PHASTAR Life Science Summit

A global statistics and data science forum

PHASTAR was delighted to host the 2020 PHASTAR Life Science Summit – a global statistics and data science forum.

Running over two afternoons on Tuesday 30th June and Wednesday 1st July, PHASTAR’s Life Science Summit focused on developing and delivering statistical and data science excellence with engaging discussions and presentations from industry experts. PHASTAR’s Life Science summit covered timely topics such as COVID-19, statistics in clinical trials, data science and its applications, as well as a dedicated young statisticians’ showcase.

A number of presentations from the summit have been made available below:

Plenary sessions:

Abstract: Statistical Validation of Biomarkers for Use in Early Clinical Development and Biotechnology

Clinical trials are the golden standard when evaluating the potential of a novel treatment, a standard that should not be compromised during a pandemic. At the same time, there are unique challenges in conducting studies in a novel disease, such as COVID-19, and developing novel treatments during a major outbreak of the disease. 

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Abstract: 'Sequential Bayesian Designs for Rapid Learning in COVID-19 Clinical Trials' By Prof. Frank Harrell

Abstract: 'Inference from an Ongoing Clinical Trial Affected by COVID-19 to the Post-COVID-19' By Dr. Janet Wittes

Abstract: 'Clinical trials: Quo Vadis in the Age of COVID-19' By Prof. Stephen Senn

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Statistics in clinical trials:

Abstract: Statistical Validation of Biomarkers for Use in Early Clinical Development and Biotechnology

Despite the fact that a large number of candidate biomarkers have been identified by biologists during the last decades, very few of these has made it all the way to clinical practice. One of the reason for this, is lack of proper validation on a level that is satisfactory to the authorities and the medical community. Biomarker validation, viewed as...

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Abstract: Recurrent Events Analysis in the Presence of Dependent Censoring: the Joint Frailty Model

Many chronic diseases are characterised by non-fatal recurrent events. Examples of such include asthma attacks in asthma, epileptic seizures in epilepsy and hospitalisations for worsening condition in heart failure. Analysing all these repeat events within individuals is more representative of disease progression and more accurately estimates...

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Abstract: Greenwood's survival variance estimator revisited

Bayesian approaches to adaptive clinical trial design have attractive properties and there is broad desire to apply them in clinical practice. Adoption of these methods may be limited because there is often a gulf between their theoretical benefits and the tools and understanding that are required to implement them effectively. We will discuss a few cases of implementing Bayesian methods in early phase oncology trials supported by PHASTAR, and investigate some software resources that are available...

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Abstract: Practical Implementation of Bayesian Approaches to Adaptive Trial Design

Bayesian approaches to adaptive clinical trial design have attractive properties and there is broad desire to apply them in clinical practice. Adoption of these methods may be limited because there is often a gulf between their theoretical benefits and the tools and understanding that are required to implement them effectively. We will discuss a few...

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Abstract: Collaborative Platform Trials to Fight COVID-19: methodological and regulatory considerations for a better societal outcome

In the current pandemic drug developers are facing a challenging situation where, while speed is of the essence, quality of the evidence remains of primary importance. After the first reports of COVID-19 spreading to numerous countries a rush to initiate clinical trials has been observed. Many of these trials have been designed in isolation and are...

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Abstract: Data Handling and Reporting for Ongoing Clinical Trials During COVID-19

The COVID-19 outbreak has significantly impacted the clinical research industry. Analysis conducted on data obtained from www.clinicaltrials. gov on March 31, 2020, identified more than 9,250 industry-funded clinical trials that could be impacted. Regulatory agencies in the EU, US, and elsewhere have published guidance on how clinical...

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Abstract: 'Ordinal endpoints in clinical trials. An exploration into their construction and interpretation with recent examples from RCTs in severe influenza and COVID-19'.

Ordinal endpoints are often meaningful endpoints as they represent the ordered, exhaustive set of mutually-exclusive clinical states for a particular disease or condition. Despite advantageous statistical properties, ordinal endpoints are less common in clinical trials compared to endpoints measured on a continuous or dichotomous...

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Abstract: 'Simultaneous visualisation of a time-to-event outcome and multivariate mixed ­type covariate data'.

The ever-increasing complexity and dimensionality of clinical data sets means that the role of effective data visualisations to understand and interpret clinical data is more important than ever. Biplots are a multivariate generalisation of scatter plots that can be used to visualise the key features of clinical data sets in a low-dimensional space....

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