Assessing Patient Risk, Benefit, and Outcomes in Drug Development: Insights From Afatinib Clinical Trials Across Diverse Cancer Indications.

Purpose: In 2013, afatinib was approved for non-small-cell lung cancer with subsequent indication expansion. We investigated published afatinib clinical trials to assess risk and benefit profiles for the drug in its approved indication of non-small-cell lung cancer as well as in off-label uses. Previous literature demonstrates excessive patient burden and limited benefit as afatinib has spread into more indications.

Understanding perceived park access and physical activity among older adults: A structural equation modeling approach.

Parks can provide a low-cost setting for safe physical activity, but older adults are underrepresented among park users in the United States. Using data from a population-representative survey in 2015 and 2018 among adults aged 60 years and older living in Philadelphia, we tested whether perceived access was a mechanism by which objectively-measured park access predicted self-reported physical activity. After controlling for individual-level factors and neighborhood characteristics, we found a statistically significant pathway from overall park area and within-park tree canopy to increased physical activity, mediated by perceived park access.

Assessing patient risk, benefit, and outcomes in drug development: A decade of ramucirumab clinical trials.

Objective: This study aims to evaluate published clinical trials of ramucirumab to assess the risk/benefit profile and burden over time for patients.

Background: The burden of oncologic drug development on patients paired with increasing clinical trial failure rates emphasizes the need for reform of drug development. Identifying and addressing patterns of excess burden can guide policy, ensure evidence-based protections for trial participants, and improve medical decision-making.

Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Lenvatinib Clinical Trials: A Systematic Review.

Importance: Chemotherapy agents are typically initially tested in their most promising indications; however, following initial US FDA approval, new clinical trials are often initiated in less promising indications where patients experience a worse burden-benefit ratio. The current literature on the burden-benefit profile of lenvatinib in non-FDA-approved indications is lacking.

Objective: This study aimed to evaluate published clinical trials of lenvatinib in order to determine the burden-benefit profile for patients over time.

Association Between Lack of Access to a Neighborhood Park and High Blood Pressure in the Philadelphia Metropolitan Area.

Introduction: Studies have shown a lower risk of high blood pressure (HBP) among people who live near parks; however, little information exists on how feeling safe and comfortable visiting the park affects blood pressure. We identified associations between neighborhood park access, comfort visiting a park, and HBP to understand how these factors may contribute to disparities in HBP prevalence.

Methods: The 2018 Southeastern Pennsylvania Household Health Survey of 3,600 residents in the Philadelphia metropolitan area asked if respondents had ever been told they had HBP and whether they had a neighborhood park or outdoor space that they were comfortable visiting during the day.