Publications by authors named "F Grimson"
Article Synopsis
- A 12-week study showed that zilucoplan is effective in treating patients with generalized myasthenia gravis (gMG) who have acetylcholine receptor autoantibodies, but data beyond 12 weeks is limited.
- The study used a Bayesian model-informed analysis to predict zilucoplan's effects versus a control for up to 24 weeks, incorporating real-world and clinical trial data.
- Results showed significant improvement in the MG-ADL score for zilucoplan at 24 weeks, with a very high probability of a positive treatment effect compared to the control group.
Purpose: Use of real-world data (RWD) for external controls added to single-arm trials (SAT) is increasingly prevalent in regulatory submissions. Due to inherent differences in the data-generating mechanisms, biases can arise. This paper aims to illustrate how to use quantitative bias analysis (QBA).
View Article and Find Full Text PDFBackground: Single-arm trial (SAT) data is increasingly reviewed for drug approvals by regulators and Health Technology Assessment (HTA) bodies. Supplementary data in the form of external comparators (ECs) can be used to provide clinical context to support these drug evaluations. In this study we characterized HTAs for SAT-based submissions, the use of supplementary EC data and outcomes from HTA review.
View Article and Find Full Text PDFObjective: We aim to describe treatment patterns and overall survival (OS) among a Portuguese cohort of patients with small cell lung cancer (SCLC).
Methods: This study utilised a database held by IPO-Porto, Portugal's largest oncology hospital. Adult patients diagnosed with SCLC at IPO-Porto between January 2012 and June 2017, with follow-up to December 2017, were included.
Objectives: The objective of this study was to describe the real-world use and effectiveness of dolutegravir-based regimens (DBRs) in routine clinical practice in the United Kingdom.
Methods: Retrospective analysis was conducted using data from four National Health Service trusts using Climate-HIV, an electronic case record system. Eligible patients were aged ≥18 years with HIV-1 infection who were prescribed a DBR from December 2012 to March 2018.