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One2Treat, a new innovative start-up offering cutting edge digital health solutions, launches with a pioneering approach that addresses two of the most strategic challenges in the biopharma industry today – incorporating multiple outcomes that matter to patients into a single holistic treatment assessment while accelerating the delivery of new treatments to market. This method, refined through years of research and practical applications, not only enables a more patient-centric approach but also leads to consistent (often drastic) reductions in trial design sample sizes and time to market.
In today’s clinical studies, the focus on one or two primary endpoints often leads to underutilization of valuable data and fails to capture the holistic impact of treatments on patients. Moreover, if the primary endpoints are not met, the trial is considered “negative” regardless of any treatment benefits on other endpoints. Even when a trial is successful, many of the potential insights may be ignored. More importantly, the primary endpoints often fail to reflect what matters to patients, for instance in terms of quality of life.
One2Treat offers a revolutionary approach to clinical trial design and analysis, focused on incorporating all key patient-relevant outcomes into the primary analysis. This paradigm shift draws from extensive industry experience and a rigorous methodology – developed and tested across numerous sponsors’ projects within its parent company IDDI.
At the core of One2Treat’s offering lies a unique blend of statistical methodology, software, and expert clinical insights. One2Treat’s proprietary software incorporates the groundbreaking Generalized Pairwise Comparisons (GPC) methodology, allowing non-statisticians to leverage sophisticated statistical techniques with ease. This innovative approach enables sponsors to conduct more patient-centric treatment analysis, by including multiple outcomes in a mathematically rigorous assessment and paving the way for treatments that truly align with patient needs.
Marc Buyse, One2Treat Founder, speaking at the launch of One2Treat, underscored the need for a paradigm shift, stating: “Traditional models often neglect critical aspects of patient well-being, such as quality of life, which can significantly influence treatment effectiveness. Therefore, standard primary endpoints only partially capture patients’ concerns. One2Treat addresses this gap by enabling sponsors to listen to patients’ preferences and evaluate treatment effects across multiple dimensions, within a single reliable assessment. Moreover, leveraging a higher percentage of the collected study data allows for a higher statistical significance and/or a reduced sample size.”
Sebastien Coppe, CEO of One2Treat, affirms the company’s commitment to revolutionizing clinical research practices, stating: “Advancements in computing power and a growing focus on patient-centricity present an opportunity for transformative change in the industry. One2Treat’s innovative approach not only enhances trial design and analysis but also facilitates a more transparent and efficient transition from drug development to market access. Leveraging the same rigorous method to analyze data about overall treatment effects enables us to connect the dots between these two critical elements of global healthcare. Indeed, One2Treat’s unique solution provides a comprehensive benefit-risk evaluation of the treatment based on what matters most to patients (e.g., considering both efficacy and safety outcomes within a single assessment)”.
As One2Treat emerges to disrupt the status quo in both clinical research and HTA/market access, its vision transcends traditional stakeholders to include clinicians and patients themselves. Through its dedicated solution, One2Treat aims to empower individuals to voice their treatment preferences and access personalized care tailored to their unique specific needs.
