Virtual Summit

The SITC Crisis in Clinical Research Virtual Summit was a successful initial step in addressing the crisis in clinical research that brought oncologists, administrators, the NCI, the FDA, pharmaceutical companies, contract research organizations, and other major oncology professional organizations together to further delineate the current staffing and administrative issues for oncology clinical trials. The group also considered alternative clinical trials administrative models to reduce the current burden.

Finding solutions to address current clinical trials staffing issues will be imperative for optimal patient care, advancing drug development, and maintaining financial feasibility of academic medical centers.

Attendees were able to:

• Hear vital perspectives from leading experts from academic medical centers, major community cancer centers, contract research organizations, the FDA, and the NCI detailing the crisis
• Listen to panel discussions on the most significant hurdles facing clinical trial administration
• Get involved in the discussion through chat functionality

RECORDING & PANELISTS

Summit Overview

Problem Statement

There is a national crisis slowing clinical research due to staffing shortages, administrative burden and current clinical trial business models. If the crisis is not rapidly addressed, the field of oncology faces a significant threat to patient treatment access and novel drug development that can affect the clinical landscape for years to come.

SITC’s Call to Action and Summit Overview

Based on preliminary discussions with various stakeholders concerning the significance of the crisis, The Society for Immunotherapy of Cancer (SITC) hosted the Crisis in Clinical Research Virtual Summit on Wednesday, Aug. 17, from 10:00 a.m.–3:30 p.m. EDT. The summit was designed as a free, public event that featured expert panel discussions, invited speakers, and attendee question and answer periods. In all, the multi-stakeholder virtual summit convened over 600 attendees and 30 panelists demonstrating the critical need across the field for solutions pertaining to the crisis. Attendees included oncologists, administrators, the National Cancer Institute (NCI), the US Food and Drug Administration (FDA), pharmaceutical companies, contract research organizations (CRO) and other major oncology professional organizations.

Summit Goals

The summit’s primary objective was to define actionable solutions towards addressing the current staffing shortages, administrative issues and process inefficiencies facing oncology clinical trials, as well as consider alternative clinical trials administrative models to reduce the current burden.

Professional Roles of Attendees

*Attendees allowed to select multiple roles

Fireside Chat with Dr. Hwu, Dr. Emens, and Dr. Sznol

Summit Outcomes and Next Steps

Summit Takeaways

Summit attendees formalized possible solutions towards addressing the crisis and clinical research inefficiencies throughout the program. At the conclusion of the meeting, SITC was provided four key efforts that would create momentum in this arena:

SITC’s Next Steps

As a direct followup to this impactful summit, SITC is actively working with volunteers on formulating direct actions to address the four identified efforts. Immediately, published works are in development to provide awareness to the current crisis as well as to provide expanded insight concerning summit conclusions. Additionally, SITC has emphasized collaboration as a critical element of effective response to the crisis and is actively communicating with like‐minded groups towards developing impactful solutions. Overall, SITC is committed to serving as a leader in addressing the crisis facing clinical research. Further information on how the attendees came to these recommendations can be found below in a detailed report of each talk and panel that occurred throughout the summit.

Summit Organizers

• Leisha Emens, MD, PhD – Co-Chair
  UPMC Hillman Cancer Center
• Mario Sznol, MD – Co-Chair
  Yale University
• Marc Ernstoff, MD
  National Cancer Institute
• Michael S. Gordon, MD
  HonorHealth
• David Hong, MD
  MD Anderson Cancer Center
• Krystyna Kowalczyk
  OncoBay
• Stephanie Terzulli, PhD
  Memorial Sloan Kettering Cancer Center
• David Feltquate, MD, PhD
  Palleon Pharma 
• Marc Theoret, MD
  US Food and Drug Administration
• Kristin Hege, MD
  Bristol Myers Squibb

Clinical Research Resources

FDA Guidance

• Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring
• Electronic Source Data in Clinical Investigations
• Use of Electronic Informed Consent Questions and Answers
• Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry
• Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
• Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision Making for Drug and Biological Products
• Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
• Oncology Center of Excellence

Administration and Staffing Resources

• The Critical Need for Academic Health Centers to Assess the Training, Support, and Career Development Requirements of Clinical Research Coordinators

Other Resources

• Direct Data Extraction and Exchange of Local Labs for Clinical Research Protocols: A Partnership with Sites, Biopharmaceutical Firms, and Clinical Research Organizations