Thought Leadership | The Bracken Group
Thought Leadership

Perspectives shaping the conversation in life science

Timely points of view from the people behind Bracken's work — on AI and clinical judgment, imaging endpoints, patient-focused development, and real-world evidence.

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Clinical Development

Overview: Understanding Operation TrialBlazer for Early Drug Development

The Bracken Group

Operation TrialBlazer aims to make the U.S. the fastest place to start a trial. Here's what's in force, what is proposed, and what sponsors can do next.

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Radiopharma Roundtable

Designing Your Imaging Endpoint as a Measurement System

The Bracken GroupRadiopharma Roundtable · Session 1

A trial's imaging endpoint is a full measurement system, not a single scan. Here are the choices that drive data quality before the protocol locks.

Colin G. Miller, PhDCM
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Clinical Development

What Operation TrialBlazer Means For Clinical Trial Imaging

Colin G. Miller, PhDCEO

Reducing administrative delay shifts the burden to imaging endpoints as early go/no-go judgment becomes the binding constraint.

Paul Martinetti, MDPM
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Imaging & Endpoints

Beyond Weight Loss: DXA in the GLP-1 Era

Paul Martinetti, MDBracken Consultant

With GLP-1 therapies, body composition, not the number on the scale, is the outcome that matters. Why DXA is emerging as the endpoint of choice.

Martin Collyer, MSc, FCCAMC
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Patient-Centered

Embedding the Patient Voice in Drug Development

Martin Collyer, MSc, FCCASenior Partner

Patient-focused drug development is now an expectation, not an aspiration. What it takes to embed the patient voice with genuine global vision.

Colin G. Miller, PhDCM
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AI & Judgment

Judgment-Led Advisory in the Age of AI

Colin G. Miller, PhDCEO

As AI reshapes how decisions get made, where does expert human judgment still matter most? A case for why the best advisory work is becoming more human, not less.

Alexander (Sandy) McEwanSM
Colin G. Miller, PhDCM
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Imaging & Endpoints

Limitations of SUV Quantitation in Phase 0 PET Trials

Colin Miller & Sandy McEwanThe Bracken Group

Is standardized uptake value the right metric for the earliest-phase trials? The case for alternative endpoints when the science demands precision.

Martin Collyer, MSc, FCCAMC
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Data & Evidence

The Transformative Impact of Real-World Data

Martin Collyer, MSc, FCCASenior Partner

Real-world data is changing how evidence is generated across the product lifecycle, but rigor still has to catch up in places.

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