Explore the vast range of titles available.

The use of digital health products has gained considerable interest as a new way to improve therapeutic research and development. Although these products are being adopted by various industries and stakeholders, their incorporation in clinical trials has been slow due to a disconnect between the promises of digital products and potential risks in using these new technologies in the absence of regulatory support. The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium hosted a public workshop to address challenges and opportunities in this field. Important characteristics of tool development were addressed in a series of presentations, case studies, and open panel sessions. The workshop participants endorsed the usefulness of an evidentiary criteria framework, highlighted the importance of early patient engagement, and emphasized the potential impact of digital monitoring tools and precompetitive collaborations. Concerns were expressed about the lack of real‐life validation examples and the limitations of legacy standards used as a benchmark for novel tool development and validation. Participants recognized the need for novel analytical and statistical approaches to accommodate analyses of these novel data types. Future directions are to harmonize definitions to build common methodologies and foster multidisciplinary collaborations; to develop approaches toward integrating digital monitoring data with the totality of the data in clinical trials, and to continue an open dialog in the community. There was a consensus that all these efforts combined may create a paradigm shift of how clinical trials are planned, conducted, and results brought to regulatory reviews.

NIMH’s mission is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. New imaging techniques hold great promise for improving our understanding of the pathophysiology of mental illnesses, stratifying patients for treatment selection, and developing a personalized medicine approach. Here, we highlight emerging and promising new technologies that are likely to be vital in helping NIMH accomplish its mission, the potential for utilizing multimodal approaches to study mental illness, and considerations for data analytics and data sharing.

The Biomarkers Consortium aims to facilitate drug development with biomarkers across a range of diseases. Here, we briefly highlight its accomplishments so far and its recent expansion in scope to include related tools along the lines of the Biomarkers, EndpointS and other Tools (BEST) resource, such as patient-reported outcomes and clinical outcome assessments.The Biomarkers Consortium aims to facilitate drug development with biomarkers across a range of diseases. Here, we briefly highlight its accomplishments so far and its recent expansion in scope to include related tools along the lines of the Biomarkers, EndpointS and other Tools (BEST) resource, such as patient-reported outcomes and clinical outcome assessments.

The purpose of the Molecular Libraries Initiative component of the NIH Roadmap for Medical research is to expand the availability, flexibility, and use of small-molecule chemical probes for basic research. Because this initiative is particularly novel and far-reaching, it has been the subject of considerable discussion, and sometimes misinterpretation in the research community. Austin et al explain that the NIH Molecular Libraries Initiative is a bold initiative to catalyze science in the genome era.

There is an urgent need to transform basic research discoveries into tools for treatment and prevention of mental illnesses. This article presents an overview of the National Institute of Mental Health (NIMH) programs and resources to address the challenges and opportunities in psychiatric drug development starting at the point of discovery through the early phases of translational research. We summarize NIMH and selected National Institutes of Health (NIH) efforts to stimulate translation of basic and clinical neuroscience findings into novel targets, models, compounds, and strategies for the development of innovative therapeutics for psychiatric disorders. Examples of collaborations and partnerships among NIMH/NIH, academia, and industry are highlighted.

Relating a clinical domain to a circuit that can be interrogated in humans and models provides a possible approach to explore the role of glutamate in “antidepressant” action. [...]given the diffuse role of this excitatory amino acid, one could seek a defined domain of behavior linked to a brain circuit that can be up- or down-regulated by a specific glutamate receptor agent. Ketamine has long been of interest outside of its use as a “dissociative anesthetic” to induce altered states in humans that are seen as mimicking components of psychosis as well as producing other disturbances of cognitive function. [...]when investigating the brain effects of ketamine in humans, investigators focus on regions of interest that are believed to be relevant to psychosis in schizophrenia. Some recent studies following areas of increased functional magnetic resonance imagine (fMRI) blood oxygen level dependent (BOLD) signal after ketamine have taken a more agnostic approach of simply looking at the areas that show the largest and/or most reproducible increases in healthy volunteers.6 The purpose of these studies is to use blockade of any ketamine signal as evidence of drug action in the brain with clinical doses of both risperidone and lamotrigine. An additional strategy is to relate the molecular actions of ketamine to effects on brain circuits in animals as a basis for identifying mechanisms that might generate analogous circuit effects to those that can be evaluated in humans.8 Preclinical studies in rodents have begun to look at regional and temporal dynamics of cellular and molecular events triggered by ketamine to enhance synaptic plasticity in the prefrontal cortex and hippocampus.8 The availability of tools to selectively modulate the signaling molecules that are implicated in ketamine's rapid antidepressant effects (eg, neurotropic factors, mTOR, eEF2 kinase, GSK-3β) will enable one to establish a link between the molecular signatures and behavioral effects.