Supporting Accrual: What’s Standard, What’s Possible, What’s Extra

From our toolbox of accrual enhancement actions and materials, there are some tools we use for every trial, a slew of others we choose among based on the trial at hand, and a smaller set of high-value – and higher-cost – steps we deploy as circumstances require and resources allow. 

For starters, for every new clinical trial, SWOG creates two resources to help raise awareness among prospective trial participants and health care providers:

• We create a patient-friendly trial summary, written in plain language, you can use when introducing the trial to a patient. You can find any trial’s summary at a standardized web address – for example, swog.org/S2104.
  • This URL is your quickest, login-free route to a printable PDF when you need to present a trial to a patient.
  • Or you can download a PDF from the trial’s CTSU.org page (usually labeled “Patient-Friendly Summary” under “CIRB Approved Documents”).
  • We also post a Spanish-language version of the summary several months after activation, also linked from the swog.org/S2104-type web address.
• We develop a social media toolkit with patient-directed and provider-directed posts and graphics. SWOG posts these resources to its social media accounts to help raise awareness of our trials and makes them available to study teams. Patient-directed posts include a link to drive viewers to the patient-friendly trial summary for more information. Toolkits can be downloaded from a trial's SWOG.org or CTSU.org page.

In addition to the above, we may develop other study recruitment plans and materials based on a comprehensive review of study factors, including 

• the trial’s specific aims
• the target population
• particularly ambitious accrual and diversity goals
• the trial’s design and complexity
• regulatory considerations

This tailored approach, managed by our recruitment and retention specialist Jamie Sundstrom, in coordination with our recruitment and retention committee and others, ensures that recruitment activities and materials are aligned with the unique needs of each study and fall within the scope of available group resources.

These materials and activities may include the following, when deemed appropriate:  

• flyers for patients or staff
• targeted patient education brochures
• Frequently Asked Questions (for patients or for staff)
• fact sheets for staff
• monthly accrual tracking emails to active sites
• ad hoc trial webinars

Other recruitment efforts and materials, when identified as appropriate, often require additional budget resources, which may come from an industry partner on the trial or via an application to Hope’s Trial Education Fund. Here are some examples:

• a trial kickoff session, possibly at a group meeting (kickoffs may also be done virtually – usually at less expense)
• a patient education video (these are reserved for complex trials with specific educational needs)
• additional web-based patient resources, beyond our patient-friendly summary

For particularly complex trials, such as master protocols, we may regularly publish a trial-focused newsletter to help keep investigators and site staff informed about trial developments, planned changes, best practices, … and who’s up top on the list of top-accruing sites. 

At activation of a few high-priority trials – such as Pragmatica-Lung, myeloMATCH, or our Lung-MAP 3.0 relaunch – SWOG undertakes wider publicity campaigns to reach the oncology research community and the general public. These campaigns have seen us partner with other NCTN groups, the NCI’s media branch, and advocacy organizations to issue press releases, publish editorials in oncology trade journals, and host virtual press briefings.

Extraordinary efforts such as these can help ensure extraordinary results; the recently closed Pragmatica-Lung is a prime example. To help determine whether or not they are necessary and “worth it”, we start with the basics, analyze each trial’s needs, and take added steps that balance those needs against available resources. 

And don’t underestimate the impact of those “basics” we start with. In 2024, our patient-friendly summaries on swog.org were visited more than 5,000 times (not even counting access to these resources via CTSU.org).  

Of course, beyond the trial-specific resources I’ve discussed above, SWOG provides more general resources and expertise that can be applied across trials. Our recruitment and retention committee, for example, has hosted a series of symposia at recent group meetings on evidence-based strategies for enrolling participants from a range of historically underrepresented populations.  

And our genitourinary committee sponsored an “Art of Patient Enrollment” symposium last fall that, although it was labeled as specific to GU trials, imparted valuable recruitment lessons that extend across disease sites. I highly recommend visiting the recordings of all of these events, which are available to logged-in SWOG members.

If you have questions about these and other trial recruitment resources, I encourage you to reach out to recruitment@swog.org. The toolbox awaits. 

___________________________________________________

Trial of the Week

S1900J: A Phase II Study of Amivantamab SC (subcutaneous) in Participants with MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study) 

SWOG S1900J, activated in October, is the newest Lung-MAP biomarker sub-study. It’s enrolling patients with MET amplification in stage IV or recurrent non-small cell lung cancer (NSCLC).

All patients are treated with subcutaneous amivantamab, a bispecific antibody targeting both EGFR and MET. Subcutaneous administration should be quicker than intravenous, a plus for both patients and treatment sites.

Because MET amplification is a particularly complicated biomarker, only a subset of the Lung-MAP-approved NGS assays will be accepted for assigning patients to S1900J. Consult the Lung-MAP Sub-Studies Reference Table linked from swog.org/lung-map-resources for the current list of allowable assays for this sub-study.

Drs. Christian Rolfo and Shirish Gadgeel are S1900J study chairs, and the trial’s enrollment goal is 88 participants. The study is now open at more than 80 sites, with roughly 300 more in the process of opening it. Is yours on the list?

Learn more via the SWOG S1900J page or the CTSU S1900J page. A patient-friendly summary is also available, at swog.org/S1900J, which you can use when presenting the trial to a patient (soon to be available in Spanish as well).