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FDA establishes Center for Clinical Trial Innovation


FDA establishes Center for Clinical Trial Innovation

We're thrilled to celebrate a milestone in clinical trial innovation with the unveiling of the FDA's Center for Clinical Trial Innovation (C3TI) by the Center for Drug Evaluation and Research (CDER). As a pivotal hub for pioneering approaches to clinical trials, C3TI is poised to revolutionise drug development efficiency. At N-of-1 Hub, we're beyond excited about this groundbreaking initiative and are eager to highlight its potential impact on expediting the development of safe and effective new drugs to the medical community. 


For years, N-of-1 Hub has championed innovative clinical trial methodologies, aligning with our mission to transform healthcare through personalised interventions. With the establishment of C3TI, we see a unique opportunity to amplify our advocacy and foster even greater collaboration and advancement in the field.

Innovation is key to unlocking new therapeutic possibilities and addressing unmet medical needs.


We anticipate C3TI acting as a catalyst for transformative change, facilitating the exchange of best practices and insights across diverse clinical trial innovation initiatives. Through C3TI, we foresee a surge in the adoption of novel methodologies that streamline drug development processes and elevate patient outcomes.


We're particularly thrilled about the C3TI Demonstration Program, offering a dedicated platform for selected sponsors of innovative clinical trials to engage with CDER experts and showcase pioneering approaches. These real-world examples will be shared both internally and externally to inspire innovation across all therapeutic areas. This initiative perfectly aligns with our commitment to pushing the boundaries of traditional clinical research and forging new paths in personalised healthcare..


N-of-1 Hub is a consulting company that specialises in designing, conducting and analysing personalised clinical studies using single-case designs. N-of-1 Hub provides consulting and collaborative services to companies, clinicians, researchers, and healthcare consumers who wish to conduct personalised clinical studies using single-case designs. N-of-1 Hub also offers data management and analysis services and customised workshops and courses. Additionally, our training programs are tailored to equip researchers and clinicians with the skills needed to excel in personalised clinical studies.


For more information on how N-of-1 trials can revolutionise your clinical research and improve patient outcomes, we invite you to contact us for a free consultation. Don’t forget to follow us on LinkedIn for the latest updates and insights in the field of personalised clinical studies.

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Are you a clinical researcher, academic, healthcare provider or medical educator looking to enhance your research capabilities? Our free consultation call is designed to help you design, conduct, and analyse N-of-1 trials and single-case experimental designs (SCEDs) with ease.

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