SWOG Data Requests and TM Proposals: A How-To Primer (Part 2: TM Proposals)

In last week’s Front Line, I detailed the steps in completing and submitting a request for data. This week, in Part 2, I follow up by detailing how an investigator can submit a translational medicine proposal (and/or biospecimen request) to SWOG. 

From the 30,000-foot level, the process parallels the data request process:

• identify the trials that generated the resources of interest
• find out whether those resources are managed through central NCI systems
• contact the relevant committee’s statistician and other leaders
• craft a proposal (with committee input) to submit for SWOG “triage” review
• submit for NCI core correlative sciences committee review (not part of data requests)
• revise and resubmit (if requested)
• identify funding to cover costs
• work with contracting & legal on a resource use agreement
• work with the primary statistician to get your resources delivered
• work with our publications office when reporting results

Now for the TM proposal details!

Note that this is an overview of the process for external TM proposals – projects drawing from trials that have already had their results presented or published and reported in ClinicalTrials.gov. Those are the trials for which banked biospecimens are available to investigators outside of the study team or lead NCTN group.

For integral or real-time integrated TM proposals in a developing or ongoing trial, additional considerations come into play and the study chairs should work closely with the appropriate protocol project manager (PPM) to move a proposal forward. 

As with a data request, an early step is identifying which clinical trials you’re interested in. In Part 1, I provided some useful details on how to use our clinical trials search tool.

A next step is to determine whether the trial and specimens you want are available via the NCI’s system  – in this case the NCTN Navigator system. If any of the specimens on your list are in Navigator, your entire request must be submitted through that system.

I’ve written about the NCTN Navigator system before, so here I’ll stick to discussing TM proposals that are submitted through SWOG.

The primary statistician and the TM chair for the relevant research committee will be key resources and allies for you throughout this process. Reach out to both to discuss your proposal, how it fits with ongoing research efforts, the feasibility of your request, and whether the specimens and data are likely available.

When you’ve identified the specific data and specimens you want from a SWOG-led trial, you’ll need to submit a formal request to confirm they’re available. This means completing several sections of the official TM proposal form and emailing it to the primary statistician. For key details on making this request, click here and scroll down to “Specimen Availability.”

Once you’ve confirmed the specimens are available, you’ll complete the rest of the TM proposal form, working in close consultation with the statistician and other leaders of the relevant research committee, who must sign off on your request before it goes to triage.

Before triage submission, you’ll also need to:

• Confirm you have a funding source (or in-kind support) to cover costs – for specimen prep and shipping, work performed by SWOG’s Statistics and Data Management Center, and any assays that will need to be run.
• Consult with our contracting & legal team to learn what contractual obligations are tied to the desired specimens and to determine how you’ll meet those obligations.

When all is ready, send your proposal to the research committee’s PPM (check the staff listings, if needed), who will submit it to the executive committee (EC) for review. Generally, you can expect a decision letter within a week of your triage presentation. If the EC requests changes, you'll again work with the relevant research committee and statistician to revise and resubmit.

Once you have EC approval, you’ll move on to the next review cycle – review by the NCI’s correlative core sciences committee (CCSC).

With CCSC approval in hand, you’ll again work with contracting & legal, this time to execute a material and/or data use agreement (MUA or MDUA) between SWOG and your institution. 

You’ll also need to get your project approved by your local institutional review board (IRB). SWOG’s biobank at Nationwide Children’s Hospital will need this IRB approval, confirmation of funding for the project, and your executed MDUA before they can release specimens.

The committee’s statistician will work with you to draw up the specimen pull list, and the biobank will ship those specimens to your designated lab, after which your research fun will finally begin.

As you’ve no doubt gathered, the TM proposal process has many moving parts, and I apologize for writing a dense column. But this work can be key to so much successful oncology research. For details, turn to these resources:

• TM (non-Navigator) proposal flowchart (invaluable in keeping all the steps straight)
• Biospecimen Availability and TM Proposal Application Process (the big picture) 
• SWOG External TM Proposal and Application Process (a narrower focus on the process above)
• SWOG Policy 39 (how we acquire, maintain, and use specimens donated by patients)
• training video on data and TM requests:
  • member version (login required)
  • non-member version

 And remember, data request or TM proposal, before you publish or present, send your abstract or manuscript to pubs@swog.org to ensure compliance. Send meeting abstracts at least two weeks before the meeting’s submission deadline (our publications office has a staff of one).