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      2. Championing Patient-Centric, Data-Driven Clinical Trials

      Championing Patient-Centric, Data-Driven Clinical Trials

      Championing Patient-Centric,
      Data-Driven Clinical Trials

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      The Question that Drives Clinical Trial Innovation

      One common question I receive as Janssen Clinical Innovation’s Global Team Lead is, “what will clinical trials look like in five years, 10 years or beyond?” I believe that there is unlimited potential for clinical trial innovation. Through technological advancement and application, as well as human ingenuity, the opportunities for improvement are vast. A more interesting question may be, “what will stay the same?” To which I have a concise answer – our commitment to our patients.

      At Janssen, we champion a patient-centric approach to clinical trials because it’s patients who help us think holistically about the health journey. They are also at the heart of our mission of addressing unmet medical need to create a future where disease is a thing of the past.

      Delivering on Our Mission and Vision through Steadfast Collaboration

      Through our global reach comes a responsibility and unique ability to leverage vast scientific expertise and wide-ranging collaboration networks – across industry collaborators, health authorities and governmental institutions – to protect public health and accelerate care for patients. Our ability to leverage a cohesive network of insights and experience allows for more nimble, informed, and responsible decision-making when responding to the ever-evolving needs of the healthcare community and the patients we serve together.

      I recently participated in the 10th annual DPharm: Disruptive Innovations in Clinical Trials virtual conference and had the opportunity to connect with various stakeholder groups from around the globe. We shared case studies, key learnings and aspirations on how to fundamentally change the way clinical trials are designed and experienced.

      During the event, I had the privilege of moderating the keynote session with Amy Abernethy, M.D., Ph.D., Principle Deputy Commissioner of the United States Food and Drug Administration (U.S. FDA), to talk about tangible steps for advancing industry-agency collaboration to modernize clinical trials, examining FDA culture in the post-COVID era, decentralized trials, collection of real world data and more.

      Reflecting on our conversation, I found the discussion around barriers and opportunities for implementing direct-to-patient approaches, such as home health visits, local patient service centers and telehealth, very inspiring and motivating, as these are a few of the many innovations we are championing at Janssen.

      Applying a Human Lens to Transformative Technologies

      New and emerging technologies are greatly impacting the ever-evolving landscape of clinical trials, but nowhere is that more prevalent than in the space of patient-centricity. At the DPharm conference, five of my Janssen colleagues showcased various programs we are pioneering to drive a paradigm shift in the way Janssen delivers value to investigators, site teams, patients and participants, not only at the end stage of the clinical trial, but throughout the entire process.

      • Monique Adams, Ph.D., Director, Janssen Clinical Innovation, led a session on adapting the decentralized clinical trial model for the unique needs of patients with cancer. She also hosted a fireside chat with Marty Yudkovitz, a veteran senior media and technology executive, most recently of the Walt Disney Company, on how Disney maintains service excellence in the end-user experience at their parks, and how to infuse these strategies into building a better patient experience.
      • Bert Hartog, Ph.D., Senior Director, Janssen Clinical Innovation, moderated a multi-stakeholder panel on the use of conversational AI in clinical studies, examining how voice technology provides critical patient input and may improve patient experiences in clinical research and trials.
      • Martine Lewi, MBA, Ph.D., Scientific Director, Janssen Clinical Innovation, conducted a presentation on how eSource and EHR2EDC solutions are enabling the convergence between care and research, creating connected, augmented real-world data, and the potential benefits for patients, investigators, regulators and industry.
      • Miruna Sasu, MBA, Ph.D., Head of Janssen Feasibility Centre of Excellence and Advanced Analytics, and Monica Teall, Associate Director, Janssen Feasibility Solutions, discussed their collaboration in building a data-driven platform designed to enable data sources in one place, identify burden scores for sites and patients, streamline processes and improve patient experiences.

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      Why I Champion Better Trials. Made Together.

      At Janssen, we are working to shape the future of clinical trials by improving and innovating on every aspect of the process, from integrating the transformational power of our data science capabilities to embracing disruptive technologies to drive inclusion and equity for diverse patient populations and geographic regions. Our philosophy is Better Trials. Made Together., which consists of stakeholders, patients and our clinical research sites working together in an effort to create better, faster and more inclusive clinical trials.

      I believe it is imperative to have patients involved throughout the entire study to ensure their insights, experiences and inputs are considered at the design phase and throughout the clinical trial process. It’s an important operational model that has the potential to improve enrollment, engagement, retention, and diversity within trials for the benefit of all patients, and ultimately, people.

      We live in an increasingly connected world – where life and technology evolve in exhilarating, inspiring and sometimes unexpected ways. I’m excited for all the new things ahead, knowing that no matter how greatly the day-to-day changes, our dedication to patients will always remain the same.

      To learn more about Janssen, our team and the latest technologies and innovations we are championing, visit the Janssen Clinical Innovation section of this website.

      October 19, 2020

      Tammy Guld, M.S.
      Tammy Guld, M.S.
      Tammy Guld, M.S.
      Tammy is the Global Lead of Janssen Clinical Innovation, with more than 20 years of diverse industry experience. She leads the creation and scaling of new operational approaches and technologies into clinical research with the goals of expediting drug development, reducing overall costs, and improving patient and site experiences.