Paul O'Donohoe’s Post

eCOA Libraries are something I know all my friends and colleagues in the eCOA world have spent time wrestling with. We need to be transparent about the challenges involved in meaningfully implementing libraries to truly unlock the potential I think we all agree they hold. Collaboration is a key step on this path - to that end, it was a pleasure collaborating with Ines Smajic on this article. I don't know anyone with more experience navigating the complexity of implementing copyright measures in clinical research. Read the below to learn more. #ClinicalResearch #LifeSciences #Medidata

Delighted to see this important publication getting out there. Our industry leans a lot on the idea of best practices for implementing eCOAs as a way of ensuring data integrity and a good patient experience. This is the first attempt at a truly consensus summary of those best practices. Florence Mowlem, PhD expertly (and patiently!) herded an amazing team of friends and colleagues. As always it was a pleasure, and an important opportunity for me to have my own opinions on these things challenged. I look forward to the discussion this triggers as we continue to improve how we’re using these technologies to better understand the patient experience in clinical research. Onwards!

Scottie Kern, Farrell Healion, Bryan McDowell and myself will be discussing the apparently perennial topic of BYOD on Wednesday at SCOPE Europe - there’s always a lot of interest and questions around this topic so hopefully the unfeasibly long combined eCOA experience the panel has can provide some useful insights. I hope to catch up with some of you there!

This is big, so good to see years of work come to fruition. I'll have much more to say on this in the coming weeks, but for now I'll just quote our concluding sentence of the report which nicely frames my optimism that we're entering a new era of technology-driven clinical research: "As the question of comparability loses some of its urgency and can be increasingly considered an “answered question,” our hope is that the focus of eCOA research can shift toward taking full advantage of the power of these technologies to provide insight into the patient experience in clinical trials, rather than being unnecessarily occupied with creating screen-based simulations of paper formats." Much love and respect to my co-authors, David Reasner, Sarrit Kovacs, Bill Byrom, Sonya Eremenco, Alexandra I Barsdorf, PhD, Valdo Arnera and Stephen Joel Coons - together we wrestled with these complex ideas and kept each other intellectually rigorous. The final product is so much more than the sum of our individual contributions. Huge thanks are also due to Elizabeth Molsen-David who helped us actually get this over the finish line, as well as countless wonderful friends and colleagues across the industry who provided invaluable feedback along the way. Onwards!

Hoping to see many of you in Gothenburg next week, looking forward to talking beyond just eCOA and exploring how we “e” the entire clinical data lifecycle.

Would you like to help build the future of eCOA and patient clinical technology? Come join my team!

This is a major milestone for the Patient Cloud team at Medidata, and I'm so excited it's finally out there in the wild. I'm also super proud of the team - Kris Chua, Amy Huynh, Michael Lange, PMP and the literal scores of others - all of who worked so hard to bring this to fruition. Amazing work. And it's only the start. So much cool stuff coming next year - watch this space!

This was a stimulating event in Paris, many thanks to DMB for hosting. It was encouraging and exciting to hear friends and colleagues consistently echo the message that we have been decentralising trials for years now (what else is eCOA but a decentralisation tool?), and that sooner rather than later we'll stop talking about "decentralised clinical trials" as being their own unique thing and go back to talking about clinical trials and how best to use technology to support patients and the study design to achieve success.

Looking forward to seeing some of you at this tomorrow!