Koneksa recently participated in two milestone gatherings in the digital health community. Let’s talk about what they were and why they matter!
The first was the first meeting of the eCOA Consortium. This group comprises organizations like Koneksa that work on electronic clinical outcome assessments (eCOA). Its goals are to develop best practices, to share experiences and challenges, and to educate study sponsors on how to deploy eCOA efficiently and on par with standard industry practices. The eCOA Consortium also publishes papers sharing members’ experiences and their perspectives on the challenges and solutions of the field (reference, reference). Elena Izmailova, Koneksa’s Chief Scientific Officer, said, “Face-to-face meetings always provide a priceless experience of being able to share thoughts and challenges, and brainstorm solutions. This meeting was no exception. It was wonderful to see everyone and discuss our field’s most pertinent challenges, including the deployment of wearable sensors for data collection in clinical trials.”
The second recent event of this kind was the first annual public PRO Consortium workshop since the beginning of the pandemic. The meeting is organized by the Critical Path Institute, a public-private partnership, and the ePRO Consortium. Elena said, “There were multiple outstanding presentations, including updates from the FDA about the eCOA qualification program, real-life examples of approvals using novel methodological approaches and eCOA instruments, and the upcoming 4th FDA guidance on patient-focused drug development and methodological approaches, which will be presented at the public meeting. It’s always illuminating to hear from people who live with a particular condition, and to learn how partnerships between patients and sponsors bring new insights into disease pathophysiology, and assessment of disease severity and progression. One example we heard at the workshop was about how the partnership with a patient-advocacy organization brought dupilumab to patients with the rare condition eosinophilic fasciitis. Also, we discussed where challenges can be addressed to improve the lives of people with chronic diseases.”
As committed members of the digital health technology community advancing digitally derived measures and biomarkers to facilitate drug development and bring much-needed treatment to patients, we at Koneksa find events like these important for us and our collaborators. We are committed to advancing clinical trials by providing scientific expertise and in-depth knowledge of both technologies and development processes to accelerate the development and approval of novel treatments. Working together as a community, our work can help many people live longer, healthier, more productive lives.