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. 

In late 2018, to mark its success and benefits to members, the program was renamed Clinical Research Innovation.  
 

2022 Strategic Plan & Goals

  1. Increase AACI cancer center participation in CRI
  2. Collect and disseminate benchmarking data to develop cancer center clinical trial best practices
  3. Integrate CRI into AACI programs and initiatives
  4. Assist cancer centers in improving community outreach and engagement to increase enrollment in clinical trials
  5. Promote diversity, equity, and inclusion for training and career development
  6. Develop clinical research education and resources for professional development
  7. Increase engagement with industry and other stakeholders to support CRI
  8. Develop outcomes to drive change and advance cancer center clinical research programs
  9. Create a network for leadership to continue fostering communication and mentoring opportunities

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

The CRI Listserv engages over 750 subscribers from 85 of AACI's member centers. The listserv is an efficient platform for AACI members to ask questions, receive immediate feedback, and share institutional policies and clinical trial operational best practices.

Examples of past listserv topics include:

  • Cancer center staff access to standard operating procedures (SOPs)
  • Managing amendments during study start-up
  • Pharmacists and delegations of authority log
  • Remote monitoring
  • Team structures (ex. regulatory, quality assurance)

The listserv is open only to AACI cancer center members. To join the listserv, please send your request to [email protected].

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.

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 purpose of collecting this information was 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 the JCO Oncology Practice.

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

AACI SIP Task Force

This task force is facilitating collaboration with industry partners to help AACI member cancer centers implement the Shared Investigator Platform (SIP) for clinical trials.

Read the August 2019 AACI Commentary