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Trial Development Timelines (OEWG)

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With the rapid pace of cancer research, clinical trials need to move efficiently from concept to enrollment.  This ensures that that patients benefit from the latest medical research.

CTEP's trial development timelines ensure that promising new therapies can reach patients without undue delays. Investigators may track their study’s progress online, and CTEP staff work with investigators and collaborators during development to overcome obstacles to protocol approval and activation.

About the OEWG and CTEP Trial Development Deadlines

Operational Efficiency Working Group (OEWG)

In 2008, The NCI's Clinical Trials and Translational Research Advisory Committee (CTAC) established the Operational Efficiency Working Group (OEWG) to identify strategies to reduce the time required for clinical trial development and activation.

Read the Operational Efficiency Working Group (OEWG) Report

Based on the OEWG report presented to CTAC in 2009, CTEP developed an action plan, including implementing development timelines and absolute deadlines for trial activation.

CTEP Trial Development Deadlines, Policies, and Definitions

Trial Development Deadlines

The initial trial development timelines went into effect for applicable Letters of Intent (LOIs) and concepts received starting April 1, 2010. Based on an initial review, the absolute deadlines were shortened in April 2012. The deadline for early phase LOIs was further shortened in 2019.  All deadlines are in calendar days. 

Trial Development Deadlines
Trial TypeDeadline 
2010-2012		Deadline 
2012 - Aug 2019		Current Deadline 
Sept 2019 - Present
Phase 1 and 2 LOIs540 days450 days400 days
Phase 1/2 and 2 Concepts540 days450 days450 days
Phase 3 Concepts730 days540 days540 days
Trial Development Timeline Start Date

The CTEP Trial Development Start Date is determined based on the document type and the required review process for the document.  This start date is used to calculate the absolute deadline for all applicable studies. 

  • For all LOIs, the OEWG Start Date is the date of initial CTEP Protocol Review Committee review.
  • For all Concepts reviewed by a Steering Committee, the OEWG Start Date will be the date of the initial, actual Steering Committee review, regardless of the actual submission date. (Please note that the secure Timeline Reports website will use the planned Steering Committee date as the OEWG Start Date until the actual Steering Committee date is entered.)
  • For all Concepts that do not yet have a Steering Committee, the OEWG Start Date will be the date of the initial, actual Concept Review Meeting (for phase 3 Concepts) or the initial, actual Protocol Review Committee review (for NCTN phase 2 Concepts).
CTEP Policy and Procedure for Deadlines

Policy: Studies that are not activated on the CTSU by their CTEP Trial Development Deadline are automatically terminated. The study status will be changed to "OEWG Terminated."

Procedure: CTEP and the lead organization will work collaboratively throughout the protocol development process to achieve the trial development deadline.

  • CTEP will send reminders to the lead organization prior to the deadline.
  • The day after the deadline has been reached:
    • The trial will be terminated
    • A letter will be sent from PIO to the lead organization informing them that the trial has been terminated due to exceeding the deadline.
  • If the site can demonstrate that the trial activated before the deadline was reached, CTEP will change the protocol status from “OEWG Terminated” to “Active.”
Trial Reports Web Utility

Investigators and LPOs should regularly track the progress of their study development milestones using CTEP's Trial Reports Web Utility.

The Quick Reference Guide linked on that page describes how to access and use those tools.

Do The Trial Development Timelines Apply to Your Study?

Not all CTEP-reviewed studies are subject to an OEWG absolute deadline. If you are unsure whether your planned CTEP-reviewed study will be included in OEWG processes, please reach out to the CTEP Protocol Information Office. 

A flow chart or decision tree representing the inclusion and exclusion criteria for studies subject to OEWG timelines.
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Studies with a Trial Development Deadline (Included in OEWG Process) include the following:

  • 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.
  • NCI intramural trials involving a CTEP IND or CTEP-supplied drug.
  • All Cancer Imaging Program (CIP) studies (treatment-related and non-treatment-related).

Studies with no Trial Development Deadline (Exempt from OEWG Process) include the following:

  • Cancer control and prevention studies.
  • NCI intramural studies not involving a CTEP IND or CTEP-supplied drug.
  • Clinical Center studies not involving a CTEP IND or CTEP-supplied drug.
  • Stand-alone correlative studies (i.e., non-treatment studies), except CIP studies.
  • Trials led by other NIH institutes — for example, NHLBI, including BMT-CTN-led trials. 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.

Trial Development Milestones and Timeline Details

CTEP's trial development timelines have three phases. More complex trials (for example, large phase 3 studies) have slightly longer development timelines. All applicable trials must open to enrollment on or before the deadline; those that do not meet the deadline are automatically terminated.

LOI/Concept authoring: initial review to LOI or concept approval.

  1. The LOI is reviewed by CTEP's Protocol Review Committee; Concepts are reviewed by the relevant Steering Committee.
  2. CTEP holds a call with investigators to discuss the consensus review; investigators may be asked to submit a revised LOI or concept.
  3. Approval from both CTEP and the pharmaceutical collaborator are required.
  4. LOIs may also require biomarker plan approval.
  5. The target for this phase is 60 days for early phase trials and 90 days for phase 3 trials.

Protocol authoring: LOI approval to initial protocol submission.

  1. Following approval of the LOI or Concept, the investigators will write and submit the complete study protocol. ETCTN trials will typically work with the Central Protocol Writing Service (CPWS).
  2. The target for this phase is 60 days for early phase trials and 90 days for phase 3 trials.

Protocol approval and opening to enrollment: protocol submission to initial trial activation.

  1. Following initial protocol submission and review, CTEP will hold another consensus review call with investigators. There will likely be one or more rounds of revision and re-review.
  2. Following CTEP approval and collaborator approval, the protocol and associated documents will be routed to the NCI Central IRB and to the FDA for review.
  3. All contract negotiations, study site finalization, CTSU set-up, and trial activation activities are completed.
  4. The trial must open to patient enrollment on or before the Trial Development Deadline (OEWG Deadline).
A visual representation of the CTEP trial development timelines for early- and late-phase clinical trials.
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  • Updated:

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