SWOG External Translational Medicine Proposal and Application Process

This webpage provides information for the proposal and application process for translational medicine proposals requesting utilization of specimens from SWOG-led trials that do not appear in the NCTN Navigator System (most SWOG-led Phase 2, some Phase 2/3, and older Phase 3 studies), with the exception of the Prostate Cancer Prevention Trial (PCPT) and Selenium and Vitamin E Cancer Prevention Trial (SELECT) trials.

To encourage and optimize the use of specimens banked from legacy studies, SWOG invites investigators to apply through the process outlined below. Making these tissues widely available aims to advance research and foster collaboration.

SWOG investigators are encouraged to develop their correlative science proposals in consultation with the relevant research committee, including the Translational Medicine Chair(s), Statistician(s), and Committee Chair(s) to ensure feasibility and alignment with ongoing research.

For more information about biospecimens and their associated data elements from SWOG-led clinical trials, please see: Clinical Trials Search | SWOG.

Purpose  

SWOG Policy 39: Acquisition, Maintenance and Use in Research of Tissue and Other Biologic Patient Specimens is designed to ensure compliance with current NCI guidelines for specimen banking from cooperative groups while making SWOG specimens available to a broader research base. The goal of this process is to obtain a commitment for the use of available materials.

Eligibility  

Both SWOG and external investigators are welcome to submit proposals for consideration.

Note for SWOG investigators: Translational medicine proposals that were not integrated into the original clinical study protocol should be submitted following this process.

Specimen Availability  

To confirm the availability of specimens and associated data elements from a SWOG-led trial (not included in NCTN Navigator):

  • Complete the Following Sections of the SWOG Proposal for an Integral, Integrated, or External (non-Navigator) Translational Medicine Study Using SWOG Specimens Form:
    • Section 3 (questions a–c)
    • Section 5a and 5c
    • Section 12 (if applicable)
    • Provide all known details regarding the requested specimens and data.
  • Submit the Request
    • Email the partially completed form to the Primary Statistician for the applicable research committee (if known) or to biospecimens@swog.org (for routing to the appropriate statistical contact).
    • Email Subject Line: Request for confirmation of specimen and data availability for an External TM proposal from {insert SWOG study number(s)}.

Proposal Submission Process  

Proposal Review Process  

  • The TM proposal must be reviewed and approved by the respective Research Committee for submission for SWOG Executive Committee review.
  • The SWOG Executive Review Committee will review the proposal, and the applicant will receive an outcome letter via email.
  • After full SWOG Executive Review Committee approval is obtained, the Protocol Project Manager for the respective research committee will provide instructions for obtaining NCI approval for use of the specimens for translational medicine objectives external to the primary clinical trial.

Distribution of specimens

The release of samples from SWOG biorepositories will be authorized after the following have occurred:

  • Material and/or Data Use Agreement(s) are executed,
  • Funding is secured and any associated funding contracts are executed,
  • Documentation of IRB approval for the project is provided.

Questions

For questions or clarification: Contact the SWOG Network Operations Center (NOC) in San Antonio via Email: translationalmedicine@swog.org or at 210-614-8808.