Biospecimen Availability and Translational Medicine Proposal Application Process

SWOG Biospecimen Bank

The SWOG Biospecimen Bank is housed at Nationwide Children’s Hospital in Columbus, Ohio, and holds more than 1.3 million specimens contributed with informed consent by more than 70,000 trial participants, including many with multiple timepoints and specimen types.

These specimens are linked to high-quality, well annotated, clinical trial outcomes and other data, including patient-reported outcomes, many from prospective, randomized NCTN trials – which make them a limited and unique resource.

These banked specimens are available for secondary TM studies after the associated primary clinical trial outcomes have been published, via review and approval by one of two mechanisms:

1. LOI (for confirmation of biospecimen availability) and subsequent Application via the NCTN Navigator system for approval by the NCTN Core Correlative Sciences Committee (CCSC), or
2. SWOG confirmation of biospecimen availability and SWOG leadership (followed by NCI) approval of the secondary TM projects. 

Translational Medicine Proposal Pathways

The application and review processes differ depending on whether the SWOG-led trial (and associated collected specimens) appear in the NCTN Navigator System. 

Pathway 1: LOI and Proposal Submission via NCTN Navigator System

The NCTN Navigator System inventory includes specimens from NCTN Phase 3 trials (and other trials, such as some Phase 2/3 studies, that included large biospecimen collection components) with clinical data that:
1)  were activated in 1995 or later and
2)  are completed, with the primary outcome reported.

Currently, NCTN Navigator includes specimens collected during the conduct of more than 20 SWOG-led trials.

• For requests to utilize specimens cataloged in the Navigator portal (Navigator-Login), investigators will submit a Letter of Intent (LOI) and subsequent application via NCTN Navigator for review and approval by the NCTN Core Correlative Sciences Committee (CCSC).
• While SWOG review is not required prior to submission of a LOI or application via the NCTN Navigator System, it is generally recommended that SWOG investigators notify and work with the applicable research committee and statistician assigned to that committee prior to submission of a LOI and subsequent application via NCTN Navigator.  The respective SWOG Committee will often provide valuable clinical, scientific, and statistical input that strengthens the proposal.

Pathway 2: Proposal Submission via SWOG Executive Committee Review Process Followed by NCI Review

For requests to use specimens from SWOG-led studies that are not listed in the NCTN Navigator system (including most Phase 2, some Phase 2/3, and older Phase 3 studies), investigators must:

1. Submit a request for SWOG to confirm specimen and associated clinical data availability.
2. Submit a SWOG External Translational Medicine (TM) proposal for review and approval by the SWOG Executive Committee.
3. After SWOG Executive Committee approval, the Protocol Project Manager (PPM) for the SWOG Research committee overseeing the original clinical trial will guide the investigator on the next steps for NCI review and approval of the proposal.

Important:

• If a proposal includes specimens from multiple trials and any of those trials are listed in NCTN Navigator, the entire request must be submitted through the Navigator portal.
• For more details on accessing specimens from SWOG-led trials that are not in NCTN Navigator, refer to the SWOG External Translational Medicine Proposal, Prostate Cancer Prevention Trial (PCPT), or Selenium and Vitamin E Cancer Prevention Trial (SELECT) links below.

Prior to Submitting a Request to SWOG to confirm Biospecimen Availability:

1.   Review the SWOG-led Protocol of Interest

• Check the protocol details to determine if your proposal aligns with existing study objectives and specimen availability:
  • Key SWOG protocol sections to review:
    • Sections 1, 15, and/or 18: Identify existing translational medicine (TM) objectives or endpoints that may overlap with your proposal.
    • Sections 12, 15, and/or 18: Confirm specimen types collected, collection methods, processing procedures, and collection timepoints (many SWOG protocols include serial collections).
  • How to Access SWOG-led protocol documents:
    • Refer to the How to Access SWOG-led protocol documents online (at SWOG.org and CTSU.org) handout.
    • For information about SWOG-led trials, refer to: Clinical Trials Search | SWOG.

2.   If the TM proposal requires associated clinical data:

• Check the study-specific Master Forms Set for data elements collected during the primary trial.
• A preliminary review of available data elements will help expedite the confirmation process.
• Where to find the Master Forms Set:
  • If the SWOG-led protocol is available online, a PDF version of the Master Forms Set can be found at one of the following locations (login with ID.me credentials):
    • On  SWOG.org, under the study-specific protocol abstract page "Download Documents" section (posted under a separate “Master Forms Set” link or as an appendix to the Protocol document).
    • On CTSU.org, under study-specific protocol abstract page Documents tab >> Protocol-Related Documents tab >> Case Report Forms filter.

3.   Contact the TM Chair for the Relevant Research Committee

• Before submitting your request, discuss the following with the Translational Medicine (TM) Chair:
  • Proposal idea & specimen availability
  • Timing – Ensure your request aligns with the expected publication of primary trial outcomes.
  • Potential conflicts – Identify any competing approved studies or proposals that may overlap with your request.
• To find TM Chair contact details:
  • Visit Disease / Research Committees | SWOG (login with ID.me credentials required).
  • Use the filter list to locate Translational Medicine, Pathology, or Cytogenetics Subcommittees.
  • If no TM Chair is listed or if there is not a TM subcommittee for the respective Research Committee, contact the primary Research Committee Chair instead.

4.   Contact the Research Committee Statistician

• Reach out to the committee statistician to:
  • Assess feasibility of your request.
  • Confirm the availability of requested specimens and associated data at the protocol-specified collection timepoints.
  • To find statistician contact details, visit Staff | SWOG.

Requesting SWOG Confirmation of Biospecimen Availability:

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

1. 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.
2. Submit the Request
   • Email the partially completed form to the Primary Statistician for the applicable research committee (if known),or send it 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)}.

For General Inquiries

For questions about accessing specimens from SWOG-led studies not listed in the NCTN Navigator portal, contact:

• Primary Statistician
• Translational Medicine Chair
• If no Translational Medicine Chair is available, contact the Committee Chair for the relevant SWOG research committee.

After Approval of a Translational Medicine Proposal

Subsequent proposal approval (regardless of review pathway): Funding (including funding to cover the cost of shipment from the SWOG Biospecimen Bank to the testing location) must be secured (and any associated funding contracts executed), IRB approval must be obtained, and associated data use and material use agreement(s) must be executed.

After all required documentation is in place, the SWOG (or relevant NCTN) Biospecimen Bank will be notified, and specimens can be shipped.

Biospecimen Bank Shipment of Samples

Nationwide Children’s Hospital will provide an estimated cost of specimen retrieval and shipment from the SWOG Biospecimen Bank to the testing location for proposal considerations. To request estimated cost of specimen retrieval and shipment, Email: BPCgrants@nationwidechildrens.org.

Retrieval and shipment times vary based upon the current workload and volume of specimens to be retrieved.  When all required approvals, contracts, and documentation are in place, the SWOG Biospecimen (and/or any other involved NCTN Biobanks) will provide an estimated time-to-shipment of specimens. After all required documentation is obtained, to contact the SWOG Biospecimen Bank regarding timing and logistics of specimen retrieval and shipment, Email: BPCdist@nationwidechildrens.org. 

How to Submit a Translational Medicine Proposal for Review and Approval:

Proposal submission instructions and resources are provided for each review pathway via the links below.

• NCTN Navigator Application
   
• SWOG External Translational Medicine Proposal and Application Process (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)
   
• PCPT and SELECT External Translational Medicine Proposal and Application Process (PCPT and SELECT were two large prostate cancer prevention trials conducted by SWOG, from which there is a large biorepository of participant samples from men who developed prostate as well as lung, colon, and other cancers.)   

Other Biospecimen Resources:

Applicants whose request for biospecimens is found not to be within the scope of SWOG clinical research may wish to consult the NCTN Biobanks Additional Resources page for further information on research involving biospecimens.