Medical Imaging
in Clinical Trials

Medical imaging is used for eligibility, safety and efficacy endpoints in clinical trials. The Bracken team builds on years of strategic and operational experience to help clients develop and design the imaging aspects of their clinical trials for both biopharmaceutical products and novel diagnostic imaging products.

• Having worked at imaging core labs and embedded imaging teams at pharma companies, our experts have rare, in-depth knowledge of how medical imaging can be used to provide biomarkers in clinical trials and help get products to market.
• One of our founders, Dr. Colin G. Miller, is a co-author of Medical Imaging in Clinical Trials. Published by Springer, the book is the “go-to” text for anyone using medical imaging in clinical trials.
• Most recently, the Bracken team has been at the forefront of the growth of radiopharmaceuticals, both in the development of novel diagnostics and in the rapidly developing field of theranostics.

The use of medical imaging in clinical trials continues to grow, as imaging allows scientists and doctors to probe the body and develop precision medicine techniques. The endpoints are only as good as the medical image acquisitions and the readers (radiologists) who evaluate them.

The experience of working at the intersection of medical imaging and clinical research has provided the Bracken consulting team with the knowledge and insight to help you:

1. Select the appropriate imaging endpoints for your trial so that you can most readily make go/no-go decisions. Optimize the protocol language for your imaging endpoints to reduce costly protocol revisions.
2. Survey the imaging literature to evaluate level of validation and potential gaps in proposed endpoints. Help you connect with KOLs to help achieve maximum scientific credibility.
3. Help ensure the imaging endpoints are robustly implemented.
4. Work with your team to develop a request for proposal and select the best CRO to implement your imaging study. Ensure that you are only paying for the imaging services you need for your study's integrity.
5. Help manage your vendors to ensure quality delivery of the data.
6. Represent your team’s interests in delivering the study.

Bracken can help you identify the best imaging core labs to meet your requirements. How? By asking the right questions:

Medical imaging: Questions to ask

• Which imaging core lab should you select? They all have their key strengths, but which ones match your needs?
• What kind of read should we employ? 2+1? Forced or open adjudication? How many readers?
• How should we assess intra and inter reader availability? What should the adjudication rate be for this indication?
• Should I have a radiology calibration kick-off meeting?
• Local sites have radiologists. Why don’t we leave it up to the local experts to make the decision?
• Is a central read cost effective in my clinical trial?
• What type of read should I use for oncology: RECIST 1.1? Lesion volume? Lugano? RANO? Other modifications?
• What type of read in osteoarthritis/osteoporosis/rheumatoid arthritis
• Do I need a radiologist reading DXA studies?
• Does the Imaging Charter capture the necessary details?

Most core labs lack staff that have directly worked in the pharma/biotech industry, and therefore may not understand the nuances and key decision processes. Likewise, most pharma staff do not have in-depth experience in medical imaging. Bracken is here to bridge these gaps in knowledge.