Extraordinary Times, Extraordinary Measures
Much has changed since last week’s Front Line. The new coronavirus has spread to all 50 states, and the pandemic is affecting our clinical trials.
The National Cancer Institute has issued interim guidance on its NCTN and NCORP studies, which we’ve posted to a new COVID-19 clearinghouse on SWOG.org. This clearinghouse is an effort to serve you, our members and friends, by collecting and posting the latest information from SWOG, federal agencies, ASCO and other professional organizations, patient advocacy groups, and news outlets on the spread of, and response to, this new virus. It is aimed at the cancer care and research community. With so much news and opinion flying around online, we wanted to share, in one place, pertinent and credible information on cancer care and clinical trials at this unprecedented time. The clearinghouse will be updated daily, Monday through Friday, but be careful! Sometimes things change dramatically in less than a day. I do hope it’s useful to you.
SWOG and the NCI are working to support health care workers and institutions, as they focus their resources and attention on a pandemic response. The group chairs had a call last Friday with NCI leadership to discuss operations issues for all NCTN and NCORP trials. Here is some combined information arising from that call, the NCI’s March 13 guidance document, and our own leadership discussions here at SWOG:
- It would be naïve to expect accrual to continue unabated. Nonetheless, treatment as part of a study is often the best option for our patients with cancer, and some trials continue to do remarkably well
- Patient care may be transferred to a different participating study site.
- CTEP is allowing local physicians to administer standard therapies, conduct exams, and run the standard lab tests called for on its treatment trials, as long as local care physicians are following protocols and get agreement from a treating physician approved to participate in the trial. All data resulting from this care, including adverse events, must be sent to the study physician(s).
- Similarly, standard radiation and surgery, not requiring protocol-specified credentialing, may also be performed by the local healthcare provider with oversight by the responsible investigator.
- Oral investigational agents under an NCI IND agreement can be shipped from NCI to the trial site and may be forwarded from the trial site pharmacy to the patient.
- Intravenous investigational medications, however, must be administered at NCI-approved treatment sites only.
- CTEP is allowing sites to reschedule audits as necessary – and also reminding sites to record reasons for any protocol deviations. Audits will (eventually) happen!
- NCI is still considering the optimal use of telemedicine.
- NCI reports there are no cancer drug shortages or supply issues at this time.
- CTEP will hold calls regularly with NCTN group chairs and the operations offices, and I will continue to share key decisions and issues here on Front Line.
I can report that SWOG and our partners at The Hope Foundation for Cancer Research are virtually but essentially fully operational. Every office has transitioned seamlessly to remote work, and our team has done an amazing job organizing a virtual April group meeting. You can see a full schedule of conference call sessions on our spring meeting page. If you don’t see your committee listed, it’s because committee leadership decided to move business to regularly scheduled calls or otherwise skip its special session. Individual open meeting agendas will be posted to our spring meeting page as they come in and will be sent directly to committee members with conference call information. The spring meeting page also includes a group meeting FAQ, which includes contact information for key staff, as well as publications and accrual data typically found in the agenda book.
I am proud of the resiliency, professionalism, and optimism that the SWOG and Hope staff are showing at this difficult time. And I am immensely grateful to you. I know everyone reading this has seen their professional and personal lives upended. But our work remains vital. Thank you for your service!