Beyond Traditional Clinical Trials: MEDSIR’s Adaptive Designs and Precision Medicine in Oncology
MEDSIR (Medica Scientia Innovation Research) is an international company, based in Barcelona and New Jersey, specializing in the design and management of innovative oncology clinical trials. Since its founding in 2012, MEDSIR has built a reputation for developing adaptive and precision-medicine-based trial designs, such as the PHERGain trial, which explores chemotherapy-free approaches for HER2-positive breast cancer. The company operates globally, leveraging a network of research sites and employing cutting-edge technologies, including AI, to optimize trial outcomes and reduce the burden on patients .
In light of MEDSIR's innovative approach to oncology, we sat down with Rui Rui Zhang Xiang to explore the company's approach to overcoming the challenges of clinical trials, particularly in oncology. We discussed MEDSIR's strategic focus on precision medicine, adaptive trial designs, patient engagement strategies, and their use of real-world evidence and advanced technologies. Through this interview, Rui Rui sheds light on how MEDSIR continues to push the boundaries of clinical research to improve patient outcomes worldwide.
Andrii: Oncology trials are among the most complex and demanding, especially with challenges like patient recruitment, trial timelines, and evolving regulatory requirements. From your perspective, what are the most pressing challenges in running clinical trials in oncology today, and how does MEDSIR adapt to these challenges in real-world settings?
Rui: When designing clinical trials, numerous factors must be carefully considered, including the unmet needs of patients, the competitive landscape, and the current standard of care, among others. It is a highly complex process that requires seamless collaboration across multidisciplinary teams to assess these elements and ensure the successful execution of the trial.
At MEDSIR, our various divisions work closely together to ensure that our clinical trial strategies are meticulously planned and executed. One of our key strengths is the strong interdepartmental collaboration and integration we foster. Our multidisciplinary and international team, which includes professionals from over 13 different nationalities with extensive expertise in clinical development, operational, translational research and regulatory, allows us to adapt swiftly to different regions and efficiently address any gaps or challenges taking into consideration every aspect along the way of the trial execution. This diverse expertise not only strengthens our approach but also enables us to better navigate the complexities of clinical trials across various territories.
Andrii: With MEDSIR’s strong focus on precision medicine and innovative clinical trial designs, can you elaborate on how your team incorporates adaptive trial designs and precision medicine into clinical research? Additionally, how do you navigate the complexities of biomarker-driven trials while ensuring compliance with regulatory standards in regions like Europe and Latin America?
Rui: We are a company that thrives on innovative, out-of-the-box solutions to streamline timelines and achieve our goal: improving patients' quality of life and providing better treatment options. Our efforts are focused on optimizing clinical trial designs to deliver impactful and meaningful results.
A prime example is our PHERGain trial, which explores a chemotherapy-free treatment regimen while maintaining the pathological complete response (pCR) rate, comparable to the standard of care. This trial uses an innovative adaptive design to de-escalate treatment without compromising patient outcomes. The exceptional results from PHERGain have enabled us to further investigate this patient population, allowing us to better identify those who could benefit from a chemotherapy-free approach by analyzing samples with advanced platforms like HER2DX®.
Andrii: Given MEDSIR’s collaborative approach with biotech and pharmaceutical companies, how does your team specifically support these companies in developing novel cancer therapies?
Rui: We understand that every company has its own strategy and specific resources. That’s why we have developed a model that offers tailored solutions with strategic services customized to meet the unique needs of each organization at every stage of the process. This approach guarantees a distinctive level of support and collaboration throughout.
MEDSIR has a disruptive model that combines the best perks of company-sponsored and academia research bringing the flexibility to unlock the full potential of each client's unique assets, fostering sustainable growth and securing long-term success in an increasingly competitive market.
Andrii: As real-world evidence and technology become more integral to clinical trials, how is MEDSIR leveraging advanced tools such as artificial intelligence and machine learning to optimize trial outcomes?
Rui: MEDSIR is a fully digitalized company, always adapting to the latest global changes. We not only utilize our own advanced monitoring tools, but we also stay at the forefront of cutting-edge technologies, including the use of synthetic arms for sampling and AI-driven studies, such as the EU-funded I3LUNG project.
We understand that time matters in clinical development and our mission is to bring the best options to patients. Therefore, we work every day to integrate the latest global innovations into our solutions for clients.
Andrii: Oncology trials face unique challenges with patient engagement and retention, particularly in advanced disease stages. What patient-centered strategies does MEDSIR implement to improve recruitment and retention in oncology clinical trials? Additionally, how does MEDSIR collaborate with patient advocacy groups to ensure that trials align with both clinical endpoints and patient needs, particularly in improving their quality of life?
Rui: Our company is led by KOLs with a strong commitment to driving impactful clinical research that enhances patients' quality of life through the effective development of innovative therapies. We work closely with researchers to understand real patient needs and collaborate with patient associations and foundations, such as the Metastatic Breast Cancer Association in Europe and Susan G. Komen for the Cure in the U.S., to ensure our trials are align with both clinical endpoints and patient priorities.
Our strategies are tailored to the specific realities of local healthcare systems, and we believe patient empowerment is essential to improving outcomes. We implement patient-centered strategies that enhance engagement and retention including personalized support, collaborations with advocacy groups to integrate patient feedback, close site engagement, local understanding of the clinical practice and leveraging cutting-edge technologies to reduce the burden on participants.
Through these efforts, we aim to ensure that our clinical trials not only meet scientific goals but also improve patients' quality of life.
Andrii: MEDSIR operates across multiple regions, including Europe and Latin America, which requires expertise in navigating diverse regulatory environments. How does your team handle the operational complexities of running multicenter oncology trials across different countries and regulatory frameworks? Could you share insights on any specific regulatory or logistical challenges you've faced and how MEDSIR has addressed them in recent trials?
Rui: Successfully conducting multicenter oncology trials across different countries requires a deep understanding of the diverse regulatory environments and local clinical practices. At MEDSIR, we place significant emphasis on thoroughly understanding the procedures of each regulatory agency, as this knowledge is essential for making accurate time estimates and assessing the impact on clinical trial development. We ensure compliance with local regulations, allowing us to optimize timelines by defining the proper regulatory strategy for smoother execution of the trials.
Additionally, we collaborate with local stakeholders in every region, which strengthens our network and enhances operational efficiency. These partnerships are key to overcoming regulatory and logistical challenges that require this level of regional collaboration and in-depth knowledge of local procedures, allowing us to run trials more effectively across multiple regions.
Andrii: As MEDSIR prepares to participate in the 21st Biopharma Clinical Trials Nexus on October 22nd and 23rd, 2024, alongside BiopharmaTrend, what are your main goals for this conference?
Rui: Our primary goals for the conference are to expand our network of collaborators and engage in meaningful discussions with industry leaders. We are particularly interested in exploring new operational approaches and learning from innovative models in the field. Additionally, we aim to showcase our unique approach to offering alternative solutions in clinical trials, demonstrating how our tailored strategies can drive more effective development and patient-centered outcomes.
At MEDSIR we connect, innovate and advance.
