Crisis in Clinical Research

Crisis in Clinical Research


The Society for Immunotherapy of Cancer (SITC) is convening key oncology experts from academia, industry and government, including the FDA and NCI, to lead a national conversation around what’s become a crisis in clinical research.

Through discussions with key stakeholders in academia, industry, and government, it has become apparent that this crisis is having a significant negative impact on cancer drug development and patient care, which threatens advancement of the field for years to come. Leveraging its convening powers, SITC is leading the national conversation around this crisis and is committed to finding collaborative solutions that ultimately reduce the administrative burden of clinical trials while increasing patient access to safe and effective clinical trials.

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

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

SITC Presidents Dr. Mario Sznol (2019-2020), Dr. Patrick Hwu (2021-2022) and Dr. Leisha Emens (2023-2024) provide an overview of the Crisis in Clinical Research and SITC's role in addressing the ongoing challenges in this 2022 SITC Annual Meeting Update Session. Discussions include how staffing and inefficiencies in clinical research are limiting advancement of critical therapies and how SITC will work to continue advocacy and collaborative outreach to achieve field-wide solutions.

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:

Standardization and Centralization of Clinical Research Resources

  • Develop consensus on structured data inputs
  • Standardize clinical research contracting and budgeting language
  • Adopt standard timelines across the field for implementation of EDC automations
  • Implement consistent EMR builds and compatibilities
  • Incorporate and accept centralized IRBs and SRCs

Cross-institutional Data Availability

  • Collect clinical research accrual and activation data to drive future innovation
  • Expand upon current data collection efforts
  • Promote impartial and accepted data sharing culture across institutions and stakeholders

Maximizing Efficiency Across Clinical Research Operations

  • Embrace automation
  • Incorporate business‐like operations within clinical research workstreams
  • Perform work in parallel towards identifying potential efficiencies/inefficiencies
  • Reduce silo’s and streamline communications across stakeholders
  • Develop processes that maximize personal and professional success for the available workforce

Diversification of Clinical Research Sites and Populations

  • Expand access of clinical trials to underrepresented communities
  • Increase patient education towards enhancing clinical trial acceptance
  • Provide education to community centers towards becoming fully equipped clinical research sites

    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
    • David Hong, MD
      MD Anderson Cancer Center
    • Krystyna Kowalczyk
    • 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