PHASTAR's life science day at Alderley Park

PHASTAR to host life science day at Alderley Park

Fresh from the success of their Boston-Cambridge Life Science evening, the PHASTAR team is at it again! This time PHASTAR will be hosting a Life Science Day near it's Alderley Park offices in Cheshire, UK.

The day will explore the theme of 'how statistical analysis and data science can enhance drug and diagnostic device development' and will feature talks given by PHASTAR staff and external experts.

Featuring talks from:

'What is Health Data Science? One biostatistician’s answer' by Professor Peter Diggle, Distinguished University Professor at CHICAS, Lancaster University Medical School.

'What sample size? 101 other ways statisticians influence trial design' by Andrew Lloyd, Head of Statistics - PHASTAR.

'Extracting value from real-world data: an example with wearables' by Professor Jennifer Bradford, Head of Data Science - PHASTAR.

'You've developed your AI tool - now how do we test it?' by Professor Jennifer Rogers, Head of Statistical Research - PHASTAR.

'Ensuring sponsor oversight, and quality of data and interpretation for early phase trials' by Dr Susan Lovick, Statistical Technical Lead - PHASTAR.

The event will take place on Tuesday 26th November, 9:30am-4pm at the Alderley Park Conference Centre. Registration will start at 9:30am and the sessions will run from 10am-4pm, followed by a networking reception at 4pm-6pm.

If you are interested in attending sign up is free and can be found here

Data Management of adaptive trial designs

Adaptive Trial Design

Traditionally, studies have been run with a process of study design, study conduct, study report. Whilst this is more straight-forward it is not flexible and does not allow for modifications or changes that may be desirable during the course of a trial. An adaptive design allows for the flexibility of interim reviews of the data, followed by pre-specified changes to the trial based on the review whilst maintaining the integrity of the trial, interim reviews may also result in outcomes such as a sample size re-estimation  These prior planned adaptations are different to ad hoc protocol amendments, as the adaptations are already allowed for in the protocol.

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Data Science: making sense of data

Data Science: making sense of data

The volume of digital data in healthcare is projected to increase more rapidly in the coming years than any other sector. On a day-to-day basis it is vital that clinical teams ensure they are maximising the value, not only of their own trial data but also of the wealth of external data for example electronic healthcare records, real-world data and peer-reviewed research published in journals.

The ability to utilise this data requires not only an understanding of what is available but how to access the data, work with the structure of the data, understand the quality and inherent biases and importantly apply the right methodology to extract value. In addition to the large volume of standard data generated on a clinical trial there can be a raft of other, more specialised data, such as genomics, proteomics, wearables and comprehensive measurements all of which rely on the skills of an experienced data management, programming and statistics team to utilise.

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PHASTAR's PhUSE EU posters and presentations!

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The opportunities and challenges of basket studies

There has been a growing emergence in the utilisation of basket studies and it’s not difficult to see why. Progress in genomics, tumour biology and statistics has led to advances in “precision oncology”. Cancers that were once viewed as homogeneous in terms of location and treatment strategy are now better understood to be increasingly heterogeneous across biomarkers and genetically determined subgroups. No two cancers are the same; tumours differ from patient to patient and few patients may noticeably improve with treatment, whilst others experience no benefit at all. As a result, we have seen a shift towards targeted agents, and it has become more common for trials to focus on a specific mutation at a particular location.

When thinking about the timeframe from initial drug discovery to regulatory review, we need to embrace novel clinical trial designs that improve efficiency. With this in mind, there has been an observable trend towards investigating multiple target-treatment pairs in parallel, either within, or across tumour types. The term “master protocol” refers to a general framework whereby multiple parallel drug studies are operated under one overarching protocol. A basket trial is a type of master protocol that tests the effect of one drug on a single mutation in a variety of tumour types. That is, they include patients with a certain genetic mutation in common regardless of the site or origin of cancer in the body, so patients have cancer at a variety of sites such as lung, breast, prostate, etc.

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