Once Upon a Time...is a great beginning for a story, but not for a clinical trial protocol. With high complexity, numerous procedures, and other factors, study sites and participants complain about the burden of clinical trials. Can there be a happy ending? Merck’s approach to protocol development aims to find that balance.

The need to evolve clinical trials to include broad adoption of technologies and solutions, as appropriate, is highly important to enable greater flexibility, patient choice, and diversity in clinical trial populations. Join us to learn more about important and helpful tools developed to modernize clinical trials and explore the value demonstrated by their use to date. We will also share insights and barriers experienced from the perspective of clinical research professionals while implementing decentralized clinical trial elements as part of global trials.

The unprecedented increase in the volume of data from digital technologies is an opportunity to address long-standing challenges in clinical research. To ensure equitable outcomes from clinical trial innovation requires an initial acknowledgment and sustainable plan. During this session, we will highlight recent activities to showcase the impact on patients, providers, and other key stakeholders.

The audience will gain insight in the independent pharmacies' community outreach and the impact they make in a community. The pharmaceutical industry will gain key points on how to leverage independent pharmacies in clinical trials to improve recruitment, retention and diversity in clinical trials.

Recommendations, guidance, and tools exist to implement decentralized clinical trial approaches. But how is the clinical trial enterprise doing with DCT implementation? This presentation will provide a state of the state of decentralized clinical trials, discuss the gaps that remain to advance the uptake of DCT approaches, and identify areas of progress or potential solutions to address those gaps.

DTRA’s member organizations, including pharma sponsors, site networks, technology, and service providers, have collaborated on 12 initiatives to address challenges related to designing and implementing decentralized trials. Additionally, DTRA partners with cross-industry consortia, such as ACRO, ACRP, and CTTI. SCRS and Transcelerate to align on key areas of focus and need. Panelists will share a playbook that includes tools, processes, and frameworks from this cross-collaboration to support the strategic, fit-for-purpose DCT adoption.

This presentation will provide: recommended strategies to focus on patients as the center of care; essential element of a solutions “village” for providing value to trial design, innovation, and connected services; and considerations of planning and developing an ecosystem of best-in-class partners.

Sponsors, sites, and patients have unique motivations and challenges in the conduct of clinical trials. Aligning the interests of stakeholders requires a thorough understanding of the goals and respective journey that each takes.Community-based clinical trials are an emerging option to level the playing field, position patients at the center of the end-to-end experience, and address long-standing inequities that result in gaps in scientific evidence applied to care.

The audience will gain a deeper understanding of the operationalization of a completely decentralized trial. Audience members will leave with the knowledge of our key lessons learned including protocol designing to align with a DCT, screening and enrollment process management, remote clinical and ePRO assessment, direct-to-patient drug supplying, and proactive risk identification and mitigation.

We’ve witnessed an explosion of technology solutions offerings for clinical trials. There is mounting evidence, however, that the fragmented nature of these solutions is causing significant disruption and preventing meaningful efficiency improvements in trials. The community needs to embrace a new concept of a unified clinical data platform to address the growing multi-source data complexity challenge of modern clinical trials to finally solve these persistent issues.

DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, and direct delivery of study drugs and materials to patients’ homes. This talk will discuss the post-COVID strategies for connected devices implementation in hybrid trials.

This talk will focus on the use of digital health technologies(DHTs) to advance medical product development—from assessment to interventions in real-world settings. I will share learnings from clinical research studies to help inform the development of robust digital endpoints and interventions focusing on improving behavioral outcomes.

This presentation will share the NIH Framework for digital technologies' validation in clinical trials.