Steven Sulkin, CEO, SimuLyve International

Marina Ziehn, PhD, Global Med. Affairs Dir. Neuroscience, Novartis

Markus Krüer, PhD, Head Clinical Project Mgt, Merz

Nico Wegener, PhD, Senior Clinical Project Mgr, Merz

Dave Matthews, Clinical Project Dir., Merz

Training worldwide staff on complicated protocols virtually with the added issue of language barriers can seem daunting. Our panel of virtual experts will show you how to perfect virtual skills and enhance virtual meetings.

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

Different endpoints derived from wearables can require very different wearable sensors.  Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain.  Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.

Transforming conventional clinical trials through Decentralized Clinical Trials (DCTs) by placing some trial elements, typically conducted at clinical research sites, remotely. DCTs can be executed through procedures that vary from conventional trial models such as telemedicine and mobile healthcare providers (HCPs), with the aim of making trials more accessible by integrating them into the daily lives of trial participants.

How do we take a page out of real-world innovations to improve patient engagement in clinical trials? This presentation focuses on the day-to-day use of technology and patients’ surrounding communities in everyday scenarios. We will explore how these concepts are like the challenges and barriers our patients experience in clinical trials and how we can bring these proven and innovative real-world solutions to patients and truly disrupt how we support them.

As our healthcare system continues to strive for best possible outcomes, we need to recognize that what we’ve always done isn’t working; as an ecosystem, we’ve been adding new tools based on how we want patients to act, yet what we really need is to design our solutions around how people actually behave. Telehealth, digital health tools, and patient portals are expanding initiatives, but we know that technology alone doesn’t drive behavior change as we see patients, providers, consumers, and other stakeholders struggle to begin to engage with the offerings, let alone to continue engaging with them in the long term.

During this presentation, we will share insights regarding differences in informed consent document read times, video watch times and knowledge check scores among different populations, such as diagnosis group, age, and race. There will also be discussion regarding the relationship between engagement during the eConsent process and clinical trial completion as well as insights into the quality and compliance benefits of eConsent. Recommendations will be presented to enhance the eConsent process, such as ways to ensure the eConsent is engaging based on the population being worked with.

Patients are becoming “point of care” in clinical development and healthcare, empowered by integrated and continuous support. If a patient’s status and experience can be tracked continuously for self-monitoring and communication with physicians and other stakeholders, patients could be better informed and motivated. Some severe consequences may be avoided by discerning in advance of significant change in patterns. This presentation will explore innovative approaches (digital bot, wearable, etc.) to assist patients in continuous tracking and integrated support in a cohort of patients living with a chronic condition.

Real-world data (RWD) are those data collected outside conventional randomized clinical trials to evaluate what is happening in the real world environment. While the focus of evidence generation using RWD has traditionally been on clinical endpoints (i.e. safety and effectiveness outcomes), in order to provide a more holistic view of the experience of disease and well-being there is a need for RWD that captures the patient lived experience. Novel sources of data from clinical practice, social media, patient reported outcomes, and wearable devices are part of the RWD ecosystem and contextualizing real-world data within the pharmaceutical industry will be critical to ensure the data is fit for regulatory decision making. It is critical to incorporate and contextualize the patient perspective into real-world evidence strategies for regulatory decision making. This session strategizes how to better contextualize (i.e. linkage across data types, social, behavioral, and spatial contexts of RWD) the patient perspective within RWD utilizing concepts and methodologies from the social/behavioral sciences.

Addressing the need for an easier and more comprehensive online search tool for accessing clinical trials. Includes a discussion around what sites, sponsors, and CROs can do to optimize the enrollment process and minimize disparities in clinical research to expedite treatment development. Additional discussion on how patient advocacy groups are providing CenterWatch iConnect to their members to educate them on the value of clinical trials to support the search for cures.

Decentralizing clinical trials changes the factors driving patient burden by increasing the patient’s level of responsibility for accurate data collection. We'll discuss the necessity of finding solutions that contribute to high quality data capture, compliance, and support to enable a better patient experience and achieve study success.

The Janssen Global Development Feasibility team has built a sustainable global model to support every trial with data science and technology at an industrial scale. This presentation will focus on briefly showcasing several tools and algorithms that were built internally to bring unfathomable value and data-driven solutions to trial teams that aids them in making solid decisions on how to operationalize each trial for ultimate success and decreased patient and site burden.

We often hear of huge numbers of patients that can be identified by their data, but what is the reality in terms of their trial participation? The funnel can be steep to the point of not viable. This presentation will review different approaches to realizing the value from data as a source of patient identification, engagement and explore linking data to key interception points in the patient treatment pathway.