The coronavirus pandemic transformed clinical research and our clinical trials. In just a few weeks, the National Cancer Institute approved major changes to trial conduct, allowing for telehealth visits, shipment of oral trial drugs directly to patients, and transfer of some care to local physicians. This flexibility has kept patients on trials, and allowed new patients to join them, even with strict social distancing and safety rules in place in many states.

These and other changes – like digital consent forms and virtual audits – have a lot of us talking. Should we make some of these changes permanent? Can we? How do we apply lessons from this public health emergency to our trials going forward, making them cheaper, more accessible, and faster to complete? SWOG Cancer Research Network is working on it, as is the rest of the NCTN.

I’ve convened a working group to study the issue and make recommendations to the SWOG leadership team – recommendations we will then take to NCI Director Dr. Ned Sharpless. I’m leading the working group, which also includes: SWOG assistant director of administration Casey Dawson, Hope Foundation President & CEO Jo Horn, and Drs. Don Dizon, Cathy Eng, Mike Fisch, Mark Lewis, Craig Nichols, Lee Ellis and Jimmy Rae.

Our first call, held this month, was productive and positive. That’s because we had a head start. Dr. Eng and colleagues on the SWOG gastrointestinal committee are working on a white paper about NCI trial innovations noting that response to the coronavirus “shows how adaptable the cancer centers, physicians, and patients can be.”

In order to make trials safer and faster, while maintaining the integrity of both data and care, Eng and her GI team offer several ideas to institutionalize, including:

  • Creating a single software build for Epic electronic medical records so they include all orders for a study, reducing redundancy and removing bottlenecks
  • Making as many trial visits as possible virtual – basically any visit that does not require a scan, blood work, or IV treatment – to reduce the likelihood of COVID infection for patients and care providers and allowing more rural patient participation
  • Capturing patient-reported outcomes and adverse events on smart phone apps
  • Capturing the results of next-generation sequencing tests electronically, so that patients can be matched to clinical trials
  • Maintaining oral drug shipment directly to patients, and continuing to allow for remote audits of trial sites

At the same time, members of the SWOG digital engagement, patient advocate, and recruitment and retention committees have been talking about post-COVID innovation, and I’ll be sure our working group hears their ideas.

As for execution, we’ll be able to make some changes here at SWOG on our own. But most will require the blessing of the NCI, and perhaps the FDA. Ideas like an NCI mobile or web app will also need funding.

I can’t predict what SWOG trials will look like in 2021 and beyond. But I can promise that – like so many things in life – our trials will not be the same, regardless of how quickly the COVID situation improves. We are not planning a return to “normal.” We’re actively planning for a new “normal,” one that is better for our patients.

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