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International Clinical Trials

Clinical Teams and Tools

New approaches for smarter clinical trials come under review, as Hui Li and Eva R Miller of ALMAC Clinical Technologies go in search of a strategic plan

Doing things the same way and expecting different results. Most of us are familiar with this definition of insanity. Thus, improving the clinical trial process requires that we find new ways to work more efficiently and effectively. In short, we need to work smarter. Improved collaboration and the better utilisation of technology are areas that hold promise for improving the clinical trial process. In both cases, doing things the same way we always have won’t result in the outcomes we are hoping for. Instead, we need to break the mould and find new ways to leverage the tools and talents that are available.

THE POWER OF EDC

Electronic data capture (EDC) systems are cost effective when they help sponsors process their data more efficiently, in effect by ‘keeping the end in sight’. If teams anticipate study reports and filing as they develop an EDC system, only information that is really necessary is collected and cleaned. In addition to the efficiency this brings to the data collection process, it also eliminates the risk of getting to the end of the study and realising that essential information is missing. Modern EDC technologies have the potential to help clinical research teams collect data in a much more precise, rapid and accurate way, which in turn results in high quality data, ready for analysis more quickly.

The implementation of EDC has caused changes in the roles of various members of the clinical team. The teamwork of statisticians, data manager and other team members in the establishment of EDC trials is essential. Wise planning in the use of EDC technology allows for cleaner data to be entered into the clinical trial; it is more accurate, comprehensive and timely.

CHANGING ROLE OF DATA MANAGERS

Traditionally in clinical trials, data has been collected on paperbased case report forms (CRFs). After the CRFs are completed, batched and transmitted, the data managers perform edit checks to make sure there are no obvious mistakes, and all the required fields have been completed. The CRFs are then entered into the database manually or scanned by a text-recognition device such as an OCR. Again, the data in the database needs to be compared against the original documents in order to make sure that no errors have been introduced during the digitalisation process (1).


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Hui Li, Biostatistician at ALMAC Clinical Technologies, gained a Master’s from Rutgers, the State University of New Jersey. Hui has served as a Biostatistician, providing randomisation lists generation and statistical consulting services for a broad range of clients. She is also involved in the development of electronic data capture and electronic patient report outcomes.

Eva R Miller, Head of Biostatistics at ALMAC Clinical Technologies, holds a PhD from the University of Pennsylvania. At ALMAC, she oversees development of EDC and randomisation modules for clinical trials. Eva has served as a Biostatistician in clinical trials spanning Phase I through Phase IV in a broad range of therapeutic areas. Eva’s most recent research has focused on innovative designs for clinical trials, logistics for implementing adaptive trials and adaptive randomisation designs.

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Hui Li
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Eva R Miller
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