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 disease or 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 utilize specimens that were collected in association with SWOG-led studies that do not appear in the NCTN Navigator system (most Phase 2, some Phase 2/3, and older Phase 3 studies), investigators will submit a request for SWOG to confirm specimen (and associated clinical data) availability and a subsequent SWOG External Translational Medicine (TM) proposal for SWOG Executive Committee review and approval. After SWOG Executive Committee approval of the External TM proposal, the Protocol Project Manager for the SWOG disease or research committee that led the primary clinical trial will provide next steps for NCI review and approval of the External TM proposal.

Note: If a translational medicine proposal requests specimens from multiple trials, and any one of those trials is currently included in NCTN Navigator, then the entire request must be submitted via the Navigator portal.

For access to specimens from SWOG-led trials that do not appear in the NCTN Navigator portal, refer to the SWOG External Translational Medicine Proposal or Prostate Cancer Prevention Trial (PCPT) and Selenium and Vitamin E Cancer Prevention Trial (SELECT) links below for more detailed information.

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

Investigators are encouraged to carefully review which clinical trials and data elements may be relevant to their proposal prior to submitting a request for SWOG to confirm biospecimen availability as indicated below.

Important steps prior to submitting a request for SWOG confirmation of biospecimen availability:

• Review the protocol of interest. In particular, review:

  • Protocol Sections 1, 15, and/or 18 to determine if the protocol may already contain integral or integrated TM objectives/endpoints that may overlap with the External TM proposal.
  • Protocol Sections 12, 15 and/or 18 to confirm specimen types collected (and if applicable, methods of collection and processing upon receipt), and corresponding collection timepoints. Many SWOG protocols include serial collection timepoints.
  • For access to SWOG-led protocol documents, refer to the How to Access SWOG-led protocol documents online (at SWOG.org and CTSU.org) instructions.
  • For more information about biospecimens and their associated data elements from SWOG-led clinical trials, please see: Clinical Trials Search | SWOG.
     

• For TM proposals that require associated clinical data elements: Review the “Master Forms Set” for clinical data that was collected in association with the conduct of the primary trial. 

  • Preliminary review and understanding of the basic data elements that were collected will expedite the process of confirmation of requested data elements.
  • For SWOG-led protocols that are accessible online, an Adobe (.pdf) version of the Master Forms Set will be posted online under the same "Download Documents” location on the protocol abstract page SWOG.org, or on the protocol abstract page on CTSU.org under Documents>>Protocol-Related Documents>>Case Report Forms filter (or folder).
     

• Contact the TM Chair for the respective disease or research committee to discuss:

  • The TM proposal idea and specimen availability,
  • Timing – relative to when primary outcomes of the primary trial are anticipated to be published, and
  • Any potential competing approved studies or proposals in process, as to whether proposed TM objectives or proposed specimen utilization may overlap with approved work or work in progress.
  • Investigators can locate the contact information for the disease or research committee TM chair at: Disease / Research Committees | SWOG (login with CTEP credentials required).
    • From the filter list at the top of the webpage, sort by the Translational Medicine Subcommittee, Pathology Subcommittee, or Cytogenetics Subcommittee (e.g., Translational Medicine Subcommittees are displayed as “Trans Med <Disease> Sub” in the filter list) to locate the respective TM Chair for the disease committee.
  • If a TM chair is not identified for the TM Subcommittee (or if there is not a TM Subcommittee listed for the respective disease or research committee), the investigator should instead contact the Chair of the primary disease or research committee.
     

• Contact the respective disease or research committee statistician to:

  • Assess feasibility, and
  • Confirm the availability of the requested type (and volume) of specimens and associated data elements at protocol-specified collection timepoints.
  • Investigators can locate the statistician(s) that for the respective disease or research committee at: Staff | SWOG.

To Request SWOG Confirmation of Biospecimen Availability:

To find out if specimens and any associated data elements are available from a specific SWOG-led trial or trials (not included in NCTN Navigator):

• Complete the SWOG Biospecimen Query Form and submit to biospecimens@swog.org.

For general inquires or interest in availability of specimens from SWOG-led studies that do not appear in the NCTN Navigator portal, contact the Primary Statistician or Translational Medicine Chair (or Committee Chair, in event that the committee does not have a Translational Medicine Chair) for the respective 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.