Running a rare disease study includes many challenges. It’s a more difficult patient population to access which leads to difficulties in patient recruitment, fewer medical experts available, navigation through often complex regulations, as well as potentially complex study designs. This small population makes these studies expensive as you need more sites, maybe across more countries with more time in conduct to achieve your recruitment targets – resulting in costly set-up, management and monitoring of your study.
Sponsors agree the coronavirus pandemic exposed shortcomings of existing processes in clinical trials
Modern technologies support agile processes for clinical trials 95% of attendees to our webinar this week agreed with the central message that processes and supporting technologies commonly used in clinical trials are outdated, and furthermore they contributed to the huge disruption of clinical trials caused by the COVID-19 pandemic. Systems and methods for data collection, monitoring, review and analysis have evolved in a piecemeal fashion, and whether well suited or not, are normally “bolted together”.
This was one of several deliberately thought-provoking questions raised in our webinar last month, “COVID-19: The catalyst for long overdue change in clinical trial technologies and processes”. In the first session, Gurpal Ahluwalia (Partner at BDO Life Sciences) assessed the disruptive impact of COVID-19 on clinical trials and the reasons why the industry has found itself in such difficulty. Cmed CEO, David Connelly, then shared some further perspective on the shortcomings of existing technologies and processes and suggested these contributed to the degree of disruption caused by the pandemic.
Cmed CTO: The industry has been complacent and suddenly woken up to realize their systems don’t work in a remote world
Question: Your webinar presentation earlier this week was quite provocative. Could you tell us a bit more about your background? TCC: I started writing software and building computers from scratch from a very early age. My father and I ran an educational software company when I was a teenager, and then I went on to read Engineering and Computer Science at Oxford, capping this with a DPhil in AI before co-founding Cmed Technology - a lifetime writing, designing and creating enterprise platforms with a specialism and passion for the clinical trial space.
Cmed Technology announced today the encapsia Home Visit app is now available to capture and manage clinical trial data from patients at home or in the community. The app works seamlessly with all the other encapsia apps, including web EDC (Entry app) and direct data capture (esource app) to provide tremendous flexibility in the choice of data capture methods both before and during a study. This helps maintain patient participation and clinical data flow which is particularly compelling to minimize disruption during the COVID-19 pandemic as well as in the new landscape for clinical trials that is expected to follow.
The global COVID-19 crisis has fundamentally impacted the way we live our lives as well as the operation of the entire drug development community. During the early stages of the pandemic the Cmed leadership team has implemented a number of measures to ensure the safety of our employees, clients and partners, as well as ensuring the continued delivery of our CRO services and our encapsia clinical data system. Our goal has been to minimise the impact of COVID-19 on our business, our clients, investigator sites and patients.