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ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices): The evolution of a collaborative regional CTSA-funded forum and website for regulatory support

September 13, 2021
This paper describes the development and deployment of 1) a regional forum of regulatory professionals (ReGARDD) from Clinical and Translational Science Award (CTSA)-funded institutions designed to build and capitalize on local expertise and 2) a regulatory guidance website (ReGARDD.org) geared toward academic researchers that reached 6000+ users in 2019 and...

Inhibitory gating of coincidence-dependent sensory binding in secondary auditory cortex

September 13, 2021
In our daily life, even in the face of multiple sound sources, our brain binds together frequency components that belong to the same source and recognizes individual sound objects, such as our conversations. We found that a higher-order auditory cortex, the A2 area, plays a critical role in this sound...

Informed consent: Old and new challenges in the context of the COVID-19 pandemic

September 13, 2021
Through the lens of the experiences of and challenges for Clinical and Translation Science Award (CTSA) institutions, this paper addresses how COVID-19 has impacted informed consent for clinical research, including an overview of informed consent and the challenges that existed prior to COVID-19, modifications to informed consent processes in response...

Enhancing stress reactivity and wellbeing in early schizophrenia: A randomized controlled trial of Integrated Coping Awareness Therapy (I-CAT)

September 13, 2021

Discriminatory experiences predict neuroanatomical changes and anxiety among healthy individuals and those at clinical high risk for psychosis

September 13, 2021
Individuals face discrimination and discriminatory experiences (DE) based on characteristics including race/ethnicity, gender, age, and disability. This report assessed whether lifetime DE are associated with changes in brain structure (e.g. cortical thinning) and clinical outcomes across time. This report provides the first evidence to date of an association between DE...

A Clinical Brexanolone Treatment Program at an Academic Medical Center- challenges and lessons learned with patient selection and post 30 day outcomes

September 13, 2021
Brexanolone (Zulresso) is the first Federal Drug Administration (FDA) approved drug for the treatment of postpartum depression (PPD). Brexanolone is a positive allosteric modulator of the GABAA receptor, and is given over 60 hours by infusion in a medical setting. This drug has been shown to be effective at significantly reducing...