via email and updates on CP-CTNet-DMACC.org, and to provide administrative and coordinating support to CP-CTNet.
The I-SCORE 2023 Planning Committee has started brainstorming for the March 30-31, 2023 meeting which will be held in Rockville, MD for the first time since 2019. The meeting also plans to offer a virtual option to expand the reach of the meeting to those unable to attend in person. The planning team members are Dr. Asad Umar (NCI), Dr. Howard Bailey (UW-Madison/UWI), Dr. Brian Cholewa (NCI), Lisa Bengtson (NCI), Mela Asefa (NCI), Perquita Perry (NCI), Rodshae Garvey (NCI), Kelly Miller (UW-Madison DMACC), Avery Whitbeck (UW-Madison DMACC), and Bridget Dermody (UW-Madison DMACC).
We welcome Avery Whitbeck to the DMACC at UW-Madison. She joined our team in October 2022. She will be assisting the Administrative and Coordinating Unit of the DMACC by keeping everyone organized so be on the lookout for Doodle Polls, calendar invites and other emails (draft agendas/minutes, staff directory updates) from her. She’s an undergraduate student at the University of Wisconsin-Madison School of Nursing. She has a deep interest in global health, research and statistics and has even taken a biostatistics course already! She’s gained valuable skills in taking care of patients and has a keen eye for detail. We are very fortunate to have her join our team and can’t wait for her to learn more about all the research we are involved in and all the staff members in CP-CTNet.
With sadness, we note the sudden passing of Zhumin Zhang, MS (Statistics), PhD (Nutritional Sciences), a biostatistician at the University of Wisconsin-Madison Department of Biostatistics and Medical Informatics, who died on Thursday, November 10, 2022. She worked with Dr. KyungMann Kim and his team on projects for the Cancer Prevention Clinical Trials Network (CP-CTNet) Data Management, Auditing and Coordinating Center (DMACC).
For a list of funding opportunities, check the Funding Opportunities page on CP-CTNet-DMACC.org.
A list of active and DCP-approved studies is available on the Trials page on CP-CTNet-DMACC.org. Each trial includes the title, status, DCP ID, and a link to a trial-specific information page once trial information is available on clinicaltrials.gov.
Meetings and events can be found on the Meetings and Events page on CP-CTNet-DMACC.org.