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NEWSLETTER
January 6, 2010
VS Staff Significantly
Expands in 2009
VirtualScopics significantly expanded its project management and operational services teams in 2009 leading the way for a nearly 50% overall increase in staffing company-wide. Adding to an already highly skilled staff, these new hires bring extensive imaging and clinical research backgrounds to their positions.
These hirings reflect VirtualScopics' unwavering commitment to providing our sponsors with the highest level of service in the industry. We understand your need for a responsive, pro-active team focused on providing on-time deliveries. Thus, we took a strategic analysis of our business, maintained our Lean Six philosophy and hired smartly throughout the year. These additions will allow us to offer our present sponsors greater advantages while giving prospective sponsors an important option to consider.
Educational Webinars
to be Offered in 2010
Building upon the popularity of our of 2009 seminar series ("Quantitative Imaging for Oncology Trials"), we will be introducing an online educational webinar series in 2010.
These free webinars will be hosted by our staff imaging experts, Edward Ashton Ph.D., Jonathan Riek Ph.D., and Mark Tengowski DVM, MS, Ph.D., and will touch on an array of subjects such as RECIST 1.1 vs. 1.0 and Quantitative Imaging in Early Development Clinical Trials. Throughout the year the subject matter will touch on a variety of imaging modalities and therapeutic areas. If you have a particular subject you would like covered, please send that suggestion through our web site by clicking here.
Our first webinar will be presented on Wednesday, February 24 at 2PM and last approximately 1 hour. Ed Ashton will expound upon his article in this newsletter in presenting a comparison of RECIST 1.0 vs. 1.1 with recommendations for their use in various studies. More information will follow regarding registration for the webinar.
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Ask Ed: How does RECIST 1.1
differ from RECIST 1.0? Which
should I use for my study?
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Edward Ashton Ph.D.
Chief Scientific Officer |
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RECIST 1.1 includes several important updates, which are summarized in the table below. In general, these changes were intended to reduce the variability in RECIST reads (and therefore the adjudication rate in RECIST studies). However, it is important to understand that in addition, the changes regarding minimum absolute increase for PD (Progressive Disease) and the guidance around non-target lesion (NTL) progression will have the net effect of slightly reducing the probability of calling PD at any given
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time point. As a result, it may be difficult to compare the results of a RECIST 1.1 study fairly to those of a previously conducted RECIST 1.0 study. So, if your intent is to use a historical comparator it may be safer to select RECIST 1.0 for your current study. If your planned study has an active control arm, however, you may want to take advantage of the improved precision provided by RECIST 1.1.
Change |
Rationale |
Net Effect |
| Reduce number of target lesions from 10 (no more than 5 per organ) to 5 (no more than 2 per organ). |
Reduces analysis time, while a number of studies have shown that this change will have minimal impact on overall outcomes. |
May produce a small increase in inter-reader and intra-reader variability due to an increase in differences in selected target lesion sets. |
| Malignant lymph nodes are explicitly addressed - should be measured via short axis rather than long axis. |
Lymph nodes were not explicitly addressed in RECIST 1.0. Measuring short axis vs. long axis for lymph nodes has been shown to decrease measurement variability. |
Should slightly reduce intra-reader, inter-reader, and scan-rescan variability in cases where lymph nodes are included as target lesions. |
| Mandate a 5mm minimum increase in SLD, in addition to the previously required 20% increase, in order to call PD based on target lesion growth. |
In cases with only a few small lesions, PD could previously be called on the basis of changes that are not statistically significant. |
Should reduce the overall number of progressive cases as well as reduce inter- and intra-reader variability. |
| Added more explicit guidance regarding what constitutes unequivocal non-target lesion progression. |
This element was not clearly addressed in RECIST 1.0, and was a source of significant reader variability. |
Guidance for NTL progression is generally more restrictive - should reduce the overall number of progressive cases somewhat as well as reduce inter- and intra-reader variability. |
For more information visit us at: www.virtualscopics.com
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