Helping your team through the strategic & operational aspects of imaging endpoints in clinical trials.
Medical imaging is used for eligibility, safety and efficacy endpoints in clinical trials. The Bracken Group team has had years of experience helping clients develop and design the imaging aspects of their clinical trials for both biopharmaceutical products and novel diagnostic imaging products.
Our strategic and operational support for medical imaging in clinical trials.
Helping you develop your clinical trials and maximizing your imaging endpoints:
- Ensuring the clinical trial protocol imaging section matches your endpoint:.
- Does the Imaging charter capture the necessary details?
- Most biopharma companies do not have imaging experts; TBG is able to fill that void.
- Experience across the broad range of therapeutic areas and a comprehensive knowledge of imaging modalities.
- We have helped develop new diagnostic products.
- What type of blinded read do I need: A 2+1 design or something else? TBG can help you work through this.
- Should I have a radiology kick-off meeting?
The Bracken Group has the experience you can count on.
Our team has many years of growing imaging core labs (TBG is not an imaging core lab / imaging CRO) or being part of a pharma company embedded imaging team. We know the challenges of understanding your imaging endpoints and ensuing the meet the right goal. There are many stories of products that have failed and when reviewed, it is the imaging that has failed but not the drug or device, (by which time it is too late to rescue the failed clinical trial and the product dies).
Our co-founder wrote the book Medical Imaging in Clinical Trials, which has become the go-to reference in the industry. Imaging is constantly changing and being updated, so there are new nuances that need to be considered.
The use of medical imaging in clinical trials continues to grow, as imaging allows us to probe the body and we develop precision medicine techniques. The endpoints are only as good as the medical image acquisitions and the readers (radiologists) that evaluate the images. TBG can help bridge those gaps: helping you identify the best imaging core labs that fit with your requirements (they all have different strengths). Which read paradigm should be considered, and who are the readers being used for the trial, or would you like to tap into our network?
As Steven Covey wrote “Begin with the end in mind” and no-where is this more important than in the management and read design of your imaging endpoints. Contact TBG for a free hour consult for to evaluate if your imaging is matching your endpoints and objectives.
- PET (both FDG-PET and other radionuclides)
- Optical coherence tomography (OCT)
- Ultrasound/Bone Ultrasonometry
When using medical imaging in a trial, here are some questions to ask:
Which imaging core lab should you select? They all have their key strengths, but which ones match your needs. Most core labs lack the staff that have directly worked in the pharma/biotech industry, so the understanding of the pressures and decision processes are limited. Likewise, most pharma staff do not have the in-depth experience in medical imaging and hence there is a knowledge gap which TBG bridges.
What kind of read should we employ? 2+1? Forced or open adjudication? How should we assess intra and inter reader availability? What should the adjudication rate be for this indication?
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?
Specific therapeutic areas of consultation in clinical trials:
- Solid turmors
- Novel radionuclide diagnostic products
- Protein Receptor Radionuclide Therapy (PRRT)
- Knee OA
- Hip OA
- Anti-Nerve growth factor (anti-NGF) products (Safety issues)
- Vertebral fracture/Vertebral deformity
- Diabetes; bone loss and hip fractures. (Bone safety panels)
- Weight loss
- Endometriosis - bone loss and safety issues
- Hormone replacement therapy - bone safety monitoring
- Rheumatoid arthritis
- Alzheimer's Disease
- Multiple Sclerosis
- Osteogenesis imperfecta
- Fibrodysplasia ossificans progressive
- Prader-Willi Syndrome
- Acne. Bone mineral density in children with retinoids (Safety evaluation)
- Bone age: Greulich & Pyle, Tanner Whitehouse
- Injection depth
- Hip replacement and stress shielding
- Scaphoid fracture
- Intervertebral disc replacement