I think that COVID-19 will be the death knell for on-site monitoring visits and SDV. Predictions for 2020 and the next generation of clinical research – mobile EDC for sites, patients and device integration that just works.
I’m neither a clinical quality nor a management consultant. I cannot tell a CRO not to bill out hours for SDV and CRA travel and impact study budget by 25-30% and delay results by 12-18 months.
Nope. I’m not gonna tell CROs what to do. Darwin will do that for me.
I develop and support technology to help life science companies go faster to market. I want to save lives by shortening time to complete clinical trials for COVID-19 vaccine and treatments by 3-6 months.
I want to provide open access to research results – for tomorrow’s pandemic.
I want to enable real-time data sharing.
I want to enable participants in the battle with COVID-19 to share real-world / placebo arm data, making the fight with COVID-19 more efficient and collaborative and lay the infrastructure for the next wave of pandemics.
I want to provide real-time data collection for hospitals, patients and devices. Use AI-driven detection of protocol violations and automated response to enable researchers to dramatically improve data reliability, allowing better decision making and improving patient safety.
The FDA (a US government regulatory bureaucracy) told the clinical trial industry to use e-Source 10 years ago and to use modern IT . If FDA couldn’t then maybe survival of the fittest and COVID-19 well do the job.
FDA’s Guidance for Industry: Electronic Source Data in Clinical Investigations, says, in part:
“Many data elements (e.g., blood pressure, weight, temperature, pill count, resolution of a symptom or sign) in a clinical investigation can be obtained at a study visit and can be entered directly into the eCRF by an authorized data originator. This direct entry of data can eliminate errors by not using a paper transcription step before entry into the eCRF. For these data elements, the eCRF is the source. If a paper transcription step is used, then the paper documentation should be retained and made available for FDA inspection.”
I loved this post by Takoda Roland on the elephant in the room.
Source data validation can easily account for more than 80% of a monitor’s time. You go on site (or get a file via Dropbox). Then you need to page through hundreds of pages of source documents to ensure nothing is missing or incomplete. Make sure you check the bare minimum amount of data before you need to rush off to catch my flight, only to do it all again tomorrow in another city, I am struck with this thought: I love being a CRA, but the role as it exists today is obsolete.