Strategic design is the process of translating game-changing decisions into clear, concise, and complete instructions for execution: the who, why, how, what, when, and where of operations. Encoding them into the designs of systems and services allows us to “take more risk while avoiding it.” Having it both ways requires dexterity in switching between the abstract and the concrete. It requires thinking and tooling that is at once simple and sophisticated, advanced and primitive. This talk gives two examples of strategic design in practice: within a government agency and a major healthcare initiative.

The clinical research landscape in the UK is rapidly evolving to become more patient-centric in how we identify, engage, and enroll participants. For example, we know that there is greater inclusivity from reaching out to a community population to participate in research, as compared to waiting for the right patient to come to the right research unit at the right hospital where a trial happens to be taking place. This presentation will describe a number of patient-centric initiatives that are being implemented which span primary and secondary care, and the community in the UK to boost recruitment and retention to later-phase commercial trials. It is an opportunity to hear some of the current thinking and new ideas about how the next generation of clinical trials will be delivered, and what the impact of these changes will be. The multi-stakeholder panel will discuss how these initiatives will benefit the patient, industry, and other key stakeholders.

• Understand new patient-centric initiatives spanning primary, secondary, and community care in the UK that boost recruitment
• Delivering the first virtual trials in the UK: Understand what is involved and the implications of the virtual trial
• Discover the benefits of a multiple modality approach to patient recruitment
• Identify where the PIC model will derive the most benefit for your trial
• Learn about best practices: Challenges, successes, and solutions in patient engagement in clinical research design

For over a decade there had been a focus on transforming the clinical trial paradigm through technological innovation to make it more efficient and a better experience for patients, but changes have been slow in this naturally conservative environment. Part of the challenge is the fragmented landscape of initiatives and a lack of standards for future clinical trial archetypes. How can a 'moonshot' concept help accelerate change in clinical trials?

I will talk about my journey from Division I football and top NFL prospect to cancer patient. My experience of undergoing chemo and radiation and fighting through a battle with brain cancer has enabled me to leverage my story to make a difference in the lives of those affected by rare diseases. The attendees will gain insights into what it means to be a volunteer at the front lines of oncology research and clinical trials. New approaches to partnering with advocates, disease communities and young researchers will be shared. In addition, we will discuss the future of rare disease research and the impact that this research is having in the world of COVID-19.

Discuss the impacts of COVID-19 on clinical trials, including delays in patient enrollment and study initiation, inability of patients or sites to comply with scheduled visits, impacts of limited staffing and study materials due to reprioritization, and more. Discuss how best to address statistical implications from missed patient visits, tests, and increased protocol deviations; strategies to advance decentralized trials and remote monitoring; and near-term and longer-term strategies to mitigate the impacts of COVID-19 on clinical trials.

Patients are the center of all our actions and our daily work. Digital solutions are providing unique channels and opportunities when it comes to our patients' interactions. We are experiencing new dimensions in this world of direct-to-patient trials, remote trials, virtual trials, and seamless digital interactions. A special set of technical capabilities and a relationship with patients based on trust is required to lead us through a fully digitalized experience through the whole treatment journey. What is the role of patients in the new treatment regimens and how has this changed in the digital era? What are the key challenges? Digital solutions vary from simple patient support programs to digital therapeutics and complete virtual interactions. In the session, we will be covering the new patient journey now and in the future with new understanding of the patient's role in the management of digital assets and digital panning.

There is a growing interest in the collection of patient data beyond the traditional realm of randomised clinical trials (RCTs), for which costs have steadily ballooned in recent years, prompting pharma to turn to routinely collected data as a means of creating more efficiency in their research. Pragmatic clinical trials (PCTs) are research investigations embedded in health care settings designed to increase the efficiency of research and its relevance to clinical practice. Costs can be reduced by building RCTs upon existing registries and electronic health records (EHR), an approach that is increasingly supported by health authorities. This presentation will discuss and present recent efforts and regulatory aspects of conducting the next phase of PCTs for label inclusion.

Medicine as systems science characterizes the health state by measurable properties. A power of digital medicine is the capacity to design better tools for assessing disease features that correlate medical systems and clinical outcome. We will review a specific case showing how this paradigm can transform our clinical trial landscape.

Drug development programs in companies are predicated on biological insights supporting a hypothesis of target and its role in disease etiology. This presentation will focus on the data modules essential for linking discovery biology to early/late stage clinical development and the leveraging of AI in the integration of the various dataflow to make data-driven informed decisions and ensure success. It will outline how to utilize data, AI analytics with RWD-based support for planning drug development to propel products all the way through the clinic.

The pandemic drove a violent shift to a fully virtual online world, radically changing how we shop, educate, hold business meetings, and obtain care. There will be a new hybrid normal that lands between the “old world” and fully online. These personal experiences in 2020 provide a roadmap for the future of clinical trials, and it will involve approaches we have not yet realized.