Virtual Clinical Trials with Mike Novotny

Today we're in the midst of the pandemic and virtual clinical trials are likely going to be a big part of our post-COVID-19 world.

In this interview, I had the pleasure of speaking with Mike Novotny about virtual trials i.e. decentralized trials.

Mike is the founder and CEO of Medrio. Mikes brings over 20 years of experience in research and software to his eClinical SaaS vision.

Prior to founding Medrio, Mike was president of Ninaza, an EDC software company, and had previously held roles as a research associate at the U.N. and a manager of the fraud database at VISA.

He holds a BA from Stanford University and an MBA from Columbia University. Mike founded Medrio in 2005 in San Francisco.

I hope you enjoy my conversation with Mike.

• What is a decentralized or virtual clinical trial?
• Benefits of a virtual clinical trial in patient recruitment
• The current model of clinical trials where recruitment is done through the doctor
• What does it mean to conduct a decentralized or virtual clinical trial?
• Case Study - CNS trials and how they can benefit from going virtual
  • A limited number of patients (smaller patient pool)
  • Use of social media to find eligible patients
  • The patient does not need to travel to the doctor's office, the caregiver goes to the patients home
• Medrio as a technology provider for virtual studies
  • eConsent
  • Electronic data capture (EDC)
  • Direct Data Capture (DDC)
  • Randomization with EDC
• Case Study - Cholera vaccine study in Yemen
  • Collecting clinical data without an internet connection
  • The downside of paper data collection
• DDC is a subset of eSource
• eSource can be EHR, DDC, ePRO, eCOA
• Future of EDC as we get more integrated with EHR
• Patient recruitment
  • New efforts through AI
  • Efforts through social media
  • Genetic profiling
• Enabling participants to be anywhere in the world to participate in the trial
• Barriers to adoption
• Importance of monitoring in a virtual clinical trial to prevent fraud
• The downside of a virtual clinical trial is the implementation
  • Patients want their doctor to be involved
  • New tools lead to new complications
  • The trial does not match the decentralized model
• Common concerns from Sponsors
  • Storing data on the cloud is risky
  • Offline data management - what if the wifi goes down or there is no cellular signal
  • Data loss - what if the tablet break
• Thinking in terms of relative risk
• Clinical trials fail 90% of the time
• Trial data is never looked at again
• Need to standardize audits to bring the cost down and improving the quality of the audit
• Medrio is focused on:
  • Speed
  • Great tool for early phase diagnostic and device studies
  • Customer service measured using net promoter scores
  • eSource - Direct Data Capture (DDC)
• Optimism, focusing on the positive, not watching/ reading the news