REACT (REal-time Analytics for Clinical Trials): supporting decision-making for early cancer trials


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Fouziah Butt1,Dónal Landers1,Paul Fitzpatrick1,Julie Stevenson1,Laura Stephenson1,Richard Hoskins2
1Cancer Research UK, Manchester Institute - digital Experimental Cancer Medicine Team,2The University of Manchester, Research IT

Abstract

Background

Phase 1, first-in-human clinical trials are amongst the most complex and challenging during drug development and involve the organisation, gathering and interpretation of large amounts of data (~10,000 data points per patient).  Moreover, adaptive changes to these trials are often needed; for example, to the dose, schedule, patient population, drug combination and the deployment of potential predictive biomarkers.  This drives the need for near real-time access to emerging trial data to support timely and effective decisions.

Method

REACT is a digital science platform providing clinical trial teams and investigators with an integrated, intuitive suite of visualisations which support multiple domains of clinical data including efficacy, safety and tolerability. 

Results

REACT has the potential to enable the sponsor to detect signals in the data and understand the benefit-risk profile for new cancer treatments earlier compared with the standard programmed output approach.  It also avoids the need for manual extraction and visualisation of data. 

REACT, originally developed alongside clinicians at AstraZeneca, has been delivered to other sponsors and investigators by the digital Experimental Cancer Medicine Team (ECMT).  More recently the digital ECMT have further enhanced REACT by integrating clinical and genomic data, which has enabled investigation of genetic alterations across the patient population in a genomic profile visualisation and tracking of genetic changes in the tumour using bespoke circulating tumour DNA visualisations. 

Furthermore, REACT has been linked to cBioPortal, an open source tool which enables in-depth genomic analysis for patients of interest.

Conclusion

REACT enables near real-time access to the trial data to those involved in ongoing early clinical trials, both from the sponsor organisation and care-giving site thus allowing focus on earlier data interpretation and decision-making rather than data gathering.  REACT supports both the individual patient management by the caregiver and drug development decisions made by the trial sponsor.