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Innovative Research Methods: Prevention and Management of Symptoms in Chronic Illness (R15)

Grant Amount: Unspecified.

This funding opportunity seeks to update the randomized control trial (RCT) design using novel research methods that are practical, innovative, and hold promise for producing more effective outcomes. Novel clinical research designs, applied to symptom management trials, may identify those treatment strategies that best alter the course of symptom burden in chronic illness by addressing the issues of varied treatment responses across patients, subject retention, and adherence to treatment regimens. For example, “sequential multiple assignment randomization trials” (SMART) design have been used successfully to develop dynamic treatment regimens for alcohol, depression and HIV infection but are not widely used in symptom management trials. The approach is pragmatic in that it mimics clinical practice by allowing a re-evaluation of treatment options based on an individual’s progress towards treatment goals. The levels or inclusion of intervention components are tailored in response to individual characteristics or progress toward a treatment goal. Subjects may be randomly assigned several times to varying amounts and types of intervention components based on predetermined decision rules. This “sequential decision making” process allows for the initial intervention to be adapted and provides subjects with options for achieving a favorable outcome. A “Multiphase optimization strategy “(MOST) could also prove useful when applied to symptom management trials. This design leads to identification of a likely best intervention that can be evaluated at optimal levels in an RCT, through an iterative process of empirical research and discovery. In addition large scale Electronic Health Records (EHR) enabled research and other data mining efforts to identify likely best interventions that could be further tested in clinical trials is needed. The screening of viable treatment regimens and strategies from observational databases has the potential to find patterns of treatment and perhaps the optimal, naturalistic sequencing strategies used in current practice for managing symptoms. These natural trends in treatment variation may form the basis of explicit dynamic treatment regimens that can be tested in comparative trials. Finally comparative effectiveness research is needed to enhance trials that seek to determine the most potent intervention(s) for symptom prevention and management in chronic illness. Determining these interventions through comparative effectiveness research will inform healthcare decisions by providing evidence on the benefits and harms of different treatment strategies.
Funding Organization
US Department of Health and Human Services
Public Health Service
National Cancer Institute
National Institutes of Health
Office of Communications
National Institute of Nursing Research
Fund Category
Support Types
Eligible Organizations
Educational Organizations/Institutions
Award Amount Notes
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Applicants may request up to $300,000 in direct costs plus applicable Facilities & Administrative (F&A)/indirect costs for the entire project period of up to 3 years. Note when a consortium is involved, the $300,000 direct cost limit is exclusive of consortium F&A costs. These can be requested in addition to the $300,000 direct costs limit.
Application Due Date
Project Start Date
Application Contact
Phone: (301) 435-0714
Technical Contact
Susan Marden
Program Director
Office of Extramural Activities NINR

Phone: (301) 496-9623
Fund Duration
Up to 3 years.
Alcohol Abuse
Clinical Research
Disease Prevention
Medical Treatments and Therapies
Application Process
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Companion Funding Opportunity: PA-13-165, R01 Research Project Grant; PA-13-167, R21 Exploratory/Developmental Grant
Web Site
Fund Number

Disclaimer: NPIN provides this information as a public service only. The views and information provided about the materials, funding opportunities, and organizations do not necessarily state or reflect those of the U.S. Department of Health and Human Services, CDC, or NPIN. Fund Record #4693

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