NIH funding opportunities (2) – Serious Adverse Drug Reaction Research (R01, R21)

May 23, 2016 by School of Medicine Webmaster

The description below was taken from the R01 version of this FOA:

The objective of this FOA is to encourage research projects addressing current gaps in our knowledge of serious ADRs, particularly those that are idiosyncratic. These gaps exist along the translational spectrum. Potential areas of study include, but are not limited to, basic research into the immunologic, cellular, molecular, and toxicological mechanisms underlying serious ADRs, the identification of biomarkers and other population aspects of genetic susceptibility/pharmacogenomics and epidemiology of serious ADRs, and the development of therapies and interventions to treat and prevent serious ADRs. Within the broad range of objectives outlined above, applications must be within scope of the participating Institutes/Centers delineated below. Potential applicants are encouraged to contact IC scientific representatives for further information.

NCI welcomes applications for pre-clinical, translational, and clinical research on: mechanisms underlying serious ADRs, including organ toxicities and immune-related ADRs, resulting from anti-cancer therapies; discovery and integration of informative biomarkers for prediction, early detection, or monitoring of ADRs; development and validation of clinical assays or tools for measuring these ADR markers; and development of interventions for alleviation of severe and/or chronic ADRs in cancer patients.  Other areas of NCI interest include: development, testing, interpretation and the use of patient-reported outcome (PRO) measures to capture symptomatic toxicities, such as fatigue, nausea and neuropathy, in cancer patients; and epidemiologic surveillance over time of serious ADRs.

NHGRI welcomes applications that focus on genetically mediated severe ADRs. Studies that focus on a specific severe ADR should be paradigm setting and yield findings of relevance to the broader field of ADR research. Topics of interest include, but are not limited to, establishment of case registries or cohorts for the primary purpose of identifying or characterizing genetic markers for ADRs, particularly in minority and health disparity populations, identification of modifiers of risk alleles, implementation and evaluation of genetic tests for screening in clinical settings, studies of health and economic outcomes of genetic screening, and integration of genetic results in the electronic health record for use in clinical care. Pharmacogenomic studies of antiretrovirals and AIDS related applications are encouraged.

NIAID welcomes applications in the basic, translational and clinical study realms that investigate the immunologic bases of severe ADRs. General areas of interest include: diagnosis of drug allergy and true incidence of IgE-mediated reactions, mechanisms of development of IgE-mediated reactions and mechanisms of drug-induced anaphylaxis, innate and adaptive immune responses to drugs, impact of infectious or inflammatory conditions on immune responses including the effect of HIV infection on ADR specific processes, development of biomarkers that aid in diagnosis or that predict risk or response to therapy, investigations into drug-initiated autoimmune reactions, and immunomodulatory approaches to the management of severe ADRs.

NIAMS welcomes applications that focus on pre-clinical studies of severe ADRs that target the mucocutaneous surfaces. Main areas of interest include the elucidation of cellular and molecular mechanisms leading to epidermal and epithelial cell apoptosis and necrosis, the characterization of key pathogenic signal transduction pathways, the investigation of cellular and molecular signatures that can predict ADRs acute phase, the generation of in vivo and in vitro models to better understand ADRs mechanisms of action, and the identification, optimization and development of therapeutic strategies for the treatment of ADRs.

NIMHD welcomes applications for clinical and translational projects focused on discovery, risk prediction, early detection, prevention and treatment of ADRs in minority and/or health disparity populations (African Americans, Hispanics, American Indians, Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, and rural populations). Research topics of interest include identification and validation of biomarkers of ADRs in minority and/or health disparity populations (e.g., informative genetic ancestral markers, epigenomic alterations, metabolomic profiles, gut microbiome profiles, pharmacokinetic and pharmacodynamic biomarkers), genetic screening approaches, drug-drug interactions, drug-diet interactions, and mechanistic studies of ADRs.

NINDS welcomes applications that focus on studies of severe, life-threatening ADRs that investigate the mechanisms by which FDA-approved medications cause pathological changes to the central and/or peripheral nervous system in individuals with neurological disorders or in animal models.  Other areas of NINDS interest include:  identification and validation of biomarkers of severe ADRs in the setting of neurological disorders and elucidation of the cellular and molecular mechanisms leading to pathological changes in the nervous system in response to severe ADRs.  Studies of interest that would be in scope include, but  are not limited to:  mechanisms underlying optic neuritis or other brain lesions observed on MRI in infants taking vigabatrin for infantile spasms, mechanisms for and biomarkers of SJS/TEN development in individuals with epilepsy taking anticonvulsant medications, and seizure from theophylline while taking erythromycin. Translational grants on assay development, target engagement, animal model development, or PK/PD studies should NINDS translational grant mechanisms (see: ), and clinical trials should utilize specific NINDS clinical trial mechanisms (see:

Deadlines:  letters of intent are due 30 days before the deadline for full proposals, which fall on the following dates – October 4, 2016; February 1, 2017; June 1, 2017; October 2, 2017; February 1, 2018; June 1, 2018; October 1, 2018; February 1, 2019; June 3, 2019


Filed Under: Funding Opportunities