CEO · The Bracken Group

Colin G. Miller, PhD

FIPEM · CSci · Chartered Scientist
Internationally recognized expert in medical imaging for clinical trials, with 35+ years leading imaging science across oncology, osteoporosis, osteoarthritis, neurology, and metabolic disease.
35+Years in Field
80+Peer-Reviewed Publications
3Authored Books
3Patents
 

Executive Summary

Colin G. Miller, PhD, FIPEM, CSci, is one of the world’s foremost authorities on the use of medical imaging as an endpoint in pharmaceutical clinical trials. With a career spanning more than three decades — from pioneering ultrasonic attenuation research for hip fracture prediction to designing state-of-the-art imaging core lab strategies for NGF inhibitor programs — Colin brings unmatched scientific depth and operational experience to every engagement.

As founding partner and CEO at Bracken, Colin advises pharmaceutical companies, CROs, and regulatory bodies on imaging strategy, imaging core laboratory selection and oversight, quantitative imaging biomarker development, and reader methodology. His expertise spans osteoporosis, osteoarthritis, oncology, neurology, metabolic disease, and nuclear medicine (PET/SPECT). He has contributed to landmark FDA advisory panels, authored three Springer textbooks on clinical trial imaging, holds three imaging-related patents, and has co-authored guidelines for OARSI, STAIR, and the Radiology Society of North America.

Clients engage Colin when they need imaging decisions made with scientific rigor, regulatory intelligence, and real-world trial experience — getting it right the first time.

 

Case Studies

View all case studies →
 

Patents

Patent 01
Calcium Hydroxyapatite Phantom for DXA Instruments
Standard reference phantom for dual energy X-ray absorptiometry cross-calibration
Patent 02
Variable Composition Body Composition Phantom for DXA
Adjustable-composition phantom enabling precise body composition assessments in clinical trials
US2009297012-A1
Automated Vertebral Characterization from Digitized X-Ray
Statistical shape modeling method for automated mammalian spine characterization. Co-inventors: Brett A, Haslam J, Hayes C, Krasnow J, van Kuijk C (WO2009154977-A1)
 

Authored Books

 
Springer · 2014
Medical Imaging in Clinical Trials
Miller CG, Krasnow J, Schwartz LH.
ISBN 978-1-84882-710-3
 
Springer · 2008
Clinical Trials in Rheumatoid and Osteoarthritis
Reid DM, Miller CG.
ISBN 978-1-85233-874-9
 
Springer · 2002 / 2nd Ed. 2007
Clinical Trials in Osteoporosis
Pearson D, Miller CG.
ISBN 1-85233-229-8
 

Career History

2015 – Present
President, CEO & Founder
The Bracken Group dba Bracken Data, Inc.
2015 – 2018
Partner
Alacrita
2006 – 2015
Senior Vice President, Medical Affairs
BioClinica, Inc. (now Clario)
2003 – 2005
Senior Vice President, Business Development
BioClinica, Inc.
1999 – 2003
Vice President, Business Development
BioClinica, Inc.
1994 – 1999
Director of Clinical Services
Bona Fide Ltd. (subsidiary of Lunar Corp., acquired by BioClinica 1999)
1992 – 1993
Head, Physical Measurements Team Europe
Procter & Gamble Pharmaceuticals
1987 – 1990
Clinical Research Associate
Syntex Research, Dept. of Clinical Pharmacology & Therapeutics Investigation
 

Thought Leadership

 
Article · Industry History
30 Years of the Imaging Core Lab Industry
A first-person account of how imaging core labs emerged, matured, and became essential infrastructure for clinical trial integrity — from someone who was there for all of it.
 
Article · Oncology Imaging
Time to Rethink RECIST 1.1?
A critical examination of whether the most widely used oncology response criteria is still fit for purpose in the era of immunotherapy and targeted agents.
 
Article · Reader Methodology
Why Readers Vary When Interpreting Clinical Trial Images — and When to Worry About It
Explores the sources of inter-reader variability in imaging endpoints, what level of disagreement is acceptable, and how to design studies that control for it.
 
Article · Nuclear Medicine
Novel Read Methodology in Nuclear Medicine for Neuroendocrine Tumors
How new approaches to image reading are improving the reliability of response assessments in GEP-NET trials — and what sponsors need to know before they design their next study.
 
Article · Trial Operations
Are Reader and Radiologist Calibration Meetings Important — or Unnecessary?
The case for (and against) calibration meetings in clinical trials, with practical guidance on when they add value and how to structure them for maximum impact.
 
Article · Trial Management
5 Documents Critical for the Success of Clinical Trials with Medical Images
The essential documentation framework every sponsor should have in place before imaging data starts coming in — and what goes wrong when any of these are missing.
View all of Colin's articles →
 

Selected Publications

  • 2022
    A Randomized, Factorial Phase II Study to Determine the Optimal Dosing Regimen for 68Ga-Satoreotide Trizoxetan as an Imaging Agent in Patients with Gastroenteropancreatic Neuroendocrine Tumors
    J Nucl Med · Virgolini I, Bahri S … Miller CG, McEwan S, Czernin J.
  • 2021
    Radiologists and Clinical Trials: Part 2 — Practical Statistical Methods for Understanding and Monitoring Independent Reader Performance
    Therapeutic Innovation & Regulatory Science · Raunig DL, Schmid AM, Miller CG, et al.
  • 2021
    Radiologists and Clinical Trials: Part 1 — The Truth About Reader Disagreements
    Therapeutic Innovation & Regulatory Science · Schmid AM, Raunig DL, Miller CG, et al.
  • 2021
    A Novel Read Methodology to Evaluate the Optimal Dose of 68Ga-Satoreotide Trizoxetan as a PET Imaging Agent in Patients with Gastroenteropancreatic Neuroendocrine Tumours: A Phase II Clinical Trial
    EJNMMI Research · Miller CG, Grønbæk H … McEwan S.
  • 2017
    Development of an Imaging Mitigation Strategy for Patient Enrolment in the Tanezumab Nerve Growth Factor Inhibitor (NGF-ab) Program with a Focus on Eligibility Assessment
    Seminars in Arthritis and Rheumatism · Roemer FW, Miller CG, West CR, et al.
  • 2016
    A DXA Whole Body Composition Cross-Calibration Experience: Evaluation With Humans, Spine, and Whole Body Phantoms
    J Clinical Densitometry · Krueger D, Libber J … Miller CG, Binkley N.
View all of Colin's publications →

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