Peer-Reviewed
Publications

Open access, peer-reviewed publications ensure that knowledge is a public good. HESI believes that accessible research is critical for equitable engagement, diverse collaboration, and increased interdisciplinary conversation. We strive to achieve open access on all publications, and more than 200 publications from HESI programs have been published in the last decade.

Impact of HESI Publications
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Stakeholder Perspectives on Addressing Adverse Events from Adjuvant Cancer Therapy: A Qualitative Study

With increasing survival rates, a growing population of patients with cancer have received or will receive adjuvant therapy to prevent cancer recurrences. Patients and caregivers will confront the complexities of balancing the preventative benefits of adjuvant therapy with possible near‐term or long‐term adverse ...

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Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Adverse Drug-Induced Inotropic Effects in Early Drug Development. Part 1: General Considerations for Development of Novel Testing Platforms

Drug-induced effects on cardiac contractility can be assessed through the measurement of the maximal rate of pressure increase in the left ventricle (LVdP/dtmax) in conscious animals, and such studies are often conducted at the late stage of preclinical drug development. Detection of such effects earlier in drug research using ...

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Mode of Action (MOA) Classifications in the EnviroTox Database: Development and Implementation of a Consensus MOA Classification

Multiple modes of action (MOA) frameworks have been developed in aquatic ecotoxicology, mainly based on fish toxicity. These frameworks provide information on a key determinant of chemical toxicity, but the MOA categories and level of specificity remain unique to each of the classification schemes. This study aimed to develop a ...

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A Method for Sampling Rat Cerebrospinal Fluid with Minimal Blood Contamination: A Critical Tool for Biomarker Studies

Sampling and analysis of cerebrospinal fluid (CSF) is a common clinical practice used in the diagnosis, treatment, and prevention of neurological diseases. A similar interest is the sampling of CSF from rats to bridge the gap between bench-to-bedside work and to foster the development of new CSF biomarkers for clinical use. Here, ...

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Assessing drug-induced long QT and proarrhythmic risk using human stem cell-derived cardiomyocytes in a Ca2+ imaging assay: Evaluation of 28 CiPA compounds at three test sites

A consortium, multi-site approach to testing in vitro assay technology for prediction of drug-induced TdP. The authors sought to test calcium transient assays using the CiPA 28 drugs.

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Improving Attribution of Adverse Events in Oncology Clinical Trials

Attribution of adverse events (AEs) is critical to oncology drug development and the regulatory process. However, processes for determining the causality of AEs are often sub-optimal, unreliable, and inefficient. Thus, a toxicity-attribution workshop was conducted in Silver Spring, MD to develop guidance for improving ...

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