NRG Oncology COVID-19 Updates

For Patients

(Updated 3/23/2020)

We understand that as a patient or family member of a patient participating in – or considering participatingin, a research study may have questions related to your care and/or ability to complete the requirements of the research study given the current pandemic.  See also the information linked below for cancer patients from the National Cancer Institute.

Medical facilities are instituting changes in how they operate in response to local risk, local or state requirements, and types of essential activities carried out at that particular facility. You should always check in if you have questions or concerns, according to what your research physician or other representative of your medical facility has directed you to do.

Some potential changes that may occurfor clinical trial participants are highlighted below:

    • Transferring care
      Care may be transferred for a specific visit or it may be fully transitioned to a new facility.
      • Local Healthcare Provider assumes your care.  For a patient already on a clinical trial, the Research Physician/Provider may make arrangements for a non-Research healthcare provider to provide care. This may be appropriate if someone cannot travel or due to changes at the medical facility is necessary as deemed by your research physician/care provider. Such arrangements are generally short-term or intermittent in nature.  Your current research physician remains responsible for your care on the research study.
      • Your physician or physician’s office may, in some cases, notify you that your care is being transferred elsewhere during this pandemic. Our clinical trials are open at many different facilities, and you may be able to continue with the research study. If the study is not currently open at your new facility, it may be possible that it could be – talk to your care provider. You can also see institutions where research studies are open here.
    • Use of telemedicine
      The use of telemedicine – using technology to diagnosis and treat patients remotely- is not new, but may be newly implemented at some medical facilities in response to the current pandemic. You may be asked about this, and provided information as to how to do medical appointments remotely. You may also ask your care provider about it if you are interested.

    • Closing some or all research studies
      You may learn that your research study is being suspended or closed due to insufficient ability to support it at this time. You may be provided information to transfer your care to a facility that can support your research study participation, or you may ask about that if you are notified of your facility closing your research study – see Transferring Care above, as well. 

    • Delay or cancel of research related appointment
      Many offices are finding it necessary to cancel or delay research related appointments. We are working closely with all of our collaborating sites to understand and support these necessary changes, and to also figure out ways to allow us to continue to support the conduct of research that over a long-term will provide valuable information to how we care for cancer patients. 

Also see guidance for Cancer Patients from the National Cancer Institute

For our NRG Oncology Member Sites

(Updated 3/26/2020)

NRG Oncology remains committed to supporting your research efforts, whatever that may look like at your institution today. While the pandemic is commanding time, energy, and resources across the country and the world right now, the conduct of clinical research is a long-term commitment.  Together, we will weather this storm and do our best for patients, Member Sites, study teams, and staff - and get to those research outcomes as best we can.

Protocol-specific guidance will be provided through the CTSU as always, and disseminated through our weekly broadcast or more frequently as required.  This webpage links to the current guidance we are following from the NCI and CIRB. Come back often real-time updates will be posted here.

    • Protocol Deviations
      First and foremost, consider taking steps and/or actions that are in the best interest of patients and follow local institutional guidance and procedures. Document protocol deviations and report deviations to the IRB of record.  Deviations will be considered in light of the COVID-19 situation and required responses, such as development of Corrective and Preventive Action (CAPA) plans,  will be more lenient. The NCI and the NCI CIRB have posted Interim Guidance which is available on the NCI's website: https://ctep.cancer.gov/. The NCI, the NCI CIRB, and NRG Oncology are all working diligently to provide further guidance to assist during this time period and updates will be provided as soon as they are available. 

    • Biospecimen Banking 
      Click here for more information on Biospecimen Banking updates. 

    • Audit
      Many audits have been postponed and we will work with you to determine new dates in the future. Re-audits of regulatory documentation and/or pharmacy records will continue on schedule as these are performed off-site.  If you can arrange remote access to the research records, we may conduct your audit remotely.  If your audit consists of three or fewer patient cases, we may contact you to request records be sent to us if you are agreeable to conducting your audit off-site. If you have any questions, please contact Mimi Passarello, passarellom@nrgoncology.org or Janet Famiglietti, famigliettij@nrgoncology.org 

    • Accrual
      During this time, it is anticipated that accrual to clinical trials will drop.  NRG Oncology will provide leniency in terms of membership accrual resulting from the pandemic

    • Patient Transfers
      Click here for more information on Patient Transfer updates.

    • Drug Distribution
      Please see the previously distributed NCI NCTN and NCORP Interim Guidelines for NCI-supplied oral and investigational agents for NCI-supplied oral and investigational agents. NRG Oncology held protocols will follow the same interim guidelines unless otherwise noted within the protocol. 

    • Telemedicine
      The use of telemedicine where appropriate and in accordance with local institutional guidance is a strategy being used by many facilities to manage routine follow up of patients, in some cases including research participants. If a protocol currently requires in-person follow up but that visit is conducted through telemedicine, currently it will be a protocol deviation – see guidance related to protocol deviations. Over time, we hope to amend protocols to assist in decreasing the occurrence of such visits being non-compliant where appropriate. We expect further guidance to develop. Make sure to document any visits conducted using telemedicine as such.

    • Semiannual Meeting
      NRG Oncology’s Semiannual Meeting is currently scheduled to occur July 16-18, 2020. At this time, NRG Oncology has not made any changes to the planned meeting.  If changes are required, we will make announcements closer to time. 

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