eTARGET

eTARGET is a digital solution to provide decision science support for the TARGET (Tumour chARacterisation to Guide Experimental Targeted therapy) trial molecular tumour board. Now an integral part of the MTB’s decision-making process, eTARGET has transformed the data visualisation and interpretation by integrating genomic and clinical data in a single portal and capturing decisions in real-time. Decisions regarding significant variants, trial matching and requirements for further analyses are all held in eTARGET.

This successful partnership brought together the digital ECMT, the TARGET trial clinicians, CRUK scientists and a University of Manchester software engineer. Key considerations for the development of eTARGET were automating data extraction from disparate sources in different organisations and developing a secure cloud infrastructure. Further benefits are that patient data can be viewed remotely, making  a virtual MTB possible.

Through eTARGET, a genomic dataset has now been established and can be utilised as a research tool to interrogate the TARGET data.

“eTARGET is a perfect example of why  the work of the digital ECMT is so important and how they  contribute to the holistic goals of the biomarker centre” – Caroline Dive, Deputy and Senior Group Leader, Cancer Research UK Manchester Institute; Director, Manchester Centre for Cancer Biomarker Sciences

REACT – REal time Analytics for Clinical Trials

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). Adaptive changes are often needed regarding the dose, schedule, patient population, the combination of drugs 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 decision-making.

We explore new ways to conduct and interpret clinical trials. Our research platform facilitates research into new data-models, tools and techniques to collect, curate, analyse, interpret and visualise data. REACT, our advanced analytics system enables:

  • fast, intuitive and powerful drill-down from all data points across the clinical trial
  • an integrated view of all data, over time for an individual, selected patient
  • flexible exploration of clinical data – safety, laboratory measurements, efficacy, pharmacokinetics and genomics
  • near real-time decision making and hypothesis generation
  • integration of genomic and clinical data in real-time and a greater understanding of gene signatures associated with response

“While it used to take me a day to prepare data for discussion at a meeting, now it takes an hour. REACT enables us to focus on interpreting the findings. It makes time for science!” Sponsor

The digital ECMT brought together clinicians, technology and genomic experts. We are now able to create a link between our REACT Genomic Profile and CBioPortal (open source tool for genomic analysis) to perform more in-depth analysis for patients of interest.   An additional enhancement is the ability to track genetic changes in the tumour over time using ct DNA (circulating tumour DNA) visualisations, which could contribute to the earlier detection of disease progression for some patients.

“The integration of genomic and clinical data has significantly improved the ability to interpret responder populations in an ongoing clinical trial and the delivery of platform trials”  Clinical Director

PROACT

PROACT (Patient Reported Outcomes About Clinical Tolerability) is a system that gives patients and caregivers a way to compliantly share their experiences on trial with their research team. Participants have control over what they want to share in video, audio, or text messages, and when they would like to share them. This PROACT trial aimed to understand the implications of setting up and using the PROACT system in multiple early phase studies, at multiple sites. It also aimed to characterise how patients used the system, and to also understand whether it is practical to give PROACT accounts to primary caregivers.

Research nurses played a key role in responding to messages and arranging care. In addition, nurses identified several benefits, most of which related to providing timely support as well as signposting to external guidance when needed. Clinical trial participants shared a wide range of experiences, from tolerability, information about the drug or schedule, benefits of the drug, logistics, or to simply say ‘thank you’. All of these delivered a rich understanding of patient and carer perspectives, context around the reported data, impacts that the drug and trial were having, and coping strategies that were being used. Critically, this approach was also an efficient method for capturing the emotional status of participants through their own words and also selection of emoticons.

In conclusion, use of communications systems such as PROACT can provide researchers with an early glimpse into patient and carer experiences that could affect adherence and decisions around compliance in the future. As virtual trials become a reality, and participants have less face-to-face interaction with their medical team, these early insights are likely to become increasingly important. A researcher being able to hear directly from trial participants about which factors of a study and drug are burdensome, coping strategies, and what is driving emotional decisions, may make an essential difference in the quest to develop medicines that work both clinically, and for the people they’re intended to treat.

“PROACT allows patients to keep in touch with their study team in between their visits to clinic. This gives us updates on how patients are coping with any side effects and we are able to provide them with better support” – ECMT Clinical Research Nurse

Watch the video below to hear from the Research Nurses at