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U.S. National Institutes of Health
Last Updated: 05/22/12

Compressing Timelines for CTEP-Supported Cancer Treatment Trials — A Response to the OEWG Report

OEWG Timelines and SOPs

Studies Included In / Excluded From the CTEP OEWG Process

The Operational Efficiency Working Group (OEWG) was established to advise the National Cancer Institute (NCI) on strategies to "Identify the institutional barriers that prolong the time from concept approval to accrual of the first patient, and develop solutions for overcoming these barriers." The collaborative effort includes representation from the Cooperative Groups, Phase 1 and 2 U01/N01 programs, Cancer Centers, and other NCI Programs and Divisions. This broad-based, strategically-driven effort, involving all the critical stakeholders in the cancer clinical trials community, resulted in the initiatives and associated implementation plans detailed in this report on "Compressing the Timeline for Cancer Clinical Trial Activation". The following summarizes the OEWG recommendations:

  • Develop a CTEP Action Plan to achieve the agreed OEWG target timeline for each step in clinical trial development

  • Develop collaborative processes involving CTEP, N01/U01 contractors, Cooperative Groups and other trial performance sites for meeting the OEWG target timeline for revision of LOIs, concepts and protocols

  • Develop approaches to reward performance against timelines through a collaborative, empirically based process involving all stakeholders

  • Develop a coordinated approach to standardization of protocol elements and protocol development tools involving NCI, the Cooperative Groups and the Cancer Centers in order to speed development and review of protocols

  • Enhance funding and capabilities for use of biomarkers in clinical trials in order to speed activation of trials designed to incorporate integral and integrated biomarkers

  • Perform a rigorous review of each proposed clinical trial concept in advance of protocol development in order to optimize use of clinical trial resources, speed trial development and improve trial quality

  • Establish timelines for clinical trial development (all times in calendar days)

  • Timelines for studies received prior to April 5th, 2012:

    • Phase 1 and 2 LOIs: Time from LOI receipt (for unsolicited LOIs) or due date of mass solicitation (for mass-solicitation LOIs) to opening trial to enrollment:
      • Target timeline: 210 days
      • Absolute deadline: 540 days
      • Phase 1 and 2 LOIs include:
        • Unsolicited LOIs - phase 1, 1/2, and 2
        • Mass-solicitation LOIs - phase 1, 1/2, and 2, including Cooperative Group mass-solicitation LOIs ≥ 100 patients
        • Cooperative Group phase 1, 1/2, 2 LOIs < 100 patients
    • Cooperative Group Phase 1/2 or 2 Concepts ≥ 100 patients: Time from 21 days prior to Concept’s actual evaluation date by Steering Committee to opening trial to enrollment:
      • Target timeline: 240 days
      • Absolute deadline: 540 days
      • These concepts do not include Cooperative Group phase 1/2 or 2 trials ≥ 100 patients that are in response to a LOI mass solicitation.
    • Phase 3 Concepts: Time from 21 days prior to actual evaluation date by Steering Committee to opening trial to enrollment:
      • Target timeline: 300 days
      • Absolute deadline: 730 days

  • Timelines for studies received after April 5th, 2012:

    • Phase 1 and 2 LOIs: Time from LOI receipt (for unsolicited LOIs) or due date of mass solicitation (for mass-solicitation LOIs) to opening trial to enrollment:
      • Target timeline: 210 days
      • Absolute deadline: 450 days
      • Phase 1 and 2 LOIs include:
        • Unsolicited LOIs - phase 1, 1/2, and 2
        • Mass-solicitation LOIs - phase 1, 1/2, and 2, including Cooperative Group mass-solicitation LOIs ≥ 100 patients
        • Cooperative Group phase 1, 1/2, 2 LOIs < 100 patients
    • Cooperative Group Phase 1/2 or 2 Concepts ≥ 100 patients: Time from Concept’s actual, initial evaluation date by Steering Committee to opening trial to enrollment:
      • Target timeline: 210 days
      • Absolute deadline: 450 days
      • These concepts do not include Cooperative Group phase 1/2 or 2 trials ≥ 100 patients that are in response to a LOI mass solicitation.
    • Phase 3 Concepts: Time Concept’s actual, initial evaluation date by Steering Committee to opening trial to enrollment:
      • Target timeline: 300 days
      • Absolute deadline: 540 days

IMPORTANT

  • The OEWG tracking for Target Timelines begins with all LOIs and Concepts received after 4/1/2010.

  • The absolute deadlines take effect 1/1/2011. All LOIs, concepts and protocols that have not met the deadline on or after this date will be automatically terminated.

STUDIES INCLUDED IN / EXCLUDED FROM THE CTEP OEWG PROCESS

Inclusions:

  • All treatment trials submitted to NCI/CTEP by CTEP/DCTD grantees and contractors, regardless of whether or not CTEP holds the IND.
  • All treatment trials submitted to NCI/CTEP in which CTEP holds the IND or is supplying drug, except for trials led by other NIH institutes.
  • AIDS Malignancy Clinical Trials Consortium (AMC) treatment trials reviewed by CTEP except for select AMC trials developed in countries with areas endemic for HIV infection and high HIV-related cancer burdens that have limited medical resources.
  • NCI intramural trials involving a CTEP IND or CTEP-supplied drug.
  • All Cancer Imaging Program (CIP) studies (treatment-related and non-treatment-related).

Exclusions:

  • Select AMC trials developed in countries with areas endemic for HIV infection and high HIV-related cancer burdens that have limited medical resources.
  • Trials led by other NIH institutes – for example, NHLBI, including BMT-CTN-led trials – are excluded.
    • Note: Trials that would be included in the CTEP OEWG process per the criteria above ("Inclusions") and in which BMT-CTN, for example, is a participant are still included in the OEWG process.
  • Cancer control and prevention studies are excluded.
  • NCI intramural studies not involving a CTEP IND or CTEP-supplied drug are excluded.
  • Clinical Center studies not involving a CTEP IND or CTEP-supplied drug are excluded.
  • Stand-alone correlative studies are excluded (i.e., non-treatment studies, unless CIP; all CIP studies are included in the CTEP OEWG process).

OEWG TIMELINES AND SOPs

CTEP has assisted with the coordination in ‘operationalizing’ the OEWG recommendations. Further details and procedures for operationalizing the OEWG recommendations can be found at the links below: