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| home > epc > summer 2004 > quantitative image analysis in clinical trials - current standards and future developments |
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European Pharmaceutical Contractor
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The use of imaging is an established method in defining primary and secondary endpoints in clinical trials. The tremendous technological improvements in the performance of imaging equipment and software tools have played an important role in the application of imaging for study outcome purposes. Eight to 10 years ago, standard X-ray angiography was still stored mainly on 35 cinefilm and plain film and required precious film development processes in-hospital to guarantee good quality of the angiograms. At that time replacement of this proven concept by digital cath lab systems with DICOM compatible standards linked to a digital storage and archiving infrastructure started and took place in a few years. Although the spatial resolution of digital images with 5122 matrix sizes is slightly below that of cinefilm, the better contrast resolution and the advantages of computerised evaluation processing and archiving, in combination with the option for semi-automatic quantitative assessment of the images on workstations with dedicated software, facilitated the change to a digital standard.
More recent technological developments are directed towards non-invasive imaging approaches. The use of, for example, fast MR and multi-slice CT scanners has become widespread in many therapeutic areas, for diagnostic purposes as well as for clinical research applications. These three- and four- dimensional imaging techniques, through subsequent acquisitions in the same imaging session, allow for the assessment of multiple parameters of an object. In addition, clinicians can gain increasingly detailed information on the appearance and status of a diseased organ and the short and long-term monitoring of the efficacy of the treatment. Hence, imaging has been accepted as a valuable tool in the assessment of inclusion and exclusion criteria for patients participating in clinical trials and the subsequent offline interpretation of these images at an independent image analysis core lab.
The classical method of evaluating the efficacy of a particular treatment is to set up a reading session in which two clinicians, such as radiologists or cardiologists, review the images in a randomised and blinded fashion. In the event of a discrepancy between the two readers, a third expert will adjudicate. Although these interpretations may be important from a clinical point of view, and sometimes even the only option for image review, the lack of concrete quantitative data usually requires large numbers of subjects to be evaluated for the study endpoints.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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“PACK DIFFERENT” with EMBALLAGE 2008
“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
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