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In this new role, Dr. Piedbois will ensure the One2Treat suite of offerings are developed and delivered with the requirements of both patients, and our customer’s clinical teams, front and center. 

One2Treat’s innovative approach, driven by its Founder Marc Buyse, aims to reduce trial sample sizes and accelerate patient access to new treatments. This is achieved by incorporating multiple clinical outcomes that matter to the patient as early as the study design through robust statistical methodologies. Dr. Pascal Piedbois will be a key driver in this endeavor.

Dr. Pascal Piedbois, Prof. of Medical Oncology, brings over 30 years of clinical development experience in both academia and industry, holding positions including Head of Medical Oncology at Paris University, General Director of the Comprehensive Cancer Center of Alsace Region, and several leadership roles in the pharmaceutical industry, including Vice President, Head of Global Oncology and Infectious Diseases at AstraZeneca, Senior Vice President, Medical Head Major Markets at Bristol Myers Squibb and General Manager at Boehringer-Ingelheim Belgium. 

“Pascal’s extensive medical experience will address one of the most strategic challenges in the biopharma industry today: incorporating multiple patient-relevant outcomes into a single holistic treatment assessment,” said Sebastien Coppe, CEO of One2Treat. “Pascal’s deep industry knowledge will ensure that our innovative solutions bring clinically meaningful transformations in the way we design clinical trials and handle key market-access questions, such as benefit-risk analyses. In today’s clinical studies, focusing on one or two primary endpoints often leads to underutilization of valuable data and fails to capture the holistic impact of treatments on patients.”

Dr. Pascal Piedbois adds: “There is a huge opportunity to involve patients, sponsors, regulatory agencies, and payers early in the clinical trial design process. By aligning on their specific needs and prespecifying the primary endpoint of the registration study, we can run more efficient trials and bring new treatments to market faster. This approach will ensure that clinical trials are more reflective of what truly matters to patients, including quality of life for instance.” 

Marc Buyse, Founder of One2Treat, highlights the need for a more patient-centric approach in clinical research: “I am delighted that Pascal, with whom I have had a long and very fruitful collaboration, joins One2Treat today. His medical expertise will speed up the implementation of this multi-dimensional approach, ensuring our message resonates with medical leaders.” 

Dr. Pascal Piedbois concludes: “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. Using a rigorous, quantitative method to analyze overall treatment effects allows us to connect clinical research and health technology (HTA) assessment seamlessly, providing a comprehensive benefit-risk assessment based on what matters most to patients.” 

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 software solution, One2Treat aims to empower individuals to voice their treatment preferences and access personalized care tailored to their unique specific needs.  

https://www.prnewswire.com/news-releases/pascal-piedbois-md-phd-joins-one2treat-as-chief-medical-officer-to-advance-patient-centric-innovation-in-clinical-trial-design-and-market-access-302192051.html

Reflecting on the recent Society for Clinical Trials (SCT) Annual Meeting in Boston, it is evident that patient-centricity was at the forefront of discussions. Its theme, “It Takes a Village: Patient-Centered Partnerships in Clinical Trials“, resonated deeply throughout the conference, emphasizing the critical need to increase patient involvement in clinical research.

Patient-centricity is not just a buzzword; it’s a fundamental shift in clinical trial approach. The conference featured numerous sessions that challenged the status quo, advocating for the genuine incorporation of patient perspectives from trial design through execution. The program highlighted targeted sessions showcasing innovative solutions to shape more effective and relevant research with patient input.

While it’s vital to discuss patient-centricity, the focus must be on actionable steps. One standout initiative from the conference was the multiple sessions on Generalized Pairwise Comparisons (GPC) methodology, including one of its specific applied case: the Desirability of Outcome Ranking (DOOR). These innovative statistical approaches allow for the inclusion of multiple key outcomes into a single comprehensive assessment. By allowing the evaluation of efficacy, safety, and other relevant factors together, GPC provides a holistic view of a treatment’s impact, aligning with patient priorities and improving the understanding of trial results.

The SCT Annual Meeting underscored the critical role of patient-centered approaches in the future of clinical research. By embracing methodologies like GPC and actively involving patients from the design phase, we can ensure that clinical trials not only meet regulatory standards but also improve patient outcomes. As we move forward, the insights and collaborations from this conference will guide us in driving innovation and setting new standards in clinical research.

At One2Treat, we are committed to advancing patient-centric clinical trials through the implementation of GPC. This methodology not only enhances the clinical relevance of our assessments but can also prioritize patient needs and experiences, making trials more meaningful and patient-centered.

Our colleague, Samuel Salvaggio, was interviewed by Outsourcing Pharma:

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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 analyse 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’slong-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 5 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.

 Read the full article on Outsourcing-Pharma 

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