Medical Imaging in Clinical Trials with Elizabeth Dalton

In this episode, I’m excited to talk about medical imaging in clinical trials.

We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process, and more.

The guest for today’s show is a long time friend of mine, Elizabeth Hartunian Dalton, Vice President at Calyx.

Liz is a seasoned clinical trial professional with 17+ years of experience working with sponsors, sites, and CROs in centralized medical imaging and clinical trials.

Driven by a passion for service, Liz’s ethos is rooted in honesty, productivity, commitment, and the power of positive energy.

In addition to her primary role of growing the Calyx partnership/CRO channel, Liz leads a team of technical solution consultants and is a medical imaging consultant herself.

Liz attended the University of Massachusetts where she achieved dual Bachelor degrees in Anthropology and Economics (magna cum laude) and will graduate in May 2023 with her MBA from Boston University’s Questrom School of Business.

Please join me in welcoming Liz on the Clinical Trial Podcast.

At the end of the day, the one thing that people are buying is the data, they want the data that can pass regulatory scrutiny that shows them if their data is up to snuff – Elizabeth Dalton (Click to Tweet)

Sponsor:

This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

Show Notes:

[4:02] Role of medical imaging in clinical trials

Serves as a surrogate endpoint
Measures safety and effectiveness

[6:35] Types of studies with medical imaging endpoints

Oncology
Central Nervous System (CNS)
Alzheimer’s Disease (AD)
Multiple Sclerosis (MS)
Musculoskeletal
Endocrine
Women’s Health

[7:42] Imaging modalities across different trials

CNS trials → PET or MRI
Women’s Health trials → Ultrasound or DEXA scan
Oncology trials → CT, MRI, bone scan, brain scan
Gastro Intestinal (GI) trials → Endoscopy

[8:41] What to expect when you work with a centralized medical imaging partner?

Meet with the scientist to review the protocol. The goal is to understand what is needed from the quality and scientific perspective
Determine if imaging reads are needed
- If yes, decide between (a) Full service or (b) “collect and hold” method with quality control
Quality control and endpoint assessment
- Mixed – manual and Artificial Intelligence (AI) quality control
- AI to review metadata
- FDA requires a qualified physician to perform the final imaging endpoint assessment
- Medical QC to identify outliers
Data Export in SAS format

[14:48] Rolling reads are preferred when the protocol requires blinded independent central review (BICR)

[19:33] 90% of the scans come in electronically, sometimes hard copy films but that is usually the exception

[22:34] What are some ways to save money on medical imaging services?

Leverage “Collect and Hold” strategy. Avoid “Lift and Shift” where you end up changing your vendor because they cannot do central reads
Be mindful that imaging is your endpoint and involve the imaging vendor early in the process during protocol development. This helps reduce the number of protocol amendments, reduces confusion with the sites, and patients.
Think beyond the trial. Sponsor is able to provide about future business and how to be efficient

[26:20] Taking care of patients and sites – how not to be annoying imaging lab

You don’t want to scan a patient twice (extra radiation, time, etc.). Clear guidelines to ensure that you’re going to get quality and training of each site in an efficient way is the key
Setting up systems that are easy for site personnel i.e. study coordinator, site radiology, site imaging technologist. Example, not require imaging transmittal form with each piece of imaging data
Identifying satellite facilities for patients that are not close to the main site. This allows the patient to complete their study visit easily at local imaging facility
Providing expedited feedback (real time results) to the sites such as a confirmation that patient has progress or a safety alert

[30:17] Importance of staying close to clinical practice when developing a centralized imaging protocol/ performing decentralized clinical trials

[31:54] Cybersecurity considerations for central imaging vendors

Data Integrity
Data Security
Data Warehousing

Experience of the user is generally NOT fully parsed out

[34:26] Country and site selection for quality medical imaging data

[35:23] Cultural differences between US and Asian countries

[35:52] Expensive mistakes sponsors make with medical imaging projects

“Rescue” studies
Not getting the imaging vendor involved early in the process
Rushing to write critical documents such as the Independent Review Charter (IRC)
Picking the right vendor

[38:43] ***Sponsor Message***

Calyx is a trusted name in medical imaging.

Calyx’s experience includes over 2,600 clinical trials and 270 FDA supported approvals and spans multiple therapeutic areas, with significant concentration in oncology and CNS-related drug development across all phases, geographic areas, and degrees of complexity.

To learn more about how Calyx can help you with your imaging needs, visit calyx.ai or contact your Calyx solutions specialist today.

[40:25] Factors impacting adjudication of medical imaging data