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: Thomas J. George, Jr., MD, FACP, FASCO
University of Florida Health Cancer Center

View All Steering Committee Members

Save the Dates

17th Annual AACI CRI Meeting 
June 23-25, 2025
Loews Chicago O'Hare Hotel
Rosemont, IL

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 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 Manager 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 
  • Stefan C. Grant, MD, JD, MBA, Louisiana Cancer Research 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

The purpose and goals of the AACI CRI Education and Operations 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
The subcommittee compiled a list of competencies and created a standardized training module to help fill gaps for oncology research staff. The first two topics chosen were good documentation practices with the ALCOA+ principles and protocol deviations. The subcommittee members were divided into groups that developed customizable competency templates on their respective topics. Cancer centers can use them to assess the understanding of these two topics at their respective centers when onboarding and training staff. Please contact Programs Manager Kendra Cameron to request these templates in PowerPoint (.PPT) format.

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. In spring 2023, the steering committee disseminated an updated benchmarking survey to assess contemporary CTO structure, performance, and capacity since the original survey was completed. Both sets of survey data were published in JCO Oncology Practice. The steering committee will continue to readminister the survey annually to help centers compare and track growth of their CTOs.

Read the 2018 publication: Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers
Read the 2023 publication: North American Cancer Center Clinical Research Capacity and Benchmarking in the Postpandemic Era
 

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.

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