CTSC:multicenter042110

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Agenda

1. Definition of goals for this new subgroup
2. Learn from existing multicenter trials

Multicenter Clinical Trial Working group Meeting Minutes April 21, 2010

In attendance:

• Valerie Humblet
• Bob Lenkinski
• Clare Tempany
• Charles Guttmann
• Simon Warfield
• Jeff Yap
• Neil Rofsky

1. Goals

• The main goal of this group is to set up a imaging trial across Harvard. It could be a virtual trial (no need for funding) or a real trial. Several modalities must be considered.
• The goal is to start with a simple example and then go for more complicated examples.
• Being able to do a successful cross-Harvard imaging trial is be very good with the perspective of the CTSA grant renewal.

2. Discussion

• Validation is key, consistency of results is crucial. Reproducibility across sites and across vendors must be achieved.
• Jeff suggested to look at some of the existing, already funded multicenter trial and see if we could help them wirk on a better reproducibility across site. He cited the example of neuro-oncology trials with DCE-MRI. So far the acquisitions are not standardized across institutions. At DFCI they are now testing the sequences used by Greg Sorensen at MGH.
• Simon agreed, the same problems exist in pediatric neuro-oncology. He suggested to do a simulation to be able to show that by using protocols that are not standardized one gets different results. Bob confirmed that validation would be doable in this case between CHB and MGH.
• Charles has data of longitudinal studies (people are scanned on the same scanner). In clinical trial for MS, people were scanned monthly (MRI) with injection of contrast agent. The new approach is to do subtraction in a longitudinal study. The result: 80% less scan with the new method and very good measures to see if the treatment works. References: Duanajrn2009.pdf , MoraalAnnalsNeurol2010.pdf, MoraalRadiology2009.pdf
• Analysis is also a key component, most of the time, the analysis arm is the part that fails.
• Bob is in touch with Cecil Charles from Duke University who has extensive experience in conducting longitudinal clinical trials with MRI and MRS used as biomarkers.

3. Actions items

• Inventory of CT, PET, MRI multi-institutions imaging trials that are enrolling.
• Inventory of equipment (research scanner and software) (Valerie)
• Inventory of protocols for MRI for women with high risk of breast cancer (Neil)
• Catalogue of analysis tool
• Jeff will provide documentation from DFCI on how to do a clinical trial