Bridging blinded and unblinded analysis for ongoing safety monitoring and evaluation.

In order to better characterize the safety profile of investigational new drugs (INDs) during clinical development, more interest and attention have been paid to ongoing safety monitoring and evaluation. The 2015 US FDA IND safety reporting draft guidance compels sponsors to periodically evaluate unblinded safety data. However, maintaining the trial blind is necessary to avoid jeopardizing the validity of study findings.

Methodology to Estimate the Longitudinal Average Attributable Fraction of Guideline-recommended Medications for Death in Older Adults With Multiple Chronic Conditions.

Background: Persons with multiple chronic conditions receive multiple guideline-recommended medications to improve outcomes such as mortality. Our objective was to estimate the longitudinal average attributable fraction for 3-year survival of medications for cardiovascular conditions in persons with multiple chronic conditions and to determine whether heterogeneity occurred by age.

Methods: Medicare Current Beneficiary Survey participants (N = 8,578) with two or more chronic conditions, enrolled from 2005 to 2009 with follow-up through 2011, were analyzed.

Longitudinal average attributable fraction as a method for studying time-varying conditions and treatments on recurrent self-rated health: the case of medications in older adults with multiple chronic conditions.

Purpose: The objective is to modify the longitudinal extension of the average attributable fraction (LE-AAF) for recurrent outcomes with time-varying exposures and control for covariates.

Methods: We included Medicare Current Beneficiary Survey participants with two or more chronic conditions enrolled from 2005 to 2009 with follow-up through 2011. Nine time-varying medications indicated for nine time-varying common chronic conditions and 14 of 18 forward-selected participant characteristics were used as control variables in the generalized estimating equations step of the LE-AAF to estimate associations with the recurrent universal health outcome self-rated health (SRH).

Thymic carcinoma outcomes and prognosis: results of an international analysis.

Objectives: The objectives of this collaborative study were to characterize patients with thymic carcinoma, their treatment patterns, and association with overall survival (OS) and recurrence-free survival (RFS).

Methods: Clinical, pathologic, treatment, and follow-up information were analyzed. OS and RFS were the primary outcome measures.

Outcome of primary neuroendocrine tumors of the thymus: a joint analysis of the International Thymic Malignancy Interest Group and the European Society of Thoracic Surgeons databases.

Objective: Primary neuroendocrine tumors of the thymus (TNET) are exceedingly rare. We studied a large series of TNET identified through the International Thymic Malignancy Interest Group and the European Society of Thoracic Surgeons databases.

Methods: This was a retrospective multicenter study of patients undergoing operation for TNET between 1984 and 2012.

Matricellular protein CCN1 (CYR61) expression is associated with high-grade ductal carcinoma in situ.

Cysteine-rich protein 61, connective tissue growth factor, and nephroblastoma overexpressed gene (CCN) comprise a family of matricellular proteins that have multiple physiologic functions including development, tissue repair, cell adhesion, migration, and proliferation. The expression of CCN1, cyclin D1, β-catenin, and p53 was explored by immunohistochemistry in different grades of ductal carcinoma in situ (DCIS) cases. These cases did not contain any infiltrating carcinoma components.