Liz Dalton Medical Imaging in Clinical Trials

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?

  1. Leverage “Collect and Hold” strategy. Avoid “Lift and Shift” where you end up changing your vendor because they cannot do central reads 
  2. 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. 
  3. 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

  1. 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
  2. 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 
  3. 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 
  4. 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  

  1. Data Integrity
  2. Data Security
  3. 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 

  1. “Rescue” studies
  2. Not getting the imaging vendor involved early in the process 
  3. Rushing to write critical documents such as the Independent Review Charter (IRC)
  4. 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

  • Static versus rotating adjudicator
  • Adjudication triggers and rates
  • Quality versus quantitative assessments

[44:08] Stakeholder relationship among site, sponsor, CRO, and imaging vendor

  • Communication
  • Transparency
  • Escalating when needed
  • Delivering results 

[46:08] Best practices for communication among imaging vendor, CROs, sponsor, and site personnel 

[47:15] Education for Sponsor and CROs

  • Determining if imaging is required or not 
  • Why are you using this modality?
  • What type of outcomes are you trying to derive from it?
  • What are you using this data for?
  • When do you need data?

[50:10] Medical Imaging Response Criteria 

[54:56] Considerations for regulatory audits

  • Audit trail including 21 CFR part 11
  • Documentation 
  • Internal audits and dedicated quality team

[56:16] Collaborating with clinical trial sites 

  • Communication is key – answer queries 
  • Site personnel should ask questions during trainings
  • Site personnel should provide feedback on vendor behavior (or lack thereof) 

[57:42] Ideal Sponsor-CRO-Imaging Vendor relationship 

  • Trusting
  • Transparency i.e. not withhold information 
  • Honesty and openness 
  • Care 
  • Mutual respect 
  • Integrity 
  • Deliver what you promised

[1:01:01] Advice for clinical research professionals 

  • Learn as much you can about different areas of clinical development
  • Pay attention to what those around you need and what they’re using the data for
  • Learn to manage up – what does your boss need to present to their boss 

[1:03:01] Interesting Conferences 

[1:07:22] ***Sponsor Message***

Calyx has been a trusted name in medical imaging for almost two decades. 

Kunal shares his own personal experience working at Perceptive Informatics (now Calyx). 

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

Resources Mentioned:

Calyx.ai central imaging partner for clinical trials  

Drug Information Association (DIA) 

SAS 

Human Genetics Resources Administration of China (HGRAC) 

Medical Imaging Response Criteria 

iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

Dr. Oliver Bohnsack

Prof.dr. D.M.F.M. van der Heijde

American Society of Clinical Oncology (ASCO)

DIA Global

Radiological Society of North America (RSNA)

Outsourcing Clinical Trials (OCT) 

Calyx Engage

Interactive Response Technologies (IRT)

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