Photography: Getty Images
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For a growing number of trial sponsors, the clinical research process involves the use of a mix of stand-alone electronic
systems designed to automate and streamline various aspects of the development process. Members of the sponsor's clinical
research team, clinical sites, and contract research organizations (CROs) are likely to interact with multiple eClinical systems
throughout the life of a trial, including tools that handle activities ranging from study build to data capture to trial management.
As these systems become modus operandi in clinical trials, getting them to work together and easily share data can allow sponsors
to realize additional benefits and further improve trial efficiencies and data management.
The next step
With the increasingly widespread adoption of eClinical tools, sponsors are now looking to integrate systems so that data captured
through various technologies can be viewed together or compared for monitoring and decision making. Clearly the industry has
much to gain from a more holistic, end-to-end process in which clinical and operational data are now accessible earlier in
the clinical trial, without the effort of manual and ad hoc batch transfers. This availability of combined data promises to
facilitate efficient and effective decision-making and enhance the overall drug development process.
A vivid example of the significant potential gains from integrating clinical systems is the opportunity to link two separate
and important sources of subject data: patient reported outcome (PRO) data, which subjects personally record, and case report
form (CRF) data, subject-related data that clinicians enter into electronic data capture (EDC) systems. Recently, more and more trial sponsors are asking subjects to record self-observations and measurements to better understand
drug effectiveness and safety. For example, PRO systems are often used to capture subjects' pain-related data, enlisting them
to record their pain level several times a day. Such PRO data has become an important component of drug development.
Figure 1. Medidata Rave provides users with an integrated view of both CRF and PRO data.
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At the same time, the potential unreliability of traditional, paper-based PRO data has become well known, as sponsors note
subjects' tendency to complete paper forms, for example, just before a doctor visit rather than on the schedule given by the
trial protocol. To bring more rigor to subject data capture, sponsors are increasingly turning to compliance improving electronic
PRO (ePRO) methods. In either a device-based (eDiary) or phone-based (IVR) ePRO system, subject entered data is electronically
time and date stamped and uploaded to secure Web-based applications that enable sponsors and investigative site personnel
to monitor subject and trial progress.
Meanwhile, EDC systems provide computer-based clinician entry and can streamline the clinical trial process to deliver significant
time and cost savings to clinical trial sponsors. EDC systems typically combine data capture and data cleaning in one process,
enabling sponsors to reduce risks and improve efficiencies.
While EDC systems have enabled sponsors to more efficiently capture and manage CRF data (physiological measurements, lab values,
etc.), ePRO systems are often employed separately to collect and report on subject data. Currently, there are combined EDC/ePRO
systems on the market with varying degrees of tools and flexibility. Users will need to investigate and decide which tools
will best integrate with their other eClinical systems.
Why integrate?
For sponsors and site personnel who must enter study data on a regular basis, the multisystem approach requires study users
to log in to two or more system interfaces to view both sets of data. Bouncing between systems to see a complete view of a
given subject's data adds unnecessary steps and no doubt frustration to the site workflow. Ideally, researchers should be
able to access an integrated view of subject data that includes both CRF and PRO data.
