Can these digital advances revolutionise clinical data?
Four leaders in oncology research are creating a way to support early decisions in clinical trials, supported by innovative technology
Real time eDecisions in clinical trials
The treatment of cancer is moving into a new era. The growing understanding of the genetic and biomarker profiles of tumours makes the possibility of truly personalised medicine treatment tailored to the individual’s tumour molecular profile within our grasp. If this aspiration is to be realised, experts will need to work closely together to harness our evolving knowledge. A more open collaboration will be needed, alongside rapid evolution of genomics and relevant biomarkers, optimisation of clinical trial designs, application and culture, together with providing large volumes of data in a timely and understandable format.
Collaboration
Collaboration between many experts is required to optimise our understanding of new cancer treatments, whilst maintaining patients’ safety and assessment of the benefit/risk profile. In addition to the medical staff and scientists, the patients themselves are often the knowledge leaders in their own disease and should have the opportunity to be empowered to speak up and become active partners rather than the silent contributors that they, and we, are used to.
The ‘iDecide’ framework, has been designed to facilitate the partnership and collaboration necessary to capitalise on the scientific advances for the benefit of patients. ‘iDecide’ is a five-year collaboration between four leaders in oncology research; The University of Manchester Institute of Cancer Sciences, The Centre for Cancer Biomarker Sciences, The Christie NHS Foundation Trust Research Division, and AstraZeneca. ‘ iDecide’ aims to create a clinical trial culture which is collaborative and innovative.
Delivering precision medicine
‘iDecide’ is a clinical trial bioinformatics research and development framework to support early decisions in clinical trials. It leverages real-time patient information during an ongoing clinical study with the dual purpose of enabling early decisions and supporting effective adaptation of the clinical trial design for the patient’s benefit.
Through the advanced genomics approaches employed by the Manchester Centre for Cancer Biomarker Sciences, ‘iDecide’ aims to improve the availability of molecular selection data to patients and researchers. Using this approach all relevant data can be integrated, maintained and assessed during the study enabling optimal cancer therapies to be matched to patient benefit.
Technological solutions
A key component of the ‘iDecide’ framework is access to real-time data to enable real-time decisions to adapt the clinical trial. The two technology solutions to enable real-time eDecisions in clinical trials are REACT and PROACT.
REACT (Real-time Analytics for Clinical Trials) is revolutionising clinical data interpretation and visualisation in ongoing clinical studies. It provides experts with real-time access to integrated clinical trial data such as exposure, safety, efficacy and biomarkers. This enables more informed reasoning, decisions enabled by all available information (eDecisions) and an earlier understanding of the patient benefit-risk trajectory.
PROACT (Patient Reported Opinions About Clinical Tolerability) is an industry-leading system, designed around the ergonomics of the patient, which gives patients a user-friendly way to get involved. They can link to their anchor person at site, and also directly share whatever experiences they have with all relevant experts, including the study sponsor. It’s mobile, quick, and entirely on their own terms: whatever they want to share, whenever they want to share it. In return, patients can receive study-updates from their medical team so that they can learn along with the experts around them.
The sharing and real-time access to this data gives experts a chance to work together to strengthen the link between emerging science and patient-driven needs to inform their treatment decisions enabled by integrated bioinformatics (eDecisions).
Moving forward
‘IDecide’s vision is to transform the bioinformatics landscape within a clinical trial. The framework and collaboration will continue to evolve and build on this foundation; providing patients access to their own data so that they can become an active participant and collaborator in their own healthcare; developing and enhancing bioinformatics systems. This means that all experts, including patients, can continue to work together as a team, striving to evolve the science of cancer medicine.