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| home > epc > winter 2001 > electronic data capture - achieving the promise of more efficient trials |
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European Pharmaceutical Contractor
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Internet-enabled electronic data management solutions allow for the electronic capture, storage and near real-time availability of data from multiple locations, whilst promising optimal efficiency in the entire clinical trial process. Wireless solutions extend these capabilities, allowing patients to submit quality of life and other data in real-time and from any location, as well as providing a mechanism for improving patient compliance. With vendors claiming that they can revolutionise the entire clinical trial process, potential clients must stop and examine the feasibility of these claims. Additionally, in order for companies to realise a return on investment into expensive data capture platforms, employee training must encompass and enable all issues impacting the full integration of electronic data capture and management. This is a feat yet to be realised by many.
The Current State of Clinical Trials Data Management
Research has found that in 2000, only five to 10 per cent of clinical trials were electronically enabled. The more widely used paper-based system can lead to both time delays and quality problems. Included in the paper-based process is the manual design and distribution of paper case report forms (CRFs). There are thousands of these paper forms which increases the possibility of loss and damage. In collecting data, a physician or nurse examining the patient manually enters information into a CRF.
Errors, including ticking an incorrect box on a checklist, writing notes in random spaces or providing incomplete information are common. This information must then be transmitted from the investigator site to a sponsor site, during which time data may be intercepted or lost. Once at the sponsor site, data must be entered into the database by two separate people. The purpose of this resource-heavy process, known as double data entry, is to verify that mistakes are not made in transcribing information from the CRFs to the database.
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