The cost of clinical trials has risen to almost 60% of total development costs, compared to 30% in the 1980si. According to The Centre for Information and Study on Clinical Research Participation, a single day lost in trials can cost sponsors as much as US$8 million in lost sales opportunities. Pharmaceutical, biomedical and healthcare companies need to ensure that returns on every dollar of investment are optimized. This is one reason why clinical trials are witnessing an increasing adoption of tools and applications such as IVR (Interactive Voice Response) and IWR (Interactive Web Response) at trial sites for patient enrolment, tracking and management of supplies, patient diary data collection, etc. These are typically real-time data collection tools and pose a problem when EDC (Electronic Data Capture) records lag by 2 to 3 weeks. The loss in efficiency and quality can be considerable. This is even more accentuated as medical practitioners now have mobile devices that allow them to review lab and clinical trial data directly and in real time.
EDC itself has been responsible for inefficiencies. In one recent survey of clinical study site staff, 46% of respondents said they had to do more work due to EDC compared to 23% some years agoiii. Clinical study teams have a natural affinity for traditional pen-to-paper workflow processes that are central to data collection before the data is fed into an EDC system. These limitations of EDC and paper sources can be overcome using what is called Electronic Source Record (eSource). eSource delivers the following key objectives:
- Electronic capture of the initial source document/ data
- Site-centric user interface that facilitate patient interactions
- Remote viewing of source documents and not just the data
- Integration of patient clinical records and medical information
- Using the eSource system as eCRF (electronic Case Report Form) platform eliminates eCRF design/ hosting
- List of building blocks (test/ test panels/ forms) to set up a study
- Automated lab data integration
eSource supports the acquisition of data from multiple sources, creating a single source of truth. Data can then be managed, transformed and distributed using this single, standard infrastructure. In addition, new age technologies such as NFC and Eye-Fi can help acquire data directly from various devices and systems such as CPU, HR monitor, blood pressure monitor, lab analyzers etc. Data entry personnel will not need to spend hours transferring paper records to electronic databases after the visit.
eSource needs data to be entered once, greatly reducing the burden on the study site. This translates into a higher number of trials, improved speed of trials, reduced queries, elimination of source data verification, adherence to protocol, reduced errors and enhanced quality. Since the source document is electronic, a robust audit trail is possible.
Most importantly, sponsors get clean data in real time aiding faster and more accurate trial results.
i The Centre for Information and Study on Clinical Research Participation: http://www.ciscrp.org/professional/facts_pat.html