One Form to "Rule" Them All (and in the TM Bind Them)

Our translational research generally builds on resources from our clinical trials, just as our clinical studies build on information learned from our translational research. We’re always trying to make it easier for our investigators to propose and engage in translational research projects that use those SWOG trial resources.

To this end, our teams at the Network Operations Center and the Statistics and Data Management Center have been working to streamline the proposal process for investigators and – we hope! – to reduce confusion. As one step in that process, we’ve just released an updated translational medicine (TM) proposal form (download as a Word document).

The new proposal form aligns seamlessly with current NCI and SWOG standards. It should help enhance our study teams’ understanding of the TM proposal process; it smooths internal workflows by ensuring all relevant information (including on data use) is captured in one place; and it paves the way for greater efficiency and collaboration.

Our updated form streamlines SWOG’s review process by aligning it with the questions and format expected by the NCI. This should ease the process of incorporating the information we collect into the official NCI TM proposal forms. These include the existing “Proposal for Use of NCTN Clinical Trial Biospecimens” form – for TM projects with studies that have already published their primary results – and the new NCI form now being tested for TM proposals that use resources from ongoing trials (i.e., studies not yet published).

On the SWOG side, the form improves internal processes by consolidating what previously were separate forms for integral, integrated, and external TM proposals – one form will now truly rule them all (if you don’t get the truly witty reference, you might just be too young). This integration is evident in the new form’s title: “SWOG Proposal for an Integral, Integrated or External (non-Navigator) Translational Medicine Study Using SWOG Specimens.”

This form also incorporates questions previously asked on the outdated SWOG Biospecimen Query Form, which was used to determine availability of banked biospecimens. We’re phasing out that query form as a separate document; all is now integrated. You can learn more about this – and about the external TM proposal process overall – on the Biospecimen Access page.

Our goal in recasting the TM proposal form was not only to improve efficiency and make the process easier for investigators and study teams.  We also think the update can improve our proposal success rate with the NCI.

Recent NCI disapprovals of SWOG TM projects have highlighted the absence of specific details about assays and additional statistical information. By incorporating these expected elements into our proposal form, we can ensure they’re captured early, increasing the likelihood of success during NCI review.

Revamping the form is only one step in our ongoing work to revise and streamline SWOG’s entire TM proposal process – and our data request process – but that’s a topic for another Front Line (or two).

For now, I want to acknowledge that the development of this new streamlined, consolidated TM proposal form represents a significant achievement by our Network Operations Center and Statistics and Data Management Center.

Thank you to all who have worked hard on this, with a particular shoutout to our protocol department’s Crystal Miwa, Laura Gildner, Chris Kippola, and Megan Keim, not only for leading this update effort but also for their wonderfully lucid summary of the changes made and the rationale for them. I’ve cribbed liberally from their “key takeaways” document in composing this Front Line. So, in this case they’ve streamlined even my composition process! 

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Trial of the Week

S1925: Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

S1925 has made a previous “Trial of the Week” appearance, but it’s been some time, and the protocol has since been revised, so the trial definitely warrants a repeat appearance in this space.

S1925 is enrolling patients with high-risk chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL) who have been diagnosed within the previous 18 months but are not yet experiencing symptoms of the disease.

This post-diagnosis window was previously limited to 12 months – the protocol eligibility extension should increase the pool of patients who might be candidates for the trial and should give sites more time to identify prospects.

The study asks whether starting these patients on treatment with targeted therapy immediately versus waiting until the onset of symptoms (active surveillance is a standard approach) can extend overall survival. 

It also looks at whether early treatment improves patients’ health-related quality of life. Although early treatment may ease the anxiety that can come with waiting, it can also bring treatment-related toxicity.

S1925 was activated at the end of 2020 and has accrued 128 patients at 52 sites, with a goal of enrolling 247 patients.

Deborah Stephens, DO, is S1925 study chair, and the trial is now open at more than 600 sites. 

The University of Utah’s Huntsman Cancer Institute remains the accrual leader on the trial. The University of Rochester, however, is not far behind, with Ohio State University Comprehensive Cancer Center a close third.

Learn more about the study from the SWOG S1925 page or the CTSU S1925 page. A patient-friendly summary of S1925 is also available to use as an aid in presenting the study to patients (also available in Spanish).