This week I recorded my presentation of the first module in a course aimed at orienting new SWOG site principal investigators (site PIs) to the role. The sequence will soon be available among our growing library of training materials.

As the success of our trials depends critically on the effectiveness of our site PIs, this seemed a good opportunity to engage readers with some SWOG 101 education, about a complex position with many responsibilities.

Our site PIs represent our member institutions in SWOG’s governance and research endeavors. Importantly, about two-thirds of the voting members of our board of governors are seated as site PIs of governing institutions (the board is rounded out with other SWOG leadership).

The site PI has primary responsibility for their institution’s research program related to SWOG trials, including adhering to the group’s procedures, meeting its standards, keeping it apprised of local membership changes, monitoring quality assurance audits, and communicating all SWOG policies (and policy changes) to the site’s research staff.

Succeeding in the role requires a high-level understanding of the operation of many corners of SWOG’s and the NCI’s systems. Success also demands seamless collaboration with the site’s head clinical research associate (CRA) – a collaboration so critical we will soon give it its own dedicated training module.

Here’s a quick list of the key responsibilities of a site PI:

  • serves as the primary champion for SWOG and SWOG research activities within their institution
  • fosters engagement and mentoring of the site’s investigators within SWOG, particularly by involving them in committees based on their areas of research interest
  • helps SWOG meet projected accrual goals, both by determining which protocols the site champions and opens (based on the site’s strengths, expertise, and patient population) and by ensuring trial accruals are credited to SWOG to meet group membership requirements and our overall enrollment goals
  • ensures the site complies with all SWOG and NCI policies and procedures, including timely submission of data, biospecimens, and imaging
  • monitors the institution’s overall performance and resolves audit deficiencies, if any
  • monitors the performance of affiliate sites as well
  • directs the site’s use of funds received to support SWOG studies
  • confirms procedures are in place for approving new investigators and, with head CRA support, for ensuring they’re credentialed in the NCI’s systems and submitted to the SWOG roster
  • determines which investigator will be listed as a co-author when the site’s trial participation has earned it co-author recognition on a publication
  • for site PIs at governing institutions, serves on SWOG’s board of governors
  • regularly attends SWOG group meetings – at least one every two years (for board of governor site PIs, The Hope Foundation offers travel support to all group meetings)

To help ensure our site PIs succeed, we’re working to provide training content that’s as clear and detailed as possible about our expectations and SWOG and NCI processes. 

When we post our new training sequence to our learning management system (soon!), it will include a module titled “Perspectives of a Site Principal Investigator,” an insider view presented by a seasoned site PI. Their advice is invaluable and represents another form of the mentoring that’s central to the site PI’s job description.

I want to close by thanking all of our SWOG site principal investigators. As I said in recording my training presentation, your agreement to fulfill these key communication, institutional support, and oversight responsibilities makes possible SWOG’s work, and increases our impact in improving the lives of our patients.

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Trial of the Week

S1802: Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

Study S1802 has been open since September of 2018 and is enrolling patients with metastatic adenocarcinoma of the prostate.

These patients receive standard systemic therapy (androgen-deprivation therapy selected from among NCCN guideline-indicated options) and are randomized one-to-one to continue with systemic therapy alone or systemic therapy plus definitive treatment of the primary tumor – either surgery or radiation therapy (choice of physician and patient).

The study asks whether adding definitive treatment of the primary tumor will improve disease control and overall survival in these patients. It also includes quality-of-life objectives comparing patient-reported urinary function, urinary bother, pain, and physical functioning.

With a goal of 1,273 participants, the trial thus far has enrolled 712 patients at 151 sites. The study is open at about 300 sites overall. 

The month accrual target is 21 patients. The average monthly rate has been well below that level, but in May of this year, 16 patients were enrolled, so that monthly target seems within reach with additional sites, awareness, and effort.

MD Anderson Cancer Center and the Metairie Multi-Specialty Clinic within the LSU Healthcare Networkare the leading accruers to the trial (by a respectable margin).

The S1802 study chair is Brian F. Chapin, MD, of MD Anderson Cancer Center.

Learn more on the SWOG S1802 page or the CTSU S1802 page. A CIRB-approved video for patients is also available.

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