This FOA invites applications for investigator-initiated clinical trials within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to be conducted at no more than two clinical research centers. NIDDK is committed to improving the health of people with diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic and hematologic diseases. Applications for clinical trials submitted under this FOA should be hypothesis driven, have clearly described aims and objectives, and have a high likelihood that the trial findings will improve understanding, diagnosis, prevention or treatment of the diseases studied and have the potential to impact clinical practice and/or public health.
NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). Applications submitted to this FOA may propose either therapeutic or mechanistic clinical trials. A therapeutic trial has a goal of determining clinical safety, tolerability, efficacy and/or effectiveness of an intervention designed to prevent or treat a disease or condition. Such studies may be pragmatic trials where the intervention is tested under the usual conditions in which it will be applied, or explanatory trials where the intervention is tested under idealized circumstances. Mechanistic trials are designed to understand a biologic process, the pathophysiology of a disease, or the mechanism of action of an intervention.
Examples of trials that are consistent with the intent of this FOA are:
- Clinical trials that test the safety, tolerability, dosing and/or efficacy of a new or re-purposed pharmacologic, biologic or surgical intervention, or a unique combination of therapies;
- Clinical trials to improve processes of care;
- Clinical trials of behavioral interventions to prevent disease, promote treatment adherence, and improve disease management or treatment;
- Clinical trials designed to test a biomarker, diagnostic test, or medical device that would improve disease/outcome risk-stratification, diagnosis, treatment or monitoring of treatment responses;
- Comparative effectiveness/pragmatic clinical trials of previously established therapies and/or testing the effect of these therapies among disease sub-groups; and
- Clinical trials where the primary objective is not to test the clinical efficacy or effectiveness of an intervention, but where the intervention is being used to understand a biological process (e.g., the pathophysiology of a disease or the mechanism of action of an intervention), if the goal is to assess a health-related outcome.
Many of the diseases within the mission of NIDDK disproportionately affect individuals from racial and ethnic minorities. NIDDK encourages research focusing on minority and underserved populations, and places a high priority on clinical trials to understand and eliminate health disparities.
This FOA is not intended for observational studies, which may be submitted as R01s to the NIH parent R01 FOAs or other relevant NIH FOAs. Other types of human subjects research that do not fit the NIH definition of a clinical trial may also be submitted to the NIH parent R01 Clinical Trial Not Allowed FOA.
This FOA is not intended for the support of activities required for the development of the clinical trial, such as designing the study, writing the protocol and informed consent documents, or identifying participating sites. The rationale and design of the proposed trial must be supported by strong preliminary data. This FOA is not for pilot and feasibility studies. Investigators who need to collect preliminary data or conduct pilot and feasibility studies may consider one of the NIDDK FOAs for R21s (https://www.niddk.nih.gov/research-funding/current-opportunities).
Only clinical trials to be conducted with one or two distinct clinical research centers are permitted under this announcement. Multi-center trials are not appropriate to this FOA and will not be supported. For the purpose of this FOA, a clinical research center may encompass one or more physical locations where the clinical trial is being conducted — i.e., where study participants are recruited, and/or are intervened upon and/or have outcomes assessed under a single protocol – as long as all locations are under the overall direction of a single investigator. Under this announcement, multi-center clinical trials are defined as those that include three or more clinical research centers where recruitment, intervention delivery and participant assessment occur under the direction of investigators from three or more separate research centers, each responsible for the overall conduct of their center’s performance. A data coordinating center is not considered a clinical research center. Applications for clinical trials requiring three or more centers should be submitted to NIDDK multi-center clinical study implementation planning cooperative agreement (U34) and NIDDK multi-center clinical study cooperative agreement (U01) FOAs, as explained in Notice DK-14-025 (see http://grants.nih.gov/grants/guide/notice-files/NOT-DK-14-025.html) or other FOAs that allow multi-center studies.
This FOA will only support research within the mission of NIDDK. Research applications in areas that are primarily within the missions of other NIH Institutes and Centers are not appropriate for this FOA and will not be supported.
NIDDK has a major interest in diabetes and its complications, but research on most organ-specific diabetes complications, with the exception of diabetic nephropathy, is within the mission of other NIH ICs. For example, research on diabetic retinopathy should not be submitted to NIDDK, but may be appropriate for NEI. Research on cardiovascular disease, cardiomyopathy, cardiac autonomic neuropathy, hypertension or dyslipidemia should not be submitted to NIDDK, but may be appropriate for NHLBI. Research on endocrine cancers should not be submitted to NIDDK, but may be appropriate for NCI. Research focusing on the primary prevention or treatment of gestational diabetes directed at the immediate pregnancy outcomes of women or their newborns should not be submitted to NIDDK, but may be appropriate for NICHD. Reproductive endocrinology is not within the mission of NIDDK and studies on this topic will not be supported under this announcement.
NIDDK has a major interest in obesity research, but research on obesity-related endpoints outside of the mission of NIDDK should be submitted to other NIH ICs. For example, research on the pathogenesis, prevention, or treatment of obesity-related cardiovascular disease, hypertension, asthma, or heart failure should not be submitted to NIDDK, but may be appropriate for NHLBI, research on obesity-related musculoskeletal disorders should not be submitted to NIDDK, but may be appropriate for NIAMS, and research on use and abuse of alcohol after bariatric surgery should not be submitted to NIDDK, but may be appropriate for NIAAA. NIDDK is also interested in nutrition clinical trials that aim to treat diseases within the mission of NIDDK or improve health.
NIDDK is interested in clinical trials with translational potential and clinically meaningful endpoints for diseases of the alimentary tract, liver, and pancreas. Trials for cancer should not be submitted to NIDDK, but may be appropriate for NCI.
NIDDK is also interested in supporting clinical trials leading to the identification and evaluation of possible treatments to prevent the development and progression of kidney diseases and benign urological conditions. Trials focused solely on non-renal outcomes and endpoints in populations with kidney disease are not supported under this announcement and should be submitted to the appropriate IC. Transplantation trials focused on processes and mechanisms of acute or chronic rejection of kidneys, or on immune-mediated diseases, where the kidney is not the focus of the investigation should not be submitted to NIDDK, but may be appropriate for NIAID. Trials involving malignant diseases of the kidney and urologic organs should not be submitted to NIDDK, but may be appropriate for NCI.
Deadlines: Standard dates and AIDS dates apply.
Filed Under: Funding Opportunities