Key Dates

Related Announcements

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

NOT-DK-20-051 - NIDDK Investigator-Initiated Multi-Center Clinical Studies Revised Guidance

Issued by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

This Notice announces the participation of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in PA-20-183, "Research Project Grant (Parent R01 Clinical Trial Required)".

High-risk multi-center clinical trials in the mission of NIDDK should be submitted to and will be supported through PAR-21-102. As announced in NOT-DK-20-051, multi-center clinical trials (i.e., more than one center) that are considered high-risk will be required to use a two-part, cooperative agreement process.

As explained in NOT-DK-20-051, the risk level of a study may be related to interventional and/or operational risk. The examples below provide general guidelines for risk assessment and are not exhaustive. Potential applicants are strongly encouraged to contact NIDDK staff to discuss their proposed study and determine the most appropriate mechanism for submitting their application.

Examples of high-risk interventions include:

• An intervention that has an unknown safety profile or has substantial side effects (including all studies requiring an IND/IDE application). This would include studies of a drug in a new population, or study of a licensed product for an unapproved indication;
• A complex or invasive intervention, including diagnostic procedures;
• A study involving complex assessment of multiple outcomes, including the ascertainment of outcomes using invasive research procedures;
• Pragmatic trials proposing significant changes to standard of care practices, or significant coordination with multiple care providers and healthcare data systems;
• A multi-center study involving more than minimal risk in vulnerable study populations (as defined in 45 CFR 46)

Studies that do not meet the above criteria will generally be considered to involve low-risk interventions. Low-risk multicenter studies usually include the administration/use of a licensed product for an approved indication, or the provision of a routine intervention that could be used in the setting in which it is being studied (e.g., a lifestyle intervention to promote weight loss).

Examples of multicenter studies with high operational risk include:

• An inexperienced investigator, defined by lack of experience in conducting clinical trials, coordinating research across multiple centers, or recruiting the population to be studied;
• A complex study design that involves standardization of research measures and outcomes collection and research data capture over multiple centers;
• A study that involves the establishment of agreements with third parties that intend to utilize research study data to support regulatory filings with the FDA

Multicenter studies that do not meet the above criteria will generally be considered to have low operational risk.

A multicenter study is classified as high risk if it utilizes either a high-risk intervention or has high operational risk, or both.

NIDDK will only support research within its mission. 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. 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 and promote health equity. NIDDK has many research areas within its mission, but all research related to relevant diseases may not be appropriate for NIDDK. Applicants are strongly encouraged to contact NIDDK staff as soon as possible in the development of the application, so that NIDDK staff can help the applicant understand whether the proposed clinical trial is within the goals and mission of the Institute and which FOA is most appropriate.

The following sections of PA-20-183 have been modified (shown in italics) to reflect the NIDDK's participation in this FOA:

Components of Participating Organizations

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

The following Institutes/Centers only accept mechanistic studies that meet NIH's definition of a clinical trial. See Related Notices section below.

National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Mental Health (NIMH)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.213, 93.867, 93.172, 93.233, 93.840, 93.837, 93.838, 93.839, 93.866, 93.273, 93.855, 93.846, 93.847, 93.279, 93.113, 93.859, 93.307, 93.853, 93.361, 93.242

All other aspects of this Funding Opportunity Announcement are unchanged.

Inquiries

Please direct all inquiries to:

Barbara Linder, M.D. Ph.D
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301 594-0021
Email: [email protected]


Tracy L. Rankin, M.P.H, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301 594-4748
Email: [email protected]

Aynur Unalp-Arida, M.D., Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301 594-8879
Email: [email protected]