SWOG Data Requests and TM Proposals: A How-To Primer: Part 1

We work hard to make these resources available to investigators who will use them in high-value research that will ultimately advance patient care. As such, we are continuously refining our procedures for providing relatively easy and efficient access.

Our data request and our translational medicine proposal (and biospecimen request) processes are distinct procedures, but looked at side by side, they feature many parallel steps. 

In either case, as an investigator with a project in mind, you’ll need to …

• identify the trial (or trials) that may have generated the resources you’re interested in
• determine whether those resources are managed through central NCI systems (if they are, you’ll use those NCI systems instead of much of what follows)
• reach out to the statistician and other leadership on the relevant research committee
• develop a detailed proposal (with input from the statistician and others) to submit for SWOG executive committee review (aka triage)
• potentially revise and resubmit your proposal based on triage feedback
• probably (for TM proposals, definitely) identify a source of funding to cover costs
• work with our contracting & legal team on a resource use agreement
• work with the statistician to actually get those resources delivered
• work with our publications office when it’s time to report results

That’s the big picture. Because there’s a good bit of ground to cover in zooming in on each procedure, below I give details of the data request process only.

Come back next week when I’ll step out the TM proposal process. 

The process described here applies to requests for datasets that will be analyzed externally, outside of SWOG. “Data” here include images, such as radiology scans or scans of slides.

If you’re an investigator wanting access to such a dataset, a first step is to identify the trial (or trials) that may have generated the data you’re interested in. Our clinical trials search tool is a great place to start. Check out this handout or the latter part of the training videos linked below for details on how to operate this search tool to unearth the information you need. 

When researching a trial, also look for publications information to determine whether its primary endpoints have been presented or published. If they have not, no trial data will be released. And if its secondary endpoints have not yet been published, ensure your proposed analysis isn’t covering the same ground. 

With desired data identified, determine whether they’re accessible through the NCTN/NCORP Data Archive website. If they are, you’ll submit your data request there, following their procedures. If they are not, a SWOG data request is probably the route for you. 

Reach out to the primary statistician for the relevant research committee to discuss the details of your request (find them in the SWOG staff listings). If that statistician determines the data are available, and if they have confidence in the value and feasibility of your project, it’s time to complete the SWOG Data Sharing Request template, with input from the study chair(s) and relevant research committee leadership. 

When your data request is ready for executive committee (EC) review, send it to the protocol project manager (PPM) for the relevant research committee (you can find the right PPM in the staff listings). The PPM will confirm you have all required committee approvals in place and will submit your request to the EC (which may ask for a revision and resubmission).

Once you have EC approval in hand, work with our contracting & legal team to execute a data use agreement between SWOG and your institution. You can then work with the statistician to get the requested dataset or to have it sent to the appropriate analyst.

In all steps of this data sharing request process, the speed with which things happen and the setting of priorities will depend on what SWOG resources are available at the time (we generally work with lean margins). 

This is, of course, a high-level view of the process. Dig into the details via these resources:

• Data Requests page on swog.org
• data request flowchart (very helpful visual aid)
• SWOG Policy 43 (governs how we approach requests for sharing of patient data)
• training video on data and TM requests:
  • member version (login required)
  • non-member version

Finally, before you publish or present the results of your work, forward your abstract or manuscript to the SWOG publications office at pubs@swog.org to ensure it complies with SWOG (and NCI and NIH) policies.

Translational research and secondary analyses that build on the resources of our data library and biobank make critical contributions to our work to improve the lives of those affected by cancer. See you next week for Part 2!