March 14 2020
NRG Oncology Community;
We wanted to share our current thoughts and plans related to the impact and preparedness of NRG Oncology as the COVID-19, or Coronavirus, outbreak has escalated to a pandemic. We truly thank all of you for your continued commitment to your patients in alignment with NRG Oncology’s mission in this time of heightened concern.In addition to guidance from the NIH/NCI as our granting agency, we are ensuring alignment with the US Centers for Disease Control (CDC) recommendations and keeping abreast of the fast-moving updates. We encourage following the recommendations therein found at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
We support our NRG member sites, vendors, subcontractors, and others working on our behalf in their activities to assess risk and implement steps that maximize the wellness and safety of patients, providers, staff, and their family members, as outlined by the CDC recommendations and in response to the local assessment of risk. At NRG Operations, and Statistical and Data Management Centers, we have encouraged and supported remote work and have tools available to support virtual collaborations and encouraged flexibility to allow staff to manage associated challenges and local requirements as necessary.
Many of our NRG Oncology leaders and investigators are engaged in preparedness planning and responding within their institutions and communities, and we appreciate these efforts to minimize risk to patients, staff, providers, and families. Non-essential meetings may be cancelled, and routine business may be put on hold in support of the
necessary focus within communities.
As always, decisions between patient and provider are made to ensure the continued health and well-being of patients, providers, and communities. During this time of heightened risk related to the COVID-19 virus, we realize protocol-specified visits may be deferred or cancelled. Member sites will not be penalized for data delinquencies or protocol non-compliance during this time period, but we encourage the continuance of protocol activities which can be safely completed. Alternative methods for obtaining the data may be suitable in the circumstances, such as through telehealth visits. Current guidance remains that protocol deviations must be documented and reported according to CIRB/local IRB requirements. We will update as appropriate. If you have specific questions related to a protocol, please contact the study team as listed on the protocol face page
We will provide leniency in accrual requirements as we better assess the impact of this pandemic.
Please also see the CTEP/NCORP guidance.
Study DrugThere is speculation that a downstream impact could/will be availability of study drug. We have not, at this time, received any reports related to NRG Oncology studies but are establishing a chain of communications to respond and provide guidance should that occur
Many professional meetings planned for this spring have been cancelled or have shifted to a virtual format. Several NCTN groups are shifting in-person group meetings to virtual formats or cancelled their group meetings entirely.
For NRG Oncology, a planned in-person meeting to be held mid-May for our soon-to-activate colon cancer prevention study, FORTE, has been shifted to a virtual meeting in response to the travel concerns from attendees. For the NRG Oncology semiannual meeting in mid-July, we will monitor the situation and are not taking new action at this time. We will explore alternative methods to support our meeting objectives if the situation requires it.
The NRG Audit Team has been handling audits on a case by case basis with input from the site and the audit staff. We will continue to assess and provide direction to impacted sites; this is likely to continue through the month of April, at least. We anticipate more specific guidance to be published next week. If you have questions about an upcoming audit, contact Mimi Passarello at email@example.com or 412-383-2189.
Thank you for all that you are doing on behalf of your patients and our mission, we wish you continued health!