Core Concepts in Pharmacoepidemiology: Time-To-Event Analysis Approaches in Pharmacoepidemiology.

Aim: This article provides an overview of time-to-event (TTE) analysis in pharmacoepidemiology.

Materials & Methods: The key concept of censoring is reviewed, including right-, left-, interval- and informative censoring. Simple descriptive statistics are explained, including the nonparametric estimation of the TTE distribution as per Kaplan-Meier method, as well as more complex TTE regression approaches, including the parametric Accelerated Failure Time (AFT) model and the semi-parametric Cox Proportional Hazards and Restricted Mean Survival Time (RMST) models.

Investigating the trends in patient-reported outcomes pre-treatment and implications to efficacy analyses: A post-hoc analysis of a cancer clinical trial.

Background: Uncertainty around key elements of an appropriate patient-reported outcome (PRO) baseline assessment introduces trial-specific variation in oncology clinical trials with a poorly understood consequence on drug evaluation decisions. This research investigated the impact of multiple pre-treatment PRO assessments and timing of assessments in a clinical trial.

Methods: A post-hoc analysis of a completed phase 3, open-label, randomized, parallel arm clinical trial in non-small cell lung cancer with two pre-treatment PRO assessments (screening and Week 1 Day 1 [W1D1]).

A Review of Causal Inference for External Comparator Arm Studies.

Randomized controlled trials (RCTs) are the gold standard design to establish the efficacy of new drugs and to support regulatory decision making. However, a marked increase in the submission of single-arm trials (SATs) has been observed in recent years, especially in the field of oncology due to the trend towards precision medicine contributing to the rise of new therapeutic interventions for rare diseases. SATs lack results for control patients, and information from external sources can be compiled to provide context for better interpretability of study results.

Strong off-target antibody reactivity to malarial antigens induced by RTS,S/AS01E vaccination is associated with protection.

The RTS,S/AS01E vaccine targets the circumsporozoite protein (CSP) of the Plasmodium falciparum (P. falciparum) parasite. Protein microarrays were used to measure levels of IgG against 1000 P.