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Validation
of Medical Imaging in
Clinical Development |
Product
Development
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FDA
Guidance Document advocating the use of medical imaging
endpoints in clinical trials "Providing Clinical
Evidence of Effectiveness for Human Drug and Biological
Products", March 1997. |
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FDA
releases in 2000 "Guidance For Industry: Developing
Medical Imaging Drugs and Biologics"; FORESIGHT's
management played an active role in the development
of this document. |
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FDA
releases initiative "Reinventing the Regulation
of Cancer Drugs", March 1996, stating that
the "FDA will substantially expand the use of
accelerated approval process for cancer treatments,
based upon verified and recognized demonstration of
objective tumor shrinkage", i.e., medical imaging
endpoints. |
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President signs legislation establishing the National
Institute of Biomedical Imaging and Bioengineering
at the NIH, December 2000. |
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"Advances
in technology have now made imaging an important,
non-invasive tool for the functional or quantitative
assessment of biochemical, genetic, or pharmacologic
activity. Imaging modalities, such as magnetic
resonance spectroscopy (MRS), positron emission tomography
(PET), and single photon emission computed tomography
(SPECT), are uniquely suited to this challenge. These
techniques are ready to be incorporated into early
clinical trials of therapeutic agents."
National
Cancer Institute, Scientific Rationalization: Request
for Applications (RFA) CA-98-024, 1999 |
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Imaging
is needed in clinical trials for three fundamental
purposes:
- To select subjects
most appropriate for study or treatment
- To monitor disease
progression and therapeutic response
- To monitor complications
of the disease or therapy
In
addition to supporting definitive testing in Phase
III of drug development for regulatory approval,
imaging also facilitates internal decision making
in Phase II about which compounds to prioritize.
This includes proof-of-concept studies, dose-selection
studies, patient-typing studies, etc. Here, an early
readout is particularly valuable…. There is
a huge upside to rapid decision making in the competitive
arena of drug development.
From
the National Institute of Arthritis and Musculoskeletal
and Skin Diseases: The Osteoarthritis Initiative
Imaging Subcommittee Meeting: Imaging in Drug Development
and Clinical Trials, January 11, 2000
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MEDICAL IMAGING TOOLS
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CT
(Computed Tomography) helical/spiral, multidetector,
CT angiography, virtual endoscopy/colonoscopy |
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Digital
X-ray Radiography and Fluoroscopy |
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Interventional
Radiology catheter-based diagnosis and
therapeutics |
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Mammography
conventional x-ray, digital, magnetic resonance (MR)
mammography, image guided biopsy and therapy |
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Molecular
Imaging nuclear
medicine radiotracers, SPECT imaging, PET (positron
emission tomography) |
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MRI
(magnetic resonance imaging)
functional organ imaging, quantitative
perfusion, 3D tumor measurements, MR angiography,
organ-specific contrast agents, combined imaging and
spectroscopy, T1 rho measurements (protein degradation),
real time examinations, MR microscopy |
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Optical
Imaging pathology/organ
specific dyes, systemic vs. local |
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Ultrasound
video motion studies, quantitative Doppler flow, contrast-enhanced
perfusion, elastography |
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©2001
Foresight Consulting LLC |