The Evolution of Protocol Development at SWOG

SWOG actually put protocol development improvement on the SWOG agenda in 2012, during a leadership retreat. We re-visited this when we met to write our 2019 strategic plan, as well. The reasons are obvious. If we improve our development process, we improve our trials. When we launch, manage, and close studies quickly and effectively, we get faster and better answers to pressing oncology treatment and prevention questions. 

Given the complexity of cancer trials today – translational medicine components, genomic testing, patient reported outcomes, drug registration data, etc. – protocol management is more important than ever. 

Here is a summary of what we’ve accomplished to date:

- Offered member training on developing biomarker-driven trials and master protocols

- Hired Norb Strauss, our assistant director of operations, to oversee operations office staffing and free up Dana Sparks, our operations director, to focus on strategy and process improvement

- Added four positions to the protocol team, which allowed us to change our department structure from a single manager to a trio of protocol project managers, and bring in more new protocol coordinators to beef up trial development and management capabilities

- Rolled out Office 365 to committee chairs, a process that will continue in 2020, to improve protocol development communication, cooperation and sharing of best practices.

- Created a new protocol resources page on SWOG.org which serves as a one-stop-shop for web pages and documents frequently used in protocol development

- Created a variety of dashboard to allow chairs to better monitor protocol development progress

There is more to come.

Starting in January 2020, SWOG’s update emails will now link members to the CTEP website for all protocol documents, reflecting a change in policy and practice at the National Cancer Institute, which now serves as the sole repository for our studies. In the new year, we will also further update our protocol development policy. 

Finally, we will begin the work of adding “triage”-related documents to the protocol tracking process. On our weekly executive (triage) calls, scientific leaders vote on whether to approve a trial concept and send it to NCI for review. By adding the documents to our work flow and tracking, we could get decision letters back to SWOG investigators the next day – shaving days or even weeks off our development time.

My thanks to Dana, Norb, and protocol project managers Sandi Hita, Crystal Miwa, and Vanessa Benavidez, as well as Nathan Eriksen, our chief of administration, and Casey Dawson, our assistant director of administration, for their hard work on making these improvements. I’ll keep you updated in the new year on the many additional changes to come.