Follow-up of SARS-CoV-2 positive subgroup from the Asymptomatic novel CORonavirus iNFection study.

A nested longitudinal study within theAsymptomatic novel CORonavirus iNFfection study followed participants with positive nasopharyngeal swab to query for development of symptoms and assess duration of positive reverse transcription-polymerase chain reaction (RT-PCR) test results. Of the 91 participants initially testing positive, 86 participated in follow-up approximately 14 days after study enrollment; of those 86 participants, 19 (22.1%) developed at least one symptom at any time after the initial positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test result.

A cross-sectional community-based observational study of asymptomatic SARS-CoV-2 prevalence in the greater Indianapolis area.

The Asymptomatic novel CORonavirus iNfection (ACORN) study was designed to investigate the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the asymptomatic adult population of the Indianapolis metropolitan area, to follow individuals testing positive for the development of symptoms, and to understand duration of positive test results. ACORN is a cross-sectional community-based observational study of adult residents presenting asymptomatic for COVID-like illness, defined as the self-reported absence of the following three symptoms in the last 7 days: fever (≥100°F), new-onset or worsening cough, and new-onset or worsening shortness of breath. SARS-CoV-2 infection was determined by real-time reverse transcription-polymerase chain reaction in nasopharyngeal swab samples.

Restricted mean survival time for the analysis of cardiovascular outcome trials assessing non-inferiority: Case studies from antihyperglycemic drug development.

Cardiovascular outcome trials (CVOTs) have been employed in multiple therapeutic areas to explore whether a noncardiovascular drug increases the risk for cardiovascular events. These studies are now a central part of drug development programs for antihyperglycemic drugs. These programs are expected to demonstrate that new antihyperglycemic drugs for patients with Type 2 diabetes do not have unacceptable cardiovascular risk.

Perspectives on Some Controversies in Cardiovascular Disease Risk Assessment in the Pharmaceutical Development of Glucose-Lowering Medications.

The U.S. Food and Drug Administration (FDA) issued guidance on requirements to assess cardiovascular disease (CVD) risk with drugs being developed for approval for clinical use.

A clinical utility index for selecting an optimal insulin dosing algorithm for LY2605541 in patients with type 2 diabetes pretreated with basal insulin.

Background: Because insulin dosing requires optimization of glycemic control, it is important to use a single metric of benefit and risk to determine best insulin dosing practices. We retrospectively applied a multiplicative clinical utility index (CUI) to a study of LY2605541 (Eli Lilly and Company, Indianapolis, IN), a novel, long-acting basal insulin.

Materials And Methods: A CUI was developed to transform the multidimensional problem of assessing benefit/risk of multiple dosing algorithms into a single decision-making metric to evaluate two LY2605541 dosing algorithms relative to the insulin glargine (GL) dosing algorithm.

Bayesian methods for design and analysis of safety trials.

Safety assessment is essential throughout medical product development. There has been increased awareness of the importance of safety trials recently, in part due to recent US Food and Drug Administration guidance related to thorough assessment of cardiovascular risk in the treatment of type 2 diabetes. Bayesian methods provide great promise for improving the conduct of safety trials.

Optimizing Drug Development Programs: Type 2 Diabetes Case Study.

Recently, consideration was given to the impact of dose selection strategies in phase IIb on the overall success of drug development programs. A natural next step is to simultaneously optimize design aspects of both phase IIB and phase III. We used type 2 diabetes as an example, including realistic regulatory and commercial scenarios for this indication.

Bayesian adaptive dose-finding studies with delayed responses.

In recent years, Bayesian response-adaptive designs have been used to improve the efficiency of learning in dose-finding studies. Many current methods for analyzing the data at the time of the interim analysis only use the data from patients who have completed the study. Therefore, data collected at intermediate time points are not used for decision making in these studies.

Upper basilar artery aneurysms: oculomotor outcomes in 163 cases.

Object: The purpose of this study was to identify factors predictive of postoperative oculomotor nerve palsy among patients who undergo surgery for distal basilar artery (BA) aneurysms. The data can be used to estimate preoperative risk in this population. The natural history of oculomotor nerve palsy in patients with good outcomes is also defined.

Vertebral artery-posteroinferior cerebellar artery aneurysms: clinical and lower cranial nerve outcomes in 52 patients.

Objective: To identify factors predictive of postoperative lower cranial nerve palsy (LCNP) among patients undergoing surgery for vertebral artery (VA)- posteroinferior cerebellar artery (PICA) aneurysms. The natural history of this LCNP is defined, and its effect on postoperative patient course is analyzed. No similar study has been described in the literature.