REACT is an interactive, visual tool for the early detection of signals and ongoing monitoring of data collected in AstraZeneca clinical trials. It is available for ongoing trials, meaning that we don’t have to wait for the trial to finish, in order to view all the data. REACT enables rapid assessment of key features such as safety, tolerability and drug exposure, at both the population and individual patient level. Specifically, REACT enables earlier:lols10
- Data-driven interpretation and science-led decisions
- Team-based data evaluation and insight to improve speed and quality of clinical development
- Comprehensive understanding of the patient benefit-risk.
This kit is digital – replacing paper-based systems. This allows rapid and iterative exploration and understanding of the data, via a web browser.
The kit shows the most recent data from the trial, meaning it is automatically up to date and the clinical scientist knows they are not missing any key 资讯rmation.
Data in REACT is linked. This allows powerful navigation from screens that display data across a patient population, right down to detailed chronological data for each patient individually.
James Weatherall James Weatherall - Head, Advanced Analytics Centre, Biometrics & Information Sciences, Global Medicines Development LOL下注网站
REACT is used by a diverse group of individuals working on ongoing trials, such as study physicians, study and project statisticians, patient safety scientists, medical scientists, regulatory experts, study operations specialists, and drug metabolism and pharmacokinetics (DMPK) scientists.
Yes. Investigators can be given access to REACT and there are many benefits to that. For example, if the Principal Investigator can access emerging data at the same time as the clinical study and translational science teams, this drives a more collaborative scientific working model with clinical and academic research organisations around the globe.
For example, due to a unique collaborative research agreement between AstraZeneca and the Christie Hospital (one of the largest cancer centres in Europe), researchers running early phase oncology trials at the Christie will also be able to access REACT.
Smart use of digital capabilities in the clinic represents the future of healthcare, and the opportunity for leading-edge interaction with data in trials. Exploring and interpreting data in ‘real time’ allows dosing decisions to be made swiftly, in the best interests of patients. It could also lead to a clinical trial being stopped in the case where there is insufficient benefit in continuing (early Go/No-Go decisions). The opportunity to gain a detailed understanding of how our new potential medicines are working, by using such technology, is very compelling for clinical scientists.
What have we achieved from having this technology?lols10
In many clinical trials, we have been able to eliminate unwieldy and time-consuming paper-based outputs which previously served a similar purpose. This is a significant step forward in the digitisation of clinical research. Data interpretation can now be performed at a speed previously not possible.
- Earlier understanding of data during the development of a lung cancer drug – for example, risk-benefit, early dose decisions, identification of emerging signals
- Biomarker visualisations – first study to link patient biomarker data with efficacy to understand target lesion response in near real time
- Early closure of an AZD4547 study in Advanced Gastric Cancer (AGC) by 6 months due to an imbalance in benefit/risk which was identified by the clinical team at an earlier stage to make the right decision to terminate enrolment to the study. This enabled adaptation of the translational science/clinical programme strategy, which in turn saved time, resources and study expenditure and allowed AZD4547 to be explored in a new study population, with a new exploratory hypothesis
Has this kit been used in any notable discoveries or activities in AstraZeneca?lols10
REACT is in use in a great number of trials, and particularly those in oncology where we are testing anti-cancer medicines. In those trials, REACT – integrated with other key information sources – is key in helping study physicians and other specialists to make important decisions in the best interests of the patients who participate in those trials. One recent example for a lung cancer drug:
- Earlier understanding of risk/benefit and in-depth analysis of data
- Detected platelet decrease signal, which was characterised and then included in the investigator brochure
- REACT data used to inform dose decision for Phase 2 and Phase 3 studies
Mass spectrometry (or mass spec) is an analytical chemistry technique that helps identify the amount and type of chemicals present in a sample by measuring the mass-to-charge ratio and abundance of gas-phase ions.
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