Neal R. Cutler

Establishing a clinical trial site: A primer for aspiring principal investigators

John J. Sramek, Manuel Carrillo, Neal R. Cutler

Establishing a private clinical trial site is an increasingly appealing but complex opportunity for physicians interested in becoming Principal Investigators (PIs) in FDA-regulated research. This article provides a comprehensive overview for aspiring PIs, detailing the critical requirements and best practices for launching …

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The Role of the Contract Research Organization in Alzheimer’s Disease: The Vital Link in the Clinical Drug-Development Program

John J. Sramek, Henry Riordan, Michael F Murphy, Neal R. Cutler

This chapter reviews the critical role that a contract research organization performs in developing new therapeutics for Alzheimer’s disease (AD). Late-phase AD trials are lengthy, expensive, and require specialized expertise and experience in order to optimize signal detection. We review the intricacies …

Phase 1 Clinical Trials of Small Molecules: Evolution and State of the Art

John J. Sramek, Michael F Murphy, Sherilyn Adcock, Jeffrey G. Stark et autres

BACKGROUND: Phase 1 studies comprise the first exposure of a promising new chemical entity in healthy volunteers or, when appropriate, in patients. To assure a solid foundation for subsequent drug development, this first step must carefully assess the safety and tolerance of …

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P1‐335: AN EVALUATION OF INDEPENDENT SUBJECT ELIGIBILITY REVIEWS TO ENSURE ENROLLMENT OF HIGH QUALITY APPROPRIATE SUBJECTS IN MILD ALZHEIMER'S DISEASE (AD) TRIALS

Melissa A. Carbo, Colleen Rock, Kelly J. Doyle, Rolana Avrumson et autres

The enrollment of appropriate subjects with mild AD is crucial to ensure valid and reliable data in clinical trials. It is essential to follow a refined set of diagnostic criteria to accurately represent the targeted population. The enrollment of ineligible subjects can …

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Lurasidone in post-menopausal females with major depressive disorder with mixed features: Post-hoc analysis of a placebo-controlled trial

John J. Sramek, Antony D Loebel, Michael F Murphy, Yongcai Mao et autres

BACKGROUND: Several studies have found that depressed, post-menopausal females may respond differently to antidepressants compared to pre-menopausal females. The atypical antipsychotic lurasidone, whose mechanism of action differs from SSRIs and other standard antidepressants, was shown in a 6-week randomized, flexible-dose, placebo-controlled study …

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680. Lurasidone in Post-Menopausal Females with Major Depressive Disorder with Mixed Features: Post-Hoc Analysis of a Placebo-Controlled Trial

John J. Sramek, Anthony Loebel, Michael F Murphy, Yongcai Mao et autres

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Sex differences in the psychopharmacological treatment of depression

John J. Sramek, Michael F Murphy, Neal R. Cutler

Although a number of studies have observed that females respond better to serotonergic antidepressants than males and that postmenopausal females have a diminished response to antidepressants compared with younger females, there are also studies that conflict with both of these findings, making …

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State-of-the-Art Pharmacy Services

Sherilyn Adcock, Jeremy David Kuhn, Andrea Hamilton, George J. Atiee et autres

Phase I clinical studies form an important foundation for drug development and the eventual approval of life-saving therapies. The authors review an ideal suite of state-of-the-art pharmacy services in a Phase I clinical research unit that is tailored to the operations of …

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Exploratory Biomarker Study of the Triple Reuptake Inhibitor SEP‐432 Compared to the Dual Reuptake Inhibitor Duloxetine in Healthy Normal Subjects

John J. Sramek, Larry W. Hardy, P. R. Bieck, Cynthia A. Zamora et autres

INTRODUCTION: SEP-432 is a triple monoamine reuptake inhibitor of norepinephrine (NE), serotonin (5-HT), and dopamine (DA), based on in vitro binding studies. We sought evidence that SEP-432 engages these monoamine systems by measuring concentrations of monoamines and/or their main metabolites in cerebrospinal …

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Bivariate evaluation of thromboembolism and bleeding in clinical trials of anticoagulants in patients with atrial fibrillation

Philippe Gabríel Steg, Jonathan L. Halperin, Neil A. Goldenberg, Sam Schulman et autres

Clinical trials of antithrombotic therapy require a cohesive assessment of benefit and risk. A new graphical method to represent the bivariate relation of benefit and risk in trials of antithrombotic drugs is described and illustrated using published data from the four major …

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Pleocytosis in cerebrospinal fluid following multiple lumbar punctures in healthy volunteers

George J. Atiee, John J. Sramek, Joseph Palasota, Sarah Andrews et autres

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Pleocytosis in cerebrospinal fluid following multiple lumbar punctures in healthy volunteers

George J. Atiee, John J. Sramek, Joseph Palasota, Michael F Murphy et autres