A Decision-Making Grid for Coenrollment in Multiple Clinical Trials.

Background: While subject coenrollment into multiple trials is desirable, thoughtful consideration is required to avoid compromising each trial's scientific integrity.

Objective: We developed a Decision-Making Grid (GRID) to help investigators determine whether a clinical trial is compatible with a second clinical trial, thus allowing coenrollment, or if it should be considered competing, prohibiting coenrollment.

Methods: The GRID evaluates 21 elements across 4 domains: Scientific Integrity, Data Interpretation, Feasibility/Burden, and Additional Considerations.

Development and Preliminary Testing of the Withdrawal Assessment Tool-Alpha 2 Agonist: An Assessment Instrument for Monitoring Iatrogenic Withdrawal Symptoms in Children Receiving an Alpha-2 Agonist.

Objectives: To develop and conduct preliminary testing of the Withdrawal Assessment Tool-Alpha 2 Agonist (WAT-A2A) to monitor dexmedetomidine and clonidine withdrawal symptoms in acutely ill children.

Design: Three-phase instrument development study. Phase 1: retrospective chart review of symptoms exhibited by children with documented dexmedetomidine withdrawal; phase 2: WAT-A2A instrument construction based on phase 1 data; and phase 3: prospective testing of the WAT-A2A in children weaning from alpha 2 agonists (A2As).

Compensatory mechanisms that maintain androgen production in mice lacking key androgen biosynthetic enzymes.

Testosterone and dihydrotestosterone (DHT) are essential for male development and fertility. In the canonical androgen production pathway, testosterone is produced in the testis by HSD17B3; however, adult male Hsd17b3 knockout (KO) mice continue to produce androgens and are fertile, indicating compensatory mechanisms exist. A second, alternate pathway produces DHT from precursors other than testosterone via 5α-reductase (SRD5A) activity.

Transgenic sensors reveal compartment-specific effects of aggregation-prone proteins on subcellular proteostasis during aging.

Loss of proteostasis is a hallmark of aging that underlies many age-related diseases. Different cell compartments experience distinctive challenges in maintaining protein quality control, but how aging regulates subcellular proteostasis remains underexplored. Here, by targeting the misfolding-prone Fluc luciferase to the cytoplasm, mitochondria, and nucleus, we established transgenic sensors to examine subcellular proteostasis in Drosophila.

Designing a Website to Support a Multisite, International Clinical Trial.

Background: Safe and reliable implementation of complex study protocols in multisite clinical trials requires that all study personnel have 24/7 access to up-to-date study materials. Study websites can serve as an electronic manual of operations (eMOO) to support trial conduct.

Objective: We describe the development, organization, and maintenance of a study website and eMOO to facilitate quick and efficient communication during conduct of a complex, multisite, international clinical trial.