Decentralized Clinical Trials with Derk Art

The pandemic has helped fast track the adoption of technology in clinical research.

This has been a much needed change and we’re headed in the right direction. 

The change in turn has led to an increased focus on decentralized clinical trials (DCTs). 

But what exactly is a DCT? 

To learn more, I invited Derk Arts, MD, PhD, Founder & CEO of Castor

Derk has over fifteen years of experience in medicine, research and technology. 

His company, Castor, provides useful technology for sponsors and sites to conduct decentralized clinical trials. 

What is great about Derk is that he is a physician by training and now runs a clinical trial software company. 

At a micro level, Derk understands the tools a doctor needs to provide optimal patient care in a clinical trial setting. 

At a macro level, Derk can see what it takes to conduct a clinical trial with multiple sites/ patients and how technology can solve such complex problems. 

This was a fun interview for many reasons. 

Derk talks about the future of Electronic Data Capture (EDC), his thoughts on what it means to run a decentralized clinical trial, most misunderstood aspects of DCTs, Castor’s company culture, his favorite books, honey bees, and much more. 

I hope you enjoy this conversation with the all amazing Derk Arts on the Clinical Trial Podcast. 

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Connect with Derk and Castor team

Derk Arts on LinkedIn 

Castor on social media

Being mindful of what actually improves that patient experience, what actually improves patient retention, and clinical trial timelines, and pick and choose components that make sense

Derk Arts, MD, PhD, Founder & CEO @ Castor on decentralized clinical trial technology

Show Notes

[3:59] Beyond EDC and new modalities for modern patient centric clinical trials

[5:29] Impact of decentralized clinical trials on different phases of clinical trials such as patient recruitment

[7:19] Digital technologies can increase awareness and access to clinical trials

[7:54] How to ensure population in the trial is reflective of the disease population, not just the actual population

[8:49] Advertisement campaigns or letters that take patients to landing pages where patients can enroll and screen themselves

[10:33] Enhancing patient experience with decentralized clinical trials with consumer grade quality apps for patients and simple questionnaires 

[13:42] Impact of multiple data streams on trial visibility (metrics) 

[15:21] Importance of open access and publicly available Application Programming Interface (APIs)

[17:33] Using decentralized clinical trial software for data capture (e-source) on tablets while digitizing clinical trials by removing the need for paper forms 

[20:00] Ongoing challenges with remote monitoring in a decentralized clinical trial 

  • To give people remote access to an EHR system and using web conferencing to monitor original data sources such as the EHR system, or 
  • To upload source documents

[21:44] To get the most benefit from your DCT technology, start when you design your protocol, before you go into a submission or approval process, either with the FDA or with local IRB

[23:00] Using mock trials to simulate the real world clinical trial setting 

[23:00] Some sponsors run the majority of the trial on their tried and tested infrastructure, but actually in parallel, run an arm with with some of the more mobile technology components for risk mitigation

[24:27] Using combination of a virtual site that can enroll from anywhere and traditional site that can enroll from one geographic location

[25:43] Compliance and privacy in a decentralized clinical trial model

[27:38] Tips for decentralized clinical trial technology vendor selection

  1. Look up product reviews
  2. Glassdoor rating on how the vendor is treating their employees as it generally reflects how the vendor will treat their customers
  3. Confirm regulatory compliance
  4. Speak with peers about which vendors have deployed successfully and how the vendor managed issues 
  5. References
  6. Get a live demo (not just screenshots)
  7. Is there an e-learning academy?

[34:29] Are we increasing diversity in clinical trials but reducing inclusivity or access to clinical trials by increasing the need for technology?

[36:28]   The goal should not be just to remove every single physical interaction

[37:18] Cost of technology

[40:11] Derk’s transition from being a bedside doctor to a technology founder/ CEO 

[45:01] Castor’s beehive, the Five (5) Why’s, planting trees when study goes live and more 

[48:00] Company culture and core values 

[52:39] Skills clinical research associates (CRAs) and clinical research coordinator (CRCs) need to develop with rise of decentralized clinical trials and technology 

  • Developing your mindset
  • Educating yourself with educational webinars on decentralized clinical trials 
  • Speaking to your colleagues and discussing how you can incorporate it into your standard operating procedures (SOPs)
  • Thinking about the practical implication 

[55:40] Lack of transparency around pricing on Software as a Service (SaaS) products 

[1:04:00] Current state of evidence based medicine and the future for personalized medicine using technology

Resources mentioned:

Castor on Glassdoor 

ISO 27001 Information Security Management 

General Data Protection Regulation (GDPR)

FDA 21 CFR Part 11 Electronic Records; Electronic Signatures

Interview with Craig Lipset

CVS Health

Walgreens

World Health Organization (WHO)

Solidarity clinical trial for COVID-19 treatment

Netflix CEO, Reed Hastings

Data Processing Agreement (DPA)

Business Associate Contract (Agreement)

The Knowledge Project Podcast by Shane Parrish

Goldman Sachs 

Good to Great by Jim Collins

Ego is the Enemy by Ryan Holiday

Four Hour Workweek by Timothy Ferriss

The Five Dysfunctions of a Team: A Leadership Fable by Patrick Lencioni

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