UWI20-00-01 Participant Highlight

Dr. Eva M. Vivian, PharmD, MS, PhD

Dr. Vivian is currently Professor at the University of Wisconsin School of Pharmacy. She received her Doctor of Pharmacy degree from the University of Illinois College of Pharmacy, Master of Science from the University of Wisconsin School of Medicine and Public Health, and Doctor of Philosophy from the University of Wisconsin School of Human Ecology. She is certified in diabetes care and education and advanced diabetes management. She currently maintains a practice at Perry Family Free Clinic. Dr. Vivian's research interest focuses on identifying disparities in the treatment of hypertension, diabetes, and other chronic diseases among ethnic minorities, particularly African American and Latino American patients and developing and implementing strategies to reduce and eliminate them. Recently, her research has sharpened its focus in response to heightened awareness of the great numbers of children and adolescents who are at special risk of diabetes.

Dr. Vivian currently serves on the Editorial Board of Diabetes Care. Dr. Vivian has lectured at medical meetings, conferences, and symposia across the United States. Dr. Vivian has held numerous leadership positions within professional associations. She served on the Board of Directors of the American Association of Diabetes Educators during 2011-2013. She is also a member of the American Diabetes Association, American Pharmacy Association, American Association Colleges Pharmacy and American College of Clinical Pharmacy.

Did you hear about clinical trials when you were growing up?

No, my family members, neighbors, and friends did not participate in clinical trials.

How did you first become interested/involved in research professionally?

I became interested in research during my postgraduate residency training at the VAMC San Diego. I assisted an endocrinologist with a clinical trial evaluating the effectiveness of an antidiabetic agent, troglitazone.

Is this the first clinical trial you have participated in?

This is the first clinical trial that I have participated in.

How did you first learn about the STEMVAC trial at the University of Wisconsin?

Dr. Lee Wilke, my oncologist, invited me to participate in the STEMVAC trial. I was happy to participate in a trial that would help my immune system fight cells in my body that could cause breast cancer.

What have you learned about participating in a clinical trial?

Participating in a clinical trial may take more time than anticipated. The study team asks lots of questions about symptoms and other health measures, which is necessary to get information about potential side effects.

What advice would you give others as they consider whether or not to join a clinical trial?

Clinical trials can provide many benefits to study participants and society. However, before volunteering for a clinical trial, you should talk with your health care provider and the study team about the risks and benefits. Take time to think about the time commitment associated with participating in a clinical trial. Don’t hesitate to ask questions about the study procedure and medications used in the clinical trial.

How does it feel to be on the participant side of research/ a clinical trial?

I feel great about being the first participant in the STEMVAC study! Just imagine, the eradication of breast cancer through vaccination. One day breast cancer will be in the same category as smallpox, polio and other diseases that were eliminated through widespread vaccination efforts.

Happy Belated Clinical Trials Day, May 20, 2023

ECRIN, the European Clinical Research Infrastructure Network, “launched International Clinical Trials Day (ICTD) in 2005 to commemorate the day when James Lind started his famous clinical trial on scurvy in 1747, May 20th. By doing so he laid the foundation for modern clinical research. ICTD is the opportunity for research organisations, clinical research professionals, and the public to meet, to acknowledge the achievements that result from clinical research, and to discuss various trial topics. ECRIN’s annual celebration of ICTD brings together international stakeholders from the clinical research community, in Europe and even worldwide. Given its success, the conference has been replicated by some of ECRIN’s member and observer countries, who have now introduced their own national and international ICTD celebrations.”

Organized and promoted by the Association of Clinical Research Professionals (ACRP) since 2014, Clinical Trials Day arrives each May 20 as a joyful opportunity for ACRP Members and other stakeholders in the global clinical research enterprise to pause in reflection, recognition, and admiration of all that has been accomplished by the vast array of professionals and volunteers who are striving to improve public health through medical research or new and improved drugs, devices, and other therapeutics.

ACRP encourages the global clinical trial community to celebrate this great endeavor together by highlighting their shared successes, recognizing patients and providers for their tireless efforts, and promoting to their broader communities the value of clinical research as both a healthcare and career option — moreover, as an under recognized force for public good.

Clinical Trials Day is celebrated around the world in May to recognize the day that James Lind, a ship’s surgeon in the British Royal Navy, started what is often considered the first randomized clinical trial (in this case, to study the effects of different treatments on scurvy in sailors), on May 20, 1774.

Learn more about the history of clinical trials and the clinical research profession:

• Who Was James Lind, and What Exactly Did He Achieve?
• Evolution of Clinical Research: A History Before and Beyond James Lind
• First Clinical Trial in Medicine Changed World History
• The History of Clinical Trials: From James Lind to Nuremburg
• Interested in a Career in Clinical Research? Where to Get Started

DMACC Updates

Data Management and Reporting Unit

Sue Siminski, MS, MBA (Unit Director, DMACC sub-PI), Kayla Denson, PhD, MBA (Unit Co-Manager), Kelly Dunn, MPH, CCRP (Unit Co-Manager), Alex Krolikowski, MS (Training Specialist)

Announcements for LAOs

DMACC recently implemented a process for documenting and completing data corrections. Data entered on the Pre-Screen, Screening, and Enrollment checklists in Stars are directly transferred to Rave. If data on these checklists are entered incorrectly, they cannot be updated by sites; a formal data correction will need to be done by DMACC. If an LAO identifies data that need to be corrected, they should contact DMACC and include the study, Participant ID, question number, original answer, and what the updated answer should be. If a site identifies data that need to be corrected, they should contact their LAO with this information, who should then contact DMACC. DMACC may also identify data corrections during routine data management and/or audits.

DMACC Data Managers will complete a Data Correction Request Form. This form will outline the original data submitter, site and protocol information, method of original data submission (e.g., Stars), and data change request information. This form will be sent to the LAO via email. We ask that the LAO forward this form to the indicated data submitter/site for review. If the information and correction(s) listed are correct, the data submitter (or someone on their behalf at the site) should sign and date the form and return it to DMACC. Once DMACC receives the signed and dated form, the correction(s) will be made. Confirmation of the correction(s) will be sent to the LAO. If there are any questions regarding this process, please contact the DMACC Data Managers at DataManagement_CP-CTNet@frontierscience.org.

System Variable Attribute Report (SVAR) Process and Study Builds in Medidata Rave for New Studies

DMACC continued to work on initial drafts of five SVARs (INT22-09-01, UAZ22-10-01, UAZ22-11-01, 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 one SVAR that is currently in the review process (UMI21-05-01). During the next reporting period, DMACC plans to start an initial draft of one SVAR (NWU22-12-01). Since the last newsletter update, two study builds were pushed to production in Medidata Rave (INT21-05-01 and MDA20-02-01).

A data visualization of DMACC’s real-time, detailed SVAR and study build tracking report is now available to approved Portal Gateway users via the SVAR and Study Build Tracking dashboard item page on the CP-CTNet DMACC Portal Gateway.

Virtual Specimen Repository

The CP-CTNet Virtual Specimen Repository group met in January and March.

The Virtual Specimen Repository application was tested and deployed in January. It is currently being piloted with a limited set of users.

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 export to DMACC in real-time. The LDMS team is working with NWU to set up templates in the LDMS for studies INT21-05-01 (Tri-Ad5/N-803-Lynch Syndrome) and NWU20-02-02 (Atorvastatin-Colon) and with UWI to set up templates in the LDMS for study UWI21-06-01 (Linaclotide-Duodenum).

Meetings

Three Study Initiation Meetings (SIMs) were held for UAZ21-06-01 (BSSE-Lung), NWU20-02-02 (Atorvastatin-Colon), and UMI21-05-01 (OCA-Barrett's Esophagus) in 2023.

Two Cross-Network Collaboration (CNC) meetings were held with LAOs, DCP, and DMACC in January and February.

In follow-up to the last CNC meeting, DMACC sent a list of questions to the LAOs to gather information regarding their current procedures for collecting participant survey and diary data. The goal of gathering this information is to make collection of this data more efficient across the network and reduce data entry burden on accruing LAOs and AOs. Once DMACC clarifies the LAO-specific procedures, capabilities, and workflows for collecting participant-reported outcome (PRO), DMACC will use this information to develop a network-level model for collecting this data using standardized and validated data collection instruments.

Representatives from DCP and DMACC met with the NWU LAO team at Northwestern University (NWU) on March 7, 2023 as part of DCP’s annual LAO site visit.

The CP-CTNet Cross-Network Trials Working Group continued to meet monthly to update CP-CTNet REFGD06 CP-CTNet Cross-Network Trials Guidelines.

Documentation

DMACC released the first CP-CTNet Manual of Standard Operating Procedures (M-SOP) in February, which includes all SOPs that are used in CP-CTNet clinical trials in one PDF portfolio file. The M-SOP also includes a clickable table of contents to allow for quick navigation to specific SOPs. This version of the M-SOP includes CP-CTNet SOPs that were added and updated during a recent annual review of CP-CTNet documentation conducted by DCP and DMACC. DCP and DMACC also completed an annual review of CP-CTNet related documentation (e.g., reference guides, quick reference guides, forms, templates, etc.). The M-SOP and related documentation are available on the Program Resources page on CP-CTNet-DMACC.org.

Educational Content

DMACC offered 23 network-level training sessions to CP-CTNet members since the last newsletter update. Training session topics included the Medidata Rave AQuIP recruitment journal, the AQuIP enrollment trajectory, the protocol deviation reporting and review process in Medidata Rave, grading protocol deviations, the Stars and Medidata Rave enrollment flow, determining CP-CTNet treatment assignments in Stars, the Audit System, Medidata Rave Reports, and the CP-CTNet M-SOP. 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 continued to work with LAOs and DCP to streamline and restructure SIMs by coordinating the development, review, and finalization of the CP-CTNet Study Initiation Meeting Agenda Template. DMACC transitioned the demonstration content from DMACC’s SIM presentations into standalone video tutorials as well. These video tutorials are now available on the Stars, Medidata Rave, and Virtual Training pages on the CP-CTNet DMACC Portal Gateway.

CP-CTNET DMACC Public Website & Portal Gateway

Bob Starkweather, MS (Deputy Director of Software Engineering), David Goss, MA (Software Engineering Business Analyst)

DMACC added a new EDI Resources tab to the Resources page to host Equity, Diversity and Inclusion (EDI) resources to benefit CP-CTNet members. DMACC continued to add and update resources, events, trials, and contact information on CP-CTNet-DMACC.org.

DMACC created the first version of the INT21-05-01 Portal Gateway dashboard item page to post and share cross-network trial resources. DMACC worked with NWU to post all requested INT21-05-01 resources to support trial activities.

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.

Clinical Trials Auditing Unit

Julie Chang, MD (Unit Director), Holly Shaw, MS, CCRP (Unit Co-Manager), Barbara Wollmer, BSN, RN (Unit Co-Manager), Meredith Kissel, MPH (Clinical Trials Auditor)

The Audit Team performed the University of Arizona’s annual LAO audit in January, an onsite audit at Roswell Park Comprehensive Cancer Center in February, an onsite audit at Johns Hopkins University in March, UAZ as an accruing LAO and the University of Wisconsin’s annual LAO audit in April. The Audit Team currently has audit dates planned with MD Anderson (MDA) and the University of Puerto Rico as well. We look forward to our first visit at MDA and meeting this LAO team in person. More audits will be added to the 2023 schedule as studies continue to open and as accruing LAOs and AOs enroll participants. All LAOs and AOs will be given at least six weeks’ notice of our intent to audit.

Holly Shaw and Barbara Wollmer, the Co-Managers of the Clinical Trials Auditing Unit, attended I-SCORE this year. It was great to see so many colleagues from the network in person!

The Audit Team continues to work on improvements and updates to the Audit System.

Members of the DMACC Clinical Trials Auditing Unit and the Administrative and Coordinating Unit met for dinner at Eno Vino Downtown in Madison, WI in late April as well.

Administrative and Coordinating Unit

KyungMann Kim, PhD (Unit Director, DMACC Principal Investigator), Kelly Miller, BS, CCRC (Unit Manager), Bridget Dermody, BS (Administrative Specialist)

The 2023 I-SCORE meeting was a huge success. The hybrid format welcomed 93 in person attendees and 125 virtual attendees. There were close to 20 guest speakers at the event, most of which were in person. We enjoyed an evening of good conversation and camaraderie at Botanero Restaurant after the Thursday meeting activities adjourned. Please visit https://events.cancer.gov/dcp/iscore to view any information about the 2023 I-SCORE meeting.

A huge thanks goes to the planning team members: 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).

DMACC looks forward to working with a new planning team to successfully plan and organize the 2024 I-SCORE meeting.

The DMACC Administrative Unit continues to hold weekly, biweekly, and monthly meetings to continue efficiency and improvements within CP-CTNet.

The 2003 and 2012 Consortia Program resulted in 59 clinical trials in publication. In order to better understand the design characteristics, metrics for trial conduct, and findings from these 59 chemoprevention clinical trials, the DMACC Statistics Subunit has conducted a systematic review with a focus on the hypothesized treatment effect size and sample size estimates given the level a and the power 1-b in collaboration with Drs. Eva Szabo, Leslie Ford, and Vikrant Sahasrabuddhe at the NCI/DCP. A manuscript was recently accepted for publication in Cancer Prevention Research.

If you have questions or comments, please contact us at Admin_CP-CTNet@frontierscience.org.

Research Funding Opportunities

For a list of funding opportunities, check the Funding Opportunities page on CP-CTNet-DMACC.org.

Active and DCP-Approved Studies

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.

Upcoming Events

Meetings and events can be found on the Meetings and Events page on CP-CTNet-DMACC.org.