Views on the role of IT and its use in clinical research are evolving. Outsourcing in clinical trials is just one aspect of this evolution; a journey that a number of firms such as Eli Lilly, Almirall and Pfizer have already begun. Online patient communities such as those invested in by Quintiles, to help address the patient recruitment imperative, are a further example of technology stepping into the trial process.
As study sponsors and trail managers determine the role of IT in supporting their clinical trials and aim to improve on their previous study outcomes, they have to do this whilst also juggling potential recruitment and/or retention staff issues , multiple trials at different stages in trial lifecycle and management of different CRO partners, potentially under varying contract relationships. Implementation of IT in trial conduct therefore has to be flexible. One such flexible IT approach has been taken by ICON. The company is a global CRO for the pharmaceutical, biotechnology and medical devices industries and offers its clients both an ‘a la carte’ menu of technology solutions and an integrated technology solution. ICONs individual but connected product suite consists of:
- ICONPhone – platform for delivery of voice and web response services (IVR and IWR)
- ICONPhone ePRO – application offering real-time access to and fast validation of patient data
- ICON MIRA – ICONs medical image review and analysis system
- IKE – an image based knowledge management portal providing access to study data and tools
- ICOSpeedRead – an independent image review system to quickly get the image review process up and running.
- ICON IMRA – ICONs medical review application is a web based laboratory tool providing 24/7, global access to laboratory data on a client’s study.
- PDxPOP – a software tool for speeding up iterative process of pharmacokinetic population modelling and analysis
For clients seeking a more end-to-end solution for trail management, the company offers ICONIK (ICON Integrated Knowledge) which combines the firms’ technology products to form an integrated system providing a single view of study performance metrics and data to both sponsor and CRO trial teams. The ICONIK clinical data repository is based on Oracle’s Life Sciences Data Hub and pulls clinical and non-clinical data into a single environment including imaging and laboratory data. It consolidates and standardises operational, safety, quality and efficacy study data from multiple sources and combines this data knowledge base with data analysis, reporting and visualisation tools.
For some study sponsors, full implementation of ICONIK may simply be too ambitious. However, ICON’s technology solution portfolio presents sponsors with a range of technology support options that each aim to improve the efficiency and effectiveness of clinical trials. For those companies with multiple drug or device developments in the pipeline, who are dealing with different resourcing profiles for their trials and who wish to be able to make different outsourcing decisions per trial, it is clear that IT can offer them a more pivotal role in trial operation and management. The level of flexibility increasingly required by study sponsors will necessitate centralised control of data standards, both proactive and responsive project management and clear data transparency. This in turn clearly indicates a strong IT backbone for trial management. The solutions offered by ICON appear to appropriately reflect the realities of large sponsor firms today.
But who oversees integration with corporate systems?
IT should and actually can do more. We saw external forces such as new governance guidelines or new trial management staff are the two principal reasons for additional funding for IT in clinical trials, representing almost 40% of the responses from participants in our mind the gap study. Nevertheless, other budget drivers included trial benchmarks, past compliance issues, past trial delays and the desire to exploit new technology. Clearly IT has a role to play in addressing all of these business issues. However, it is also clear from the study, that not all trial teams systematically or effectively review IT performance to determine where improvements can be made. Yet when the outcomes and benefits from IT introduction are indeed assessed then improved accuracy, improved communications, faster time to results and reduced costs all feature.
More significant for sponsors’ long term research and compliance fitness is how data from each trial is integrated with corporate research systems. Whilst it is encouraging that CROs like ICON are investing to optimise trial operations, we believe sponsors should pay careful attention and ensure data portability.