The following are statements from NCI on the state of clinical trials and funding during the COVID-19 pandemic.
“Cancer patients are particularly vulnerable to infectious diseases such as COVID-19, both because of their underlying health condition and because cancer treatments can suppress the immune system. At this time, we do not know how the COVID-19 pandemic will evolve or the extent to which it will place stress on cancer patients, their families, and their caregivers.
“The Centers for Disease Control and Prevention and other public health experts have provided authoritative advice on how individuals can protect themselves. Patients should seek advice from their health care providers regarding their individual care and whether they should be tested for COVID-19.
“A patient’s health care team is best suited to evaluate that individual’s unique situation and advise on the safest course of action. As more information becomes available on mitigation strategies from physicians caring directly for cancer patients, that information will be shared broadly in the oncology community. For example, researchers at the Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, and the University of Washington have published information about managing cancer care during the COVID-19 pandemic, and NCI is closely monitoring the clinical experience of cancer caregivers across the world.
“For individuals undergoing treatment for cancer, the spectrum of acute need for cancer treatment is broad. In some situations, it is essential that patients receive treatment immediately for their cancer. In other situations, such as for patients who are not receiving active treatment, visits for follow-up cancer care may be safely delayed. Patients should discuss individual treatment plans with their health care team.
“During the challenging situation of the COVID-19 pandemic, we understand that health care system resources will be limited, and this may affect cancer clinical trial operations. We do, however, believe that there are circumstances (e.g., in order to access potentially life-saving therapy) where patients with cancer should enroll or continue to participate in a clinical trial. Advice given to patients participating in clinical trials should be tailored to the individual patient based on their clinical circumstances.
“On March 18, the Food and Drug Administration issued guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic. In addition, NCI has provided guidance for clinical trials’ activities during the COVID-19 pandemic, with the intent of giving greater flexibility to the patient and their caregiver so that they may more easily be treated on a clinical trial if indicated.
“We continue to closely monitor NCI-supported clinical trials to help address the needs of investigators to implement accommodations so that they can, to the greatest extent possible, maintain continuity of care for their patients who are being treated on trials. If a clinical trials site’s policies and practices vary from the guidance we have outlined, they are encouraged to contact NCI’s Cancer Therapy Evaluation Program.”
NCI’s Sharpless vows to support extramural research through crisis
NCI Director Ned Sharpless issued a statement outlining NCI’s strategy for responding to the COVID-19 pandemic:
“As we understand so well, biomedical research improves public health through scientific discovery. The COVID-19 pandemic only reinforces the importance of our work and the work of so many others who are dedicated to protecting and improving public health. I want to assure you that NCI, in partnership with NIH, is taking affirmative steps to support the extramural cancer research enterprise during this challenging time.
“I encourage you to read the recent post on NIH’s Open Mike blog about NIH operations during this public health emergency. NIH has established a comprehensive resource with guidance for grant applicants and funding recipients on NIH grant operations. I also recommend checking this resource often over the coming weeks, as additional notices will be posted on a regular basis.
“At NCI, we are committed to sustaining progress against cancer, now and always. With this commitment in mind, earlier this month I asked NCI Principal Deputy Director Doug Lowy, M.D., to lead an NCI task force with a broad mandate, which includes maintaining the continuity of NCI operations during this public health emergency, including operations that support NCI extramural research.
“I am also deeply involved, working with other NIH institute directors and our colleagues at the Department of Health and Human Services as we respond to evolving developments related to COVID-19. NCI employees continue to work, many teleworking from home, to sustain our interactions with the extramural community.
“With that background, let me share a few updates on NCI extramural operations given the rapidly evolving situation we are witnessing.
“The NCI Division of Extramural Activities will ensure that all previously scheduled peer review meetings proceed using one of three alternate meeting formats that NIH identified: telephone-assisted, virtual, or video-assisted. Reviewers can find more information on these formats on the NIH Tools and Technology web page.
“If you are participating in the peer review of applications submitted to NCI, we ask you to please be flexible about the scheduling and the meeting format so that incoming applications can continue to be reviewed in a timely way.
“Once peer review is complete and grant applicants have access to summary statements, applicants should contact the appropriate NCI program director. Applicants will find contact information for the program director in the top left corner of the summary statement.
“If you are not sure whom to contact, the appropriate contact for your application can be found on our Grants & Training webpage.
“If you have questions regarding grant applications you submitted, please pose your questions through eRA Commons.
“The NCI Office of Grants Administration continues to issue grant awards, revisions, and post-award actions. NCI staff will be following the NIH guidance on coronavirus administrative flexibilities related to grant awards.
“If you have questions about your awarded grant, please contact the grants management specialist listed on your Notice of Award. If you aren’t sure who your assigned specialist is, please visit Grants Management Contacts on our Grants & Training webpage.
“Although we are facing truly exceptional circumstances, in the United States and globally, I am confident that we will weather this crisis together and grow stronger as an international cancer community. And let me also express my heartfelt gratitude for your continued dedication to your work and our nation’s health during these trying times.”
