Clinical Trial Readiness

One of the biggest challenges in clinical study start-up and conduct is “training.”

A few factors that impact training include the clinical site personnel’s ability to retain and understand key study information, staff turnover at the site, individual learning style and preferences and much more. 

With many clinical research and trial activities going virtual, having an online platform to train research staff on the protocol and trial operations is useful and necessary.

In this podcast interview, I speak with Joel Selzer, CEO & co-founder of ArcheMedx.

Joel shares with us how the ArcheMedx team is using technology and behavioral science to improve clinical trial operations with a focus on study training.

We also discuss the importance of adequately preparing sites and site personnel to conduct a clinical study, how sponsors and CROs can effectively deliver study content and much more.

I hope you enjoy my conversation with Joel on Clinical Trial Readiness.

Joel Selzer on Twitter and LinkedIn

Joel’s email address is joel@archemedyx.com

Sponsor

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Show Notes

[4:52] What is Clinical Trial Readiness?

  • Which coordinators, CRA, investigators are adequately prepared to conduct their study?
  • Where do they have strength? Who are going to be their top performers? 
  • Where do they have potential risk that can be more effectively mitigated ahead of time?

[6:04] ArcheMedx helps CROs and Sponsors to effectively deliver their study content

[9:08] Analyze and assess the relative capabilities of each site, qualitatively and quantitatively in a standardized way 

  • Understand what sites skipped over, didn’t pay any attention, or struggled in one particular area versus another 
  • Sponsor or CRO map clinical study content to key objectives
  • Behavioral data combined with the correctness and confidence over time to create a predictive model
  • Predictive model informs clinical operations at different points of the study about where they need to focus their time and attention around the site or a CRA, who may or may not be prepared
  • Clinical operations can then modify their approach to run more efficiently in a virtual environment

[14:39] Setting up your clinical research project using ArcheMedx platform

  • To get started, you need to upload your protocol, dosing guidelines, Site Initiation Visit (SIV) deck, and other supporting documents into the ArcheMedx platform
  • Know where you want your sites and CRA to focus their attention and what you want to measure

[17:09] Sites are managing multiple studies, it is easy to get confused or to misunderstand information. How to leverage technology to decrease protocol deviations and increase protocol compliance? How to increase knowledge and competence of the site PI, CRA, CRC, and other research personnel?

[24:46] Joel recommends reaching out to a potential PI or sub-I for a 10-15 minute phone call. You’ll gain behavioral insights that can you use to guide your site selection decisions

[27:14] Using ArcheMedyx to evaluate whether or not a site has the capability and interest to perform the study 

[28:12] Natural evolution of digital comfort is helping adoption of technology in clinical research, especially now due to COVID 

[32:58] The biggest impediment to using any other virtual tool is inertia. The pandemic is serving as a catalyst, to infuse an opportunity to transform clinical operations, particularly around study startup

[30:27] Improving patient recruitment and retention by communicating best practices 

  • Harness the lessons learned from early sites, and then rapidly provide those insights to subsequent sites
  • Identify key pieces of information and insights being learned and letting the platform automate the delivery of that information out to each target site at the appropriate point of time

[36:24] Increasing patient awareness and education around a clinical trial

  • Patients have many questions before they’re going to enter a study
  • Physicians have very little time to answer those questions in a face to face interaction, even if it’s over Zoom or telephone today
  • Reducing the cognitive load and challenge for a patient to more effectively understand how that study benefits them, what the risks are, and moving them through the consent process more efficiently

[40:45] ArcheMedx as a continuing education platform serving the medical community 

[41:56] Why clinical leaders are seeking virtual solutions to connect with PIs and sub-I? (hint: we cannot fly to Barcelona right now for an Investigator Meeting :)) 

[44:06] Financial savings and resource efficiency for organizations in the following ways:

  • Managers no longer need to spend one-on-one, non-billable time to evaluate and explain topics such as confidentiality or patient safety to their staff. Savings of $150,000+ per competency area
  • The platform can be set to an extremely high threshold for demonstration of confidence and mastery around a topic. A CRA can unequivocally demonstrates that they are capable in a specific area. This ultimately leads to savings in time and travel costs

[50:34] Increasing level of collaboration across the industry

Resources mentioned:

Adobe Captivate

FDA’s Guidance on Conducting Studies During COVID-19 

Understanding the FDA’s Guidance on Conducting Studies During COVID-19 (courtesy: Archemedx)

Fierce Pharma

Fierece Biotech

ISR Reports 

[Book] The Goal: A Process of Ongoing Improvement

People mentioned:

Kelly Ritch

 

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