OPTIMISE: a data capture and management tool to achieve improved pharmacovigilance and develop approaches for stratified medicine in multiple sclerosis (MS)
During a period of consultation between doctors working within the field of MS and industry representatives in 2012-13, it was jointly agreed there was a need for the development of an improved IT tool for gathering and managing large datasets to derive information relevant to pharmacovigilance and stratified medicine in MS. Design requirements for such a tool were identified to involve capture of clinical, patient-centred, genomic, biomarker and imaging data and their secure management and analysis within a low cost, scalable IT environment. Effective deployment of such a tool would facilitate greatly improved treatment for individual MS patients and better inform doctors, the health service and industry about patient needs.
To address this need, a joint project between Imperial College London and Biogen Idec Ltd, named OPTIMISE, has been initiated. The project will be open to additional partners who share the common joint working objectives and contribute to the tool’s development and dissemination to relevant healthcare stakeholders.
The first stage of the project is intended to develop a monitoring and database tool for the characterisation of MS patient populations and their responses to treatment (the “Optimise Portal”) within a 3 year time period. The software infrastructure will be based on the eTRIKS platform with associated hardware, apps and sensors to capture data from clinicians and patients. Initial work will involve piloting the use of the tool (based on design criteria and expert concept input from both partner organisations) within the clinical environment of Imperial College London and other UK clinical academic partner organisations that may be involved. The intended output is a validated, fit for purpose tool that is able to be shared broadly through open release to relevant stakeholder groups. A subsequent, second stage of the project is planned (subject to additional funding) that will involve a much larger number of clinical centres and industry partners for the gathering of sufficient data to enable pharmacovigilance and stratified medicine predictive algorithms to be developed.
An initial workplan has been defined by Biogen Idec Ltd and Imperial College London representatives with the formation of a Joint Project Group for oversight of progress made relative to intended objectives. Outcomes will be disseminated as conference proceedings and on a dedicated website hosted by Imperial College London (www.optimise-ms.org).
OPTIMISE is supported by Biogen Idec Ltd