Notice Number: NOT-CA-20-026
Release Date: February 21, 2020
First Available Due Date: May 25, 2020
Expiration Date: May 08, 2023
PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-18-722 Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (R01 Clinical Trial Optional)
PAR-18-869 Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)
PAR-18-559 Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)
PA-19-053 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
PA-18-723 Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (R21 Clinical Trial Optional)
PAR-19-309 Stimulating Innovations in Behavioral Intervention Research for Cancer Prevention and Control (R21 Clinical Trial Optional)
PAR-20-052 NCI Small Grants Program for Cancer Research for Years 2020, 2021, and 2022 (NCI Omnibus R03 Clinical Trial Optional)
PAR-20-077 National Cancer Institute Program Project Applications (P01 Clinical Trial Optional)
NATIONAL CANCER INSTITUTE (NCI)
The purpose of this Notice is to inform potential applicants of the special interest of the National Cancer Institute (NCI) in promoting research on understanding and enhancing oral anticancer medication utilization, adherence, and health care delivery.
There are currently more than 50 U.S. Food and Drug Administration (FDA)-approved oral anticancer agents and it is expected that the rate of development, approval, and use of these medications will continue to increase. Achieving maximal benefit of oral anticancer agents requires that they are prescribed, administered and monitored properly. To pursue and accomplish this goal, it is necessary to track, utilize, and identify factors that influence adherence and that enhance care delivery systems that improve appropriate and safe use of these agents by both clinicians and patients. Research projects should advance actionable knowledge regarding the utilization, adherence, and/or care delivery of oral anticancer agents
There is little information about the adoption of newly approved oral agents, particularly those approved through an accelerated pathway, and the provider factors influencing utilization of these new therapies. Despite the targeted nature of many of these agents, use of these drugs may be accompanied by adverse events that are often unknown until the drugs have been widely used. In addition, there is scant information about the effect of genomic testing on off-label use of oral anticancer agents, as well as patient and provider characteristics associated with off-label prescribing
Adherence to oral anticancer agents, particularly molecularly targeted therapy, is critical to achieving an optimal clinical outcome. Suboptimal adherence may not only lead to poor survival, but to side effects and toxicities, unnecessary treatment changes, increased use of health care resources, and decreased patient satisfaction. The complexity of many oral anticancer regimens and the difficulty managing side effects of these drugs in the home have been strongly associated with suboptimal adherence, which may result in therapeutic failure.
Traditional parenteral therapy is administered in controlled clinical settings with the oncologist, nurses, and pharmacists providing care according to national safety standards. However, oral anticancer agents are often administered and monitored by patients and caregivers in the home. There is an emerging need for health care systems to establish new roles and responsibilities, models of care, technology support, patient education strategies, and interventions for coordinating care of these patients.
This Notice invites research applications that: characterize the patient and provider factors influencing utilization of oral anticancer agents; identify structural, systemic, and psychosocial barriers to adherence; and/or develop models and strategies to improve safe and effective delivery of oral anticancer agents. Research may be focused at the patient (pediatric, adolescent, young adult, and/or adult), patient-caregiver dyad, provider, health care team, and/or health care delivery system levels. Research that merges expertise from diverse areas of science and clinical disciplines (e.g., pharmacy, nursing, oncology, primary care) or is focused on molecularly targeted agents is not required, but strongly encouraged. Addressing the needs of groups subject to disparities, such as the elderly or medically underserved, is an NCI priority.
Areas of interest include, but are not limited to, research that falls in one or more of the following three categories.
Application and Submission Information
This notice applies to due dates on or after June 5, 2020, and subsequent receipt dates through January 8, 2023.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice
|First Available Due Date|
|R01||PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)||
June 5, 2020
|R01||PA-18-722 Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (R01 Clinical Trial Optional)||
June 5, 2020
|R01||PAR-18-869 Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)||
November 6, 2020
|R01||PAR-18-559 Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)||
June 5, 2020
|R21||PA-19-053 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)||
June 16, 2020
|R21||PA-18-723 Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (R21 Clinical Trial Optional)||
June 16, 2020
|R21||PAR-19-309 Stimulating Innovations in Behavioral Intervention Research for Cancer Prevention and Control (R21 Clinical Trial Optional)||
June 16, 2020
|R03||PAR-20-052 NCI Small Grants Program for Cancer Research for Years 2020, 2021, and 2022 (NCI Omnibus R03 Clinical Trial Optional)||
June 16, 2020
|P01||PAR-20-077 National Cancer Institute Program Project Applications (P01 Clinical Trial Optional)||
May 25, 2020
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
Although NCI is not listed as a Participating Organization in all the FOAs listed above, applications for this initiative will be accepted.
Please direct all inquiries to:
Peer Review Contact(s):
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact:
National Cancer Institute
Office of Grants Administration