Moving Drug Development Forward Through a Focus on Clinical Outcome Assessments: Koneksa at Recent Critical-Path Institute Meetings

Last week, two important events happened, both hosted by the Critical Path Institute (C-Path): the Electronic Clinical Outcome Assessment (eCOA) Consortium meeting on April 16, and the 2024 Clinical Outcome Assessment (COA)  Program Annual Meeting on April 17-18. Koneksa had the privilege of participating in both, and presenting at the latter. 

The latter – the COA program meeting – is a pivotal gathering for scientific and operations experts from pharmaceutical sponsors, technology vendors, and the FDA. This event is a public gathering that provides a collaborative and pre-competitive platform where industry leaders converge to discuss and shape the future of COAs and digital health technologies (DHTs) in clinical trials. It sets the stage for aligning the latest scientific advancements of regulatory science  and exploring new ways to integrate technologies in clinical trials, thereby influencing the development and delivery of innovative treatments. Held over two days in the Washington, DC area, the event provided a rich forum for discussing the evolving landscape of the patient voice in clinical trials.

One of the highlights for Koneksa was the session co-presented by our Chief Scientific Officer, Dr. Elena Izmailova. The topic was "eCOA and DHTs in Oncology: Realizing the Digital Dividend," and she shared her perspective on, and experience with, an n=1 study that incorporated digital tools for objective data collection in conjunction with a diary approach. Her session underscored the importance of incorporating DHTs to complement traditional self-report data collection. A theme emerged, in this session and in the meeting overall: DHTs can enhance the accuracy and efficiency of clinical outcomes, and this ability is crucial for advancing patient-centered research and drug development.

Participating in this conference allowed Koneksa to not only showcase our unique positioning in the industry, but also to better understand the FDA's current expectations as well as the industry’s latest COA strategies. Interactions with FDA officials and industry peers provided invaluable insight into regulatory trends and patient-focused drug development, guiding our strategies for future projects. Notably, discussions on leveraging DHT for measuring clinical outcomes could directly benefit our ongoing and future projects by enhancing our data collection and analysis frameworks.

The eCOA Consortium annual meeting was similarly important. This all-day conference is a gathering for Consortium members only, and highlights a strategic imperative for a collaborative space  where the best industry practices are being developed.  The members interrogated and strategized extensively on all matters of eCOA & DHT platforms, ranging from scientific insights to challenges of deployment. These discussions enrich understanding of industry trends and help collectively advance DHTs in clinical trials and research, addressing current challenges and forging the path for future applications. The knowledge and connections gained are steps forward in our mission to harness technology for better measures and health outcomes. 

As the healthcare landscape evolves, Koneksa remains at the forefront, driven by data and digital innovation to improve patient care and treatment efficacy.