Today we’re in the midst of a 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, CEO of Medrio, a company that provides eClinical solutions for clinical research.
Mike is the founder and CEO of Medrio. Mikes brings over 20 years of experience in research and software to his eClinical SaaS vision.
One of the confusing parts of virtual trials, what does “virtual” actually mean and what tools are needed to conduct such a trial.
A few big value propositions for going virtual include reducing inefficiencies in patient recruitment i.e. taking the trial to the patient home, reduced monitoring, and ability to do more with work remotely.
New technology breeds new challenges and unanticipated complexities and virtual trials are no exception.
Mike and I discuss this all and more.
Mike Novotny on LinkedIn
[01:50] What is a decentralized or virtual clinical trial?
[02:48] Benefits of a virtual clinical trial in patient recruitment
[03:40] The current model of clinical trials where recruitment is done through the doctor
[04:48] What does it mean to conduct a decentralized or virtual clinical trial?
[06:25] Case Study – CNS trials and how they can benefit from going virtual
[08:37] Medrio as a technology provider for virtual studies
[10:25] Case Study – Cholera vaccine study in Yemen
[13:11] DDC is a subset of eSource
[13:20] eSource can be EHR, DDC, ePRO, eCOA
[15:17] Future of EDC as we get more integrated with EHR
[17:33] Patient recruitment
[21:30] Enabling participants to be anywhere in the world to participate in the trial
[23:20] Barriers to adoption
[30:00] Importance of monitoring in a virtual clinical trial to prevent fraud
[37:00] The downside of a virtual clinical trial is the implementation
[39:40] Common concerns from Sponsors
[41:12] Thinking in terms of relative risk
[45:22] Clinical trials fail 90% of the time
[46:00] Trial data is never looked at again
[47:57] Need to standardize audits to bring the cost down and improving the quality of the audit
[53:33] Medrio is focused on:
[58:00] Optimism, focusing on the positive, not watching/ reading the news