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Reading Medical Images in Oncology Clinical Trials

Medical imaging has grown substantially in the last 30 years; it has been estimated that in 2002 over one billion medical images were acquired throughout the world. The technology has developed dramatically and now allows physicians the possibility for diagnosis unthinkable only a decade or so ago.

In the arena of clinical trials, this appreciation has not gone unnoticed and has lead to the development of the so-called imaging core labs (ICLs) (1). This has also led to the development of new imaging read methodologies that further reduce the bias and decrease the subjectivity that has historically been an issue in trials, particularly in oncology. More recently the FDA has taken note of the capabilities afforded using electronic methodologies and the problems of reader bias. It is now recommending, at least in the draft guidelines for imaging products and biologics, that all the images should be read by two independent radiologists (2). By independent it is meant working at different institutions as opposed to at any of the investigator sites where patients were originally acquired for the study. A third and final radiologist is then required for the adjudication process where there are differences in evaluation between the two readers.


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By Dr Colin G Miller, Senior Vice President and Dr Klaus Noever, Director of Business Development & Clinical Affairs in Europe at Bio-Imaging Technologies Inc

Dr Colin G Miller is Senior Vice President of Bio-Imaging Technologies Inc. He began his career as a Research Assistant at the Bio-Engineering Department at the Doncaster Royal Infirmary, UK, in 1987, before moving on to become Clinical Research Associate (CRA) with Syntex Research, Europe. In 1990, he took employment with Procter & Gamble Pharmaceuticals, initially working as a Senior CRA, then moving on to head up the Physical Measurement team, Europe. From 1993 until 1999 Colin was Director of Clinical Services at Bona Fide Ltd, before it was bought by Bio-Imaging. Colin holds a BSc (Hons) in Physiology and Zoology from the University of Sheffield, UK and a PhD from the University of Hull, UK. He has written and co-authored over 40 scientific publications and is Co-editor of the book Clinical Trials in Osteoporosis.

Dr Klaus Noever MD is Director of Business Development and Clinical Affairs in Europe for Bio-Imaging Technologies. He consults on medical imaging in clinical drug development. Major projects that Dr Noever has recently been involved with include oncology, rheumatoid arthritis, osteoporosis and Alzheimer's disease. His previous positions were in clinical R&D at Schwarz Pharma, Boehringer Ingelheim and Siemens Medical Systems. Prior to joining the pharmaceutical industry, Dr Noever worked as a Physician at the University hospitals of Bochum (radiology) and Erlangen (cardiology) in Germany.
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Dr Colin G Miller
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Dr Klaus Noever MD
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