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On the Road to Transforming Cancer Clinical Trials—Update May 2013


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On the Road to Transforming Cancer Clinical Trials—Update May 2013

NCI is transforming its national program for conducting cancer clinical trials to create a highly integrated network that can address rapid advances in cancer biology. The new system, called the NCI National Clinical Trials Network (NCTN), is tentatively slated to be up and running starting March 2014.

This is a periodic update on the transformation process that will appear in this space.

N
NCTN Timeline

Summer 2013—Scientific Merit Review

Fall 2013—National Cancer Advisory Board Review

(Tentative) March 1, 2014—Anticipated Start Date for NCTN


EXT STEPS

The next action in launching the NCTN is the scientific review process. Applications for the key components of the new network program will be reviewed in summer 2013 based on their scientific merit by experts in clinical trials followed by NCI Advisory Council review in fall 2013. Based on this schedule, the anticipated start date for the NCTN is March 1, 2014.



HOW THE NEW NETWORK COMPONENTS WILL WORK

NCTN will be a new integrated clinical trials network with greater capabilities and appropriate incentives to promote a better overall coordination and collaboration among the various stakeholders in the development and conduct of clinical oncology treatment and advanced imaging trials. The new network will use an inclusive process for generating and evaluating clinical trial concepts, involving broad representation from the oncology community including academic and community clinical investigators and their research teams, translational science investigators, statisticians, and patient advocates, primarily for late phase, definitive, clinical trials to evaluate innovative cancer treatments in specific cancers and/or with a focus on specific modalities, such as imaging, radiation, and surgery.

NCTN will include six key components with applicants competing for grants under the program every five years. The six key components of the NCTN include:


  • Network Group Operations Centers for up to four adult groups and one pediatric group

These centers will provide scientific leadership for developing and implementing multi-disciplinary, multi-institutional trials in a range of diseases and special populations as well as be responsible for timely protocol development and management. These awards are structured to emphasize that scientific achievements may likely be best achieved by the entire network working vigorously in an integrative and collaborative manner


  • Network Group Statistics and Data Management Centers associated with each of the Network Group Operations Centers

Working in tandem with the Operations Center grantees, these centers will be responsible for providing the statistical expertise required to ensure effective scientific design and conduct of clinical trials

  • Canadian Collaborating Clinical Trial Network for up to one Canadian group that will serve as a collaborating partner with the US Network Groups

  • Network Lead Academic Participating Sites (LAPS) for an estimated 30 to 40 awards

This new award category, targeted to NCI Comprehensive and Clinical Cancer Centers as well as other academic centers, are designed to help revitalize the role of these institutions in NCI clinical trial participation and ensure continued strong community medical center participation in NCTN cancer clinical trials. LAPS will provide scientific leadership in development and conduct of clinical trials in association with one or more adult network groups. Also, as an incentive to receive an increased per-case reimbursement for the data management associated with patient enrollment, LAPS must maintain a “high performance” standing in accrual to NCTN clinical trials


  • Network Radiotherapy/Imaging Core Services Center for up to one award to provide core services across the NCTN program

For research involving radiation therapy or imaging, this center will provide scientific leadership across the network for incorporating quality assurance and image data management, including integrated IT platforms, into the conduct of NCTN clinical trials

  • Network Group Integrated Translational Science Centers for an estimated 5 to 7 awards to promote integration of translational science into NCTN clinical trials

These grants will provide support for investigator leadership and expertise to facilitate incorporating translational science into clinical trials and help aid hand-offs of early phase clinical trials and translational science discoveries into NCTN late phase, definitive clinical trials

BACKGROUND

For more than 50 years, the NCI has supported a standing clinical trials infrastructure – the NCI Clinical Trials Cooperative Group Program – to conduct large-scale, clinical treatment trials across the nation. There have been several recent evaluations* of this Program, including evaluation by an independent body of experts convened by the Institute of Medicine (IOM). In 2010, the IOM issued a report called A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.

In their evaluation of the Program, the IOM recommended that NCI implement the following four consensus goals in transforming the clinical trials system:


  • Incorporate innovative science and trial design into clinical trials

  • Improve prioritization, support, and completion of trials

  • Improve speed and efficiency of trial development and activation

  • Incentivize participation of patients and physicians

In addition, the IOM recommended maintaining one pediatric group while consolidating the nine existing adult cooperative groups to function in a more collaborative and closely integrated approach and use 21st century technologies to perform the phase 2 and 3 trials necessary to bring new cancer treatments to patients in a more expeditious manner.

NCI incorporated these four consensus goals into its transformation of the clinical trials system with the release of six Funding Opportunity Announcements (FOAs) and Program Guidelines for the new NCTN in July 2012 with receipt of applications for the new program due in January 2013.

* Two other groups that evaluated aspects of the Program recently and made recommendations for re-invigorating it were the NCI Clinical Trials Working Group, which issued a report in 2005, and the NCI Operational Efficiency Working Group, which released its findings in 2010. The suggestions made by these Working Groups were also considered by the IOM.

FOR FURTHER INFORMATION

This list includes some recent presentations by NCI leadership that provide an update on NCI accomplishments and progress related to transforming its entire clinical trials system, as well as historical background information.



Implementing a National Cancer Clinical Trials System for the 21st Century: IOM Workshop #2—this Feb. 13, 2013, workshop includes presentations by:

  • Dr. James Doroshow, NCI Deputy Director for Clinical and Translational Research

  • Dr. Jeffrey Abrams, Associate Director, Cancer Therapy Evaluation Program (CTEP) and Acting Director for Clinical Research in the NCI Division of Cancer Treatment and Diagnosis (DCTD)

  • Dr. Robert Diasio and Dr. George Sledge, Co-chairs, NCTN Working Group, which is part of the Clinical Trial Strategic Planning Ad hoc Subcommittee of the NCI Clinical Trials and Translational Research Advisory Committee

  • Dr. Worta McCaskill-Stevens, Chief, Community Oncology and Prevention Trials Research Group, NCI Division of Cancer Prevention, who talked about the NCI Community Oncology Research Program (NCORP) being formed concomitantly with NCTN

Impact of the Implementation of the Operational Efficiency Working Group (OEWG) Report on the Clinical Trials System—this presentation by Dr. Jeffrey Abrams was to the National Cancer Advisory Board on Feb. 8, 2013. This talk includes an update of target deadlines for activating new clinical trials.

Several Presentations related to clinical trials, including one on the evaluation of the Specialized Programs of Research Excellence (SPOREs), were given to the Clinical Trials and Translational Research Advisory Committee on Nov. 30, 2012.



Cancer Center Support Grant Guidelines and Associated Information—first issued Sept. 2012. Provide new application information as well as updated policies and guidelines related to grants submitted after Jan. 25, 2013.

In April 2012, the DCTD Director wrote a brief overview message describing the entire Division’s drug discovery and development programs. It can be found on the DCTD website.



Redesign of the Early Experimental Therapeutics Program: NCI Early Phase Therapeutics Network—a March 2012 presentation by CTEP’s Dr. Percy Ivy to the Clinical Trials and Translational Research Advisory Committee about plans for changes to early clinical trials, which precede larger trials to be conducted by NCTN.

Transforming the NCI Clinical Trials Enterprise—an NCI website, overseen by the Coordinating Center for Clinical Trials, providing historical background, reports, resulting initiatives, and progress leading up to the FOAs for the NCTN as well as other information.

Coordinating Center for Clinical Trials—the NCI organization that coordinates some of the evaluation committees involved in the NCI clinical trials system and plays a key role in already constituted initiatives related to transformation activities.



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