Strategic Planning: Clinical

Trials Progress
 Breakout Group B

How can this group leverage the existing work in this

forum and the ongoing work at QIBA to facilitate the
drug approval process?
 General comments

Several presentations given at this meeting contain a

very good overview of potential ways to resolve some
of our open questions
 Question 1: How do we build on the precedent
of the Pazopanib and ABIGAIL trials?

 Proposals
– Share imaging protocols and lessons learned
– Share images with the scientific community where
possible
– Potential for participation of other regulatory agencies
in Prevent Cancer meeting
– Discuss approaches to qualify existing volumetric
data with Critical Path Institute
 Question 2: What have we learned from
the Merck quanitation effort?
 David Mozley’s slides contain detailed
summary of challenges/opportunites

 Use retrospective data to better understand

various challenges of implementation of
volumetric endpoints in clinical trials
 Question 4: Should each clinical trial contain a
detailed description of image acquisition?

 Statistical paradigm is slightly different

 Site PIs need to be educated re: radiological rigor

 Radiologists need to be more involved in clinical trials
– Study design
– Investigational site level
 RSNA lead definition of standards?
 Critical Path Initiative involvement?
 Questions 5 and 7:

 How do we change clinical trial reporting to mandate the supplemental

submission of imaging data?
– Is mandatory submission reasonable?
– Impediment to recruitment?
– Academic vs Industry sponsored trials

 Question 7: What do we develop a national (global?) image management

resource?
– Defer to Group A
 Questions 3 and 6:
 How can the clinical community be informed of/move QI to clinical practice?
 How may the imaging community support imaging as a response evaluation biomarker?

– Covered by Gudrun Zahalman and Marietta Anthony’s presentations

 Question 8: How do we create standards
for volumetric assessment?
 Continuous process accumulation and dissemination of data
– Presentations from Gudrun, David, Tony Critical Path Initiative
– Inclusion of Industry partners
– QIBA
– FDA and NIST
– Meta analyses of comparable data where possible
 Question 9: How do we define response?
 Surrogate endpoint for clinical outcomes will be difficult to achieve
 Multiple intermediate comparisons will be necessary and useful
 Opportunity to compare with molecular biomarkers (Pazopanib/ABIGAIL) will be very valuable
 What is needed ?
 Clear outline of the question that
we want to answer – imaging
biomarker that can be used as a
surrogate for drug related tumor
response in lung cancer, esp.
NSCLC that is more sensitive,
accurate than SLD.
 Reliable clinical and study related
imaging procedure.
 Reliable imaging analysis.
 Reliable data management (do
not corrupt).
 Proven Relationship of the
imaging biomarker to clinical
outcome.
 Understanding what imaging
procedure is relevant for the
question that we want to answer –
high resolution CT.
 Definition what do we mean by high
resolution: is it 0.75 or 5 mm? Other
scan parameters?
 Selection of relevant scanners.
 Standardized study protocol for all
relevant CT scanners.
 Site qualification according to the
protocol.
 Standardized phantom scans
across scanners.
 Ongoing quality inspection on a per
scan basis.
 ….