Academic medical center clinical research professional workforce: Part 2 - Issues in staff onboarding and professional development.

Background: Defining key barriers to the development of a well-trained clinical research professional (CRP) workforce is an essential first step in identifying solutions for successful CRP onboarding, training, and competency development, which will enhance quality across the clinical and translational research enterprise. This study aimed to summarize barriers and best practices at academic medical centers related to effective CRP onboarding, training, professional development, identify challenges with the assessment of and mentoring for CRP competency growth, and describe opportunities to improve training and professionalization for the CRP career pathway.

Materials/methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore the complex issues involved when developing high-quality onboarding and continuing education opportunities for CRPs at academic medical centers.

Clinical Investigator Training Program (CITP) - A practical and pragmatic approach to conveying clinical investigator competencies and training to busy clinicians.

Introduction: Clinical investigation is a critical component of clinical medicine. Yet, other than mentorship by an experienced senior physician, young physicians have few formal training opportunities that fit into their clinical training and convey the pre-requisite clinical investigator competencies. To address this training gap, we designed the Clinical Investigator Training Program (CITP); a practical and pragmatic curriculum weaved into the constant pressures of balancing patient care with academic pursuit required of the academic practitioner.

Creating and testing a GCP game in an asynchronous course environment: The game and future plans.

Introduction: The National Institute of Health has mandated good clinical practice (GCP) training for all clinical research investigators and professionals. We developed a GCP game using the Kaizen-Education platform. The GCP Kaizen game was designed to help clinical research professionals immerse themselves into applying International Conference on Harmonization GCP (R2) guidelines in the clinical research setting through case-based questions.

Lack of Efficacy of High-Titered Immunoglobulin in Patients with West Nile Virus Central Nervous System Disease.

West Nile Virus (WNV) can result in clinically severe neurologic disease. There is no treatment for WNV infection, but administration of anti-WNV polyclonal human antibody has demonstrated efficacy in animal models. We compared Omr-IgG-am, an immunoglobulin product with high titers of anti-WNV antibody, with intravenous immunoglobulin (IVIG) and normal saline to assess safety and efficacy in patients with WNV neuroinvasive disease as part of a phase I/II, randomized, double-blind, multicenter study in North America.

Blood Viral Load in Symptomatic Congenital Cytomegalovirus Infection.

Background: Viral loads (VLs) frequently are followed during treatment of symptomatic congenital cytomegalovirus disease, but their predictive value is unclear.

Methods: Post hoc analysis of 2 antiviral studies was performed. Seventy-three subjects were treated for 6 weeks and 47 subjects were treated for 6 months.

A Randomized, Double-Blind, Placebo-Controlled Trial of Pleconaril for the Treatment of Neonates With Enterovirus Sepsis.

Background: Neonatal enterovirus sepsis has high mortality. Antiviral therapy is not available.

Methods: Neonates with suspected enterovirus sepsis (hepatitis, coagulopathy, and/or myocarditis) with onset at ≤15 days of life were randomized 2:1 to receive oral pleconaril or placebo for 7 days.

Herpes Simplex Encephalitis: Lack of Clinical Benefit of Long-term Valacyclovir Therapy.

Background: Despite the proven efficacy of acyclovir (ACV) therapy, herpes simplex encephalitis (HSE) continues to cause substantial morbidity and mortality. Among patients with HSE treated with ACV, the mortality rate is approximately 14%-19%. Among survivors, 45%-60% have neuropsychological sequelae at 1 year.

Enhancing research capacity for global health: evaluation of a distance-based program for international study coordinators.

Introduction: Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This article describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the United States.

Methods: A total of 692 applications were received from CRMs in 50 countries.

Oseltamivir pharmacokinetics, dosing, and resistance among children aged <2 years with influenza.

Background: Children <2 years of age are at high risk of influenza-related mortality and morbidity. However, the appropriate dose of oseltamivir for children <2 years of age is unknown.

Methods: The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group evaluated oseltamivir in infants aged <2 years in an age-de-escalation, adaptive design with a targeted systemic exposure.

Oral acyclovir suppression and neurodevelopment after neonatal herpes.

Background: Poor neurodevelopmental outcomes and recurrences of cutaneous lesions remain unacceptably frequent among survivors of neonatal herpes simplex virus (HSV) disease.

Methods: We enrolled neonates with HSV disease in two parallel, identical, double-blind, placebo-controlled studies. Neonates with central nervous system (CNS) involvement were enrolled in one study, and neonates with skin, eye, and mouth involvement only were enrolled in the other.

Oseltamivir dosing for influenza infection in premature neonates.

Under the Emergency Use Authorization issued in April 2009, oseltamivir can be used to treat 2009 influenza A (H1N1) virus infection in children aged <1 year. No data exist on the dosing of oseltamivir in premature babies. A hospital health care worker inadvertently exposed 32 neonatal intensive care unit babies to 2009 influenza A (H1N1); a protocol was expeditiously implemented to collect samples for pharmacokinetics and dosage evaluation.

Targeted antiviral prophylaxis with oseltamivir in a summer camp setting.

Objective: To describe the effectiveness of containment of novel influenza A(H1N1) infection at a summer camp.

Design: Targeted use of oseltamivir phosphate by individuals in close contact with influenza-confirmed cases.

Setting: Boys' camp in Alabama in July 2009.

Regulatory challenges: lessons from recent West Nile virus trials in the United States.

Delays in research on emerging infections could deprive the public of appropriate therapies. This report describes challenges encountered in implementing two multicenter protocols of West Nile virus (WNV) infections in the United States during 2003. Protocol development times, federal regulatory approvals, and local Institutional Review Boards (IRB) approvals were compiled.