How one company is incorporating patient perspectives in clinical trials

One2Treat aims to make the clinical trial process as seamless as possible and answered a number of the questions we put to Samuel Salvaggio who bridges clinical insights with biostatistics.

Patient Engagement: How do you involve patients in the design and execution of your clinical trials? ​

We place a strong emphasis on incorporating patient perspectives in the clinical trials we design. We achieve this by using our innovative statistical methodology which allow to include multiple key outcomes in a single comprehensive assessment, ensuring a holistic evaluation of the treatment's impact. This patient-centric approach can involve actively seeking and integrating feedback from patients and patient advocacy groups during the design phase. By prioritizing patient-relevant outcomes and considering their needs and preferences, we ensure that our trials not only assess efficacy and safety but also focus on improving patients' quality of life.

Innovation and Technology: Are there any new technologies or methodologies you are implementing to improve the efficiency and accuracy of your clinical trials and how is your company using data analytics or AI to enhance clinical trial processes? ​

We are at the forefront of integrating advanced technologies and innovative statistical methodologies to revolutionize clinical trials. Our approach enhances the patient-centricity of clinical trials by incorporating multiple key outcomes into a single comprehensive analysis, providing a more nuanced understanding of treatment effects. This holistic assessment not only increases the clinical relevance of our analyses but also significantly reduces sample sizes, improving overall trial timelines and accelerating its time to market.

Our cutting-edge software leverages AI-driven algorithms to identify patterns and trends in previous trial data, optimizing future trial design and execution. By utilizing advanced data analytics and artificial intelligence, our innovative SaaS solutions integrate powerful computing capabilities to analyze vast volumes of clinical data, providing deeper insights and more robust statistical power. By enabling a more patient-centric trial design, we ensure that the different facets of therapy are evaluated comprehensively, reflecting the true benefits and risks based on what matters most to patients.

Regulatory Compliance: How do you ensure compliance with global regulatory standards during your clinical trials?  Have there been any recent changes in regulations that have impacted your clinical trial operations? ​

We follow closely guidelines set forth by major regulatory agencies such as the FDA, EMA, and other international bodies. Additionally, our software is designed to meet stringent standards, ensuring that our trial designs, and analysis processes are robust, transparent, and align with global regulatory expectations. Regulatory bodies put an increasing emphasis on patient-centric approaches and the use of innovative methodologies that integrate reported outcomes. This shift aligns well with our solution, which facilitate a more comprehensive assessment of treatment effects. Adapting to these regulatory changes, we have enhanced our trial designs to incorporate these broader evaluation criteria, ensuring our trials not only comply with the latest standards but also prioritize patient well-being and clinical relevance.

Future Goals: What are your company’s long-term goals for clinical trial development and innovation? ​

One2Treat’s long-term goals for clinical trial development and innovation are centered around enhancing patient-centricity and optimizing trial efficiency. We aim to revolutionize clinical trial designs by integrating multiple outcomes into a single aggregated measure. This approach can not only estimate the net benefit of treatments but also improves the clinical relevance of trials while minimizing their sample sizes, potentially by up to 20%. We are committed to leveraging advances in computing power and data analytics to implement these innovative methodologies, ensuring that trials are more reflective of patient needs and preferences. By continually investing in software development and engaging with patients and stakeholders, we strive to set new standards in clinical research, ultimately accelerating the development of new therapies and improving patient outcomes.

How do you envision the landscape of clinical trials evolving in the next five to 10 years? ​

In the next 5 to 10 years, we envision the landscape of clinical trials evolving towards more patient-driven and technologically advanced clinical trial assessments. The focus will shift from traditional single primary endpoints assessment to more holistic evaluation of treatment benefits, better reflecting the treatment impact on patients' lives. Additionally, increased patient engagement and reflecting their preference elicitation will ensure that clinical trials are designed with the patient's voice at the forefront, leading to more relevant treatments. As the industry embraces these changes, we anticipate a significant acceleration in the time to market for new therapies, better alignment with patient needs, and overall improvements in the efficiency and effectiveness of clinical research.