Determination of quality of life-related health utilities for surgical complications in ovarian cancer.

Objective: To assess the health state utilities of ovarian cancer patients, clinicians, and non-cancer controls regarding surgical complications in ovarian cancer.

Methods: Utilities for 14 surgical complications were assessed from patients with recently diagnosed or recurrent ovarian cancer, clinicians, and non-cancer controls using the visual analog scale (VAS) and time trade-off (TTO) methods. Health state utilities were converted to a 0-to-1 scale, where 0 represents the least favorable outcome and 1 represents the most favorable outcome.

An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox.

Immunogenicity can impact PK, PD, efficacy and safety of biopharmaceuticals, and is often evaluated as a secondary objective in clinical studies. Methods to detect anti-drug antibodies (ADA) and neutralizing ADA (NAb) are semi-quantitative and utilize cut points to determine positive or negative samples. Assay cut points are established by the statistical analysis of treatment-naïve subject specimens that are assumed ADA and NAb-negative.

Multiplexing of receptor occupancy measurements for pharmacodynamic biomarker assessment of biopharmaceuticals.

Background: Receptor occupancy (RO) assays measure drug target engagement, and are used as pharmacodynamic (PD) biomarkers. RO assays are commonly performed by flow cytometry and often require multiplexing for assessment of multiple PD biomarkers when specimen volumes are limited. We present multiplexed RO assays for an IGF1R-EGFR bispecific antibody (Bs-Ab) and a CTLA4-Ig recombinant fusion protein to demonstrate key considerations for accurate RO assessment.

Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development.

Receptor occupancy (RO) assays are designed to quantify the binding of therapeutics to their targets on the cell surface and are frequently used to generate pharmacodynamic (PD) biomarker data in nonclinical and clinical studies of biopharmaceuticals. When combined with the pharmacokinetic (PK) profile, RO data can establish PKPD relationships, which are crucial for informing dose decisions. RO is commonly measured by flow cytometry on fresh blood specimens and is subject to numerous technical and logistical challenges.

Public perceptions and preferences for patient notification after an unsafe injection.

Background: Unsafe injection practices in health-care settings often result in notification of potentially affected patients, to disclose the error and recommend blood-borne pathogens testing. Few studies have assessed public perceptions and preferences for patient notification.

Methods: Six focus groups were conducted during Fall 2009, with residents of Atlanta, GA, and New York City, NY.

A qualitative assessment of a performance measure for reporting influenza vaccination rates among healthcare personnel.

To understand the feasibility of implementing a standardized performance measure for collecting and reporting influenza vaccination rates among healthcare personnel, qualitative, semistructured interviews were conducted with key informants in 32 healthcare facilities. Despite practical and logistical challenges to implementing the measure, respondents perceived clear benefits to its use.