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.  

The first AACI CRI Annual Meeting took place in 2009 with fewer than 200 attendees. By 2019, attendance exceeded 430 with 13 exhibitors and 64 posters on display. In 2020, the first virtual CRI meeting drew over 1,000 registrants.

View the CRI Progress Report

Strategic Plan & Goals

  1. Increase AACI cancer center participation in CRI
  2. Share cancer center clinical trial best practices through the collection and dissemination of benchmarking data
  3. Integrate CRI into AACI programs/initiatives
  4. Assist the centers in increasing patient engagement and enrollment into clinical trials 
  5. Develop outcomes to drive change and advance cancer center clinical research programs
  6. Increase engagement with industry and other stakeholders to support CRI
  7. Create a network for clinical trials office medical and administrative directors to foster 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
Theresa L. Werner, MD
Huntsman Cancer Institute, University of Utah

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 the Digital Meeting Program
Register for the 13th Annual AACI CRI Meeting
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 cri@aaci-cancer.org.

Working Groups & Surveys

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

Regulatory File Management Working Group

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 is comprised of AACI leadership, members from AACI cancer centers, and other relevant stakeholders who are working together to create a common cancer clinical trial regulatory file nomenclature.

Goals:

  • Identify the challenges associated with non-standardized nomenclature

  • Develop standard nomenclature for trial regulatory use

  • Develop a site map for storing common documents

  • Share best practices for site monitoring
     

Read the October 2019 AACI Commentary


Benchmarking Survey

The CRI Steering Committee invited cancer centers to participate in 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 is to allow cancer center members to compare their center with other AACI members.

Eighty-six percent of elgible centers responded to the survey. Data analysis is underway. The next steps will be to send back summary data reports to participating centers and prepare data for publication. 

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