Clinical Research Innovation

About CRI

A 45-percent increase in cancer diagnoses in the U.S. is expected by 2030. Cancer clinical trials play a crucial role in prevention, early detection, treatment, and, ultimately, cancer cures.

Recognizing that clinical trials in the U.S. face administrative and staffing barriers, regulatory constraints, increasing costs, and lagging patient accrual, AACI established the Clinical Research Initiative (CRI) in 2009, later renaming the program Clinical Research Innovation.

CRI Strategic Plan Goals and Projects

  1. Increase AACI cancer center member participation in CRI and integrate CRI into AACI programs and initiatives
  2. Collect and disseminate benchmarking data to develop and support cancer center clinical trials
  3. Encourage cancer centers to share emerging practices for improving community outreach and engagement in clinical trials
  4. Promote diversity, equity, and inclusion for training and career development
  5. Develop clinical research education, resources, and networks for professional development to continue fostering communication and mentoring opportunities
  6. Increase engagement with industry and other stakeholders to support CRI
  7. Develop financially sustainable models for facilitating efficient and rapid clinical trials office operations

 

The CRI Steering Committee helps guide and implement activities to disseminate best practices across AACI cancer center clinical trials offices.


Chair

Tara L. Lin, MD
The University of Kansas Cancer Center

View All Steering Committee Members

The CRI annual meeting is designed to improve the clinical research process; understand the global impact of conducting clinical research in the United States, Canada, and abroad; discuss trends in clinical trials safety and compliance; and recommend policies to promote staff retention at AACI cancer centers.

View Materials From Past CRI Meetings

CTO Staff Retention Task Force

The COVID-19 pandemic spurred a mass departure from the workforce that has been dubbed the "Great Resignation." This shift has had a significant impact on clinical trials offices (CTOs). In early 2022, AACI’s Clinical Research Innovation (CRI) established a CTO Staff Retention Task Force, led by Dr. Leonidas C. Platanias, director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. The purpose of the task force is to assess the impact of staff retention on AACI cancer centers' ability to open and accrue to clinical trials. The task force distributed a survey in March 2022 and has shared the results with industry members and the National Cancer Institute, as part of a broader conversation on staff turnover and its effects on the availability of clinical trials to patients. The findings revealed common reasons behind staff turnover, which in turn have informed recommendations the task force developed. 

Read the CTO Staff Retention Task Force Recommendations.
Read the September 2022 AACI Commentary.
Read the AACI Clinical Trials Office Staff Retention Task Force 2022-2023 Survey Publication.

CTO Medical Directors Forum

In early 2020, clinical trials office (CTO) medical directors from the AACI CRI Steering Committee created a survey to gather information about the role of the CTO medical director at the cancer centers. In August 2020, after reviewing the survey results, the medical directors found more than half of the survey responders stated they did not have a job description or defined criteria for hiring a new CTO medical director. The medical directors decided to create a job description to aid cancer center leadership when hiring a new CTO medical director or for evaluation of the current medical director. Additionally, the group launched a CTO medical directors listserv to discuss common challenges and solutions. To subscribe to the CTO Medical Director Listserv, you must be a CTO medical director at an AACI cancer center. Please contact AACI Program Coordinator Kendra Cameron to join the listserv and learn about upcoming virtual roundtable meetings.

The CTO medical directors began hosting roundtable meetings with other CTO medical directors in November 2020.  After receiving an enthusiastic response, the CTO medical directors decided to host quarterly virtual roundtable meetings for CTO medical directors to share best practices, discuss ongoing challenges, and—most importantly—mentor new directors. 

CTO Medical Directors Forum Steering Committee
  • Theresa L. Werner, MD, Huntsman Cancer Institute, University of Utah
  • Tara L. Lin, MD, The University of Kansas Cancer Center 
  • Thomas J. George, Jr., MD, FACP, University of Florida Health Cancer Center 
  • Patricia M. LoRusso, DO, PhD, Yale Cancer Center, Yale School of Medicine 
  • Stefan C. Grant, MD, JD, MBA, Wake Forest Baptist Comprehensive Cancer Center 

Past virtual roundtable topics have included the role of the CTO medical director; trial activation, budget, and contract negotiations; managing confidentiality disclosure agreements; site selction and expectations; minority accrual and new Cancer Center Support Grant Community Outreach and Engagement guidelines; and more.

Read the November 2020 Commentary

AACI CRI Education and Operations Subcommittee

To examine the benefits of establishing a common nomenclature to use for regulatory filing systems, AACI established the Regulatory File Management Working Group in October 2018. The working group was comprised of AACI leadership, members from AACI cancer centers, and other relevant stakeholders who work together to create a common cancer clinical trial regulatory file nomenclature.

In 2020, the Regulatory File Management Working Group and Education Workforce Subcommittee were combined and renamed the AACI CRI Education and Operations Subcommittee. The purpose and goals of this subcommittee are to:

  • Address challenges with monitoring staff productivity
  • Establish effort metrics for staff working remotely 
  • Assure timely and accurate data collection 
  • Reopen trials 
  • Conduct trial audits
  • Assess training and onboarding of staff to the CTO

AACI CRI Standard Training Template Checklist
AACI CRI Education and Operations Subcommittee National Recommendations
Read the October 2019 AACI Commentary

Benchmarking Survey

In 2018, the CRI Steering Committee developed a benchmarking survey to learn more about cancer center clinical trials office (CTO) workload, structure, and staffing; trial activation timelines; and sources of CTO funding support. The information was collected to allow AACI members to compare their cancer center with other AACI member centers. The steering committee invited 92 member cancer cancers in the United States and two in Canada that provide clinical care to participate in the survey.  An 11-question survey was distributed in May 2018, closing in January 2019. AACI received 79 responses (86 percent response rate). The survey data were published in JCO Oncology Practice. In spring 2023, the steering committee developed and disseminated a follow-up benchmarking survey to assess CTO structure and workload since the original survey was completed. Survey responses are being collected and will be summarized in a report in fall 2023.

Read Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers





 

Corporate Roundtable Trial Activation Task Force

Cancer centers and pharmaceutical company partners share an interest in opening clinical trials expeditiously. To improve cancer clinical trial operations, the AACI Corporate Roundtable Trial Activation Task Force convened to critically examine the trial activation process and develop best practices to address common barriers to clinical trial activation.

Read the AACI White Paper, Collaboration to Develop Recommendations to Improve Trial Activation Timelines
Read the April 2023 AACI Commentary

Impact of COVID-19 on Cancer Clinical Trials

Over the course of two years AACI CRI Steering Committee members distributed two surveys to assess the impact of the COVID-19 pandemic on clinical trial operations. To share the survey findings, Drs. Thomas J. George, Tara L. Lin, Theresa L. Werner, and 13 past and present steering committee members compiled a report that has been published in JNCI Cancer Spectrum

Read Quantifying the Impact of the COVID-19 Pandemic on Cancer Center Clinical Trial Operations