More than just a Subgroup – Applications of Personalised Medicine in Clinical Trial Design

One standard request in larger clinical trials is to assess whether the observed treatment effect in the primary endpoint is consistent across subgroups.  Analyses on subgroups is a widely discussed topic: searching the internet for “subgroup analysis in clinical trials” gives over 700,000 results. The discussion in the majority of these articles revolves around potential pitfalls of subgroup analysis. The idea of subgroup analyses is to test for homogeneity similarity or heterogeneity across the subgroups.

However, there is another type of “subgroup analysis” - where the interest lies in targeting certain patient populations that would benefit from a particular treatment. This is one goal of precision medicine; to effectively screen patients to ensure they are given the most appropriate treatment, based on genetic data (for example, pre-screening patients to identify those that are “biomarker positive” prior to treatment, or to enrol them onto a clinical trial).

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Introduction to Precision Medicine

Precision Medicine

Although the first published results relating genetics to treatment outcomes was in 1902, we are still learning so much about the field of "precision medicine" that there is ongoing debate about its definition and name (e.g. personalised/stratified/P4 - Predictive, Preventive, Personalized and Participatory). The basic premise is that the relationship between how a patient responds to a treatment can be better explained by taking into account data on the patients' molecular profile, environment and lifestyle. Traditional assessment of treatments using randomized clinical trials have generally assumed that there is an average effect across all the patients allocated to that treatment in a trial, a "one size fits all" approach. Of course, we are all unique, and there is no doubt that our health is determined by genetics as well as lifestyle and environmental factors.

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BioTrinity 2018 in London

PHASTAR attending BioTrinity 2018 in London

PHASTAR will be attending the BioTrinity conference for the first time which is taking place from 23-25 April in London. We are looking forward to meeting with companies that have need for statistical consulting, data analysis and data collection for clinical studies.

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PSI Medical Statistics Taster Day at Leicester University

Meet PHASTAR at PSI Medical Statistics Taster Day 2018

PHASTAR will be attending the PSI Medical Statistics Taster Day on 28th February at the University of Leicester. It is promising to be an informative event for those who are interested in a career in medical statistics.

PHASTAR will have an exhibition stand at Stamford Court so come and say hello if you’d like to know what a career at PHASTAR could offer you.

From 6pm we will be also be providing food and drinks at the Indian restaurant Shimla Pinks for those who may be interested in working for us.

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