This comprehensive review will delve into key aspects of using DCTs and RWD/RWE, incorporating case studies and addressing FDA compliance and inspection readiness. Topics covered include remote clinical site inspections, RBM applications, and the integration of Digital Health solutions.

This large RWE study involved both a unique, population-based design and a rapid, cost-effective approach conducted to support a new FDA indication for the Onclarity HPV assay, using PreservCyt liquid-based cytology, during cervical cancer screening. We used retrospective evaluation of real-world cervical screening, diagnosis, and treatment data from the New Mexico HPV Pap Registry (NMHPVPR) and used associated, de-identified cervical specimens collected in PreservCyt. The study was conducted to determine the safety and efficacy of Onclarity for use with PreservCyt LBC.

The question that still remains is how much clinical evidence is sufficient to acquire EU MDR approval? The answer is dependent on many factors. In this presentation we will discuss the factors and the approaches as well as overcoming the challenges in obtaining EU MDR approval.

With EU MDR, the burden of clinical evaluations has increased substantially. In this presentation, we will share our experience and lessons learned in writing EU MDR complaint clinical evaluation reports (CERs) for different types of medical devices. How can we perform clinical evaluations in efficient ways that are sustainable? Can we leverage clinical evaluations to go beyond compliance needs?

The EU MDR 2017/745 was published since approx. 6.5 years and as of today it remains unclear which level of evidence is sufficient to address notified body expectations for legacy devices, well-established devices, and new innovative technologies of the various risk classes. During this presentation, the knowledge gained since the implementation of the EU MDR will be shared and recommendations will be given to innovators and manufacturers to establish a good clinical evidence strategy for the EU.

Project teams can maximize investments and minimize costs by efficiently identifying sites that can activate and enroll quickly, and provide clean and complete data, towards a smooth competent authority approval.  Such scenarios typically don't exist without a few hazards on the road; however, project teams can drive closer towards that reality with the right data and systems in tow. Abbott's CTMS and BI dashboards can fill the gaps between theoretical and reality by providing project teams key activation, enrollment and data quality metrics, and intuitive clinical data systems, to chart a route to the final destination.

Bringing a new medical device to market benefits from efficiencies not just at the site level, but in the interface among the sponsor/CRO, the site, and the clinicians who will eventually be adopting the new technology into their regular practice.

Embracing diversity in clinical trials is an essential step towards equitable healthcare. By including a wide range of participants from diverse backgrounds, clinical trials can yield insights that better represent the real-world patient population. This inclusivity ensures that medical treatments are safe and efficacious for everyone. Using the FDA’s Diversity Plan as the backdrop, we will discuss actionable strategies that can be designed to enhance inclusivity in IVD clinical trials.

Risk Management is often confused with risk analysis and treated as a one-time event rather than as an ongoing process. Risk management is intended to be integrated across quality, regulatory, and clinical activities, with continual feedback loops. Results of risk management activities within each of these areas establish the requirements and objectives of the other two, creating a web of interrelationships that is critical to effectively managing risk. Risk management methods, while based on common concepts, also differ in their execution/application within each area. This session will first clarify the integration requirements and then establish clinical trial risk management requirements.

A positive outcome of the COVID pandemic and public health emergency was more rapid adoption of digital health technologies in both research and healthcare settings. The broad scope of these digital technologies includes categories like mobile health (mHealth), health information technology (Health IT), wearable devices and telemedicine. Learn about FDA’s plans for Artificial Intelligence (AI), Machine Learning (ML), cybersecurity and more during this update and overview of FDA’s new DHCoE.

The growth of digital health technologies in the past decade has driven change to the regulatory landscape around the world. This evolution has made an impact on patient access to these technologies which has also highlighted the increasing need for health equity. Although there are challenges within the new regulatory landscape, bringing new technologies to the market ultimately benefits the patient.

What does “clinical strategy” mean? Strategy is defined as a general plan to achieve one or more long-term or overall goals under conditions of uncertainty. “Clinical strategy” can be defined as a general plan to generate sound evidence that a medical device is (clinically) safe and effective & performs as claimed during its lifecycle; for the purpose of product registration/approval/clearance in defined target markets; for marketing reasons to substantiate defined claims supporting economic success of the product; by economically viable means; and in a predictable manner.​

This session will provide attendees with an overview of the MDR requirements related to clinical investigations conducted in the EU, and more importantly, will provide the attendees with insight and knowledge of what a notified body needs to consider as part of its conformity assessment to gain CE marking. The session will place emphasis on articles 62-82 of the MDR alongside Annex XV requirements and will also provide considerations for when clinical investigations are conducted outside of the EU with the intent of gaining EU conformity in reference to ISO14155:2020.

Abbott’s custom CRF Builder Application is projected to reduce work effort of Clinical Data Managers (CDMs) and Study Database Managers (SDBMs) by 75% for CRF revisions and 50% for study database builds, saving up to 4,000 hours of work in 2024. The CRF Builder Application allows study teams to maintain gold standard CRF Design across studies and within specific therapies to collect quality and consistent data while eliminating the burden of graphic design. The CRF Builder can be utilized to build and maintain a library of generic and standardized CRFs and in the future, a library of standardized annotations and database specifications, to eliminate the variability between study builds and reduce the number of hours needed to launch a new study or to execute revisions within an existing one. The application will also serve as a CRF Casebook management system, allowing revision history to be tracked and maintained with ease. The CRF Builder Application marries the process of CRF design with database build, reducing work effort while maintaining standards across all studies.

CLEHR (Clinical from EHR) was developed to achieve Abiomed’s vision to expand access to information from EHRs beyond the limitations of EDC and to reduce manual copy and paste entry of information into EDC systems. The team will present the challenges encountered and solution approaches to establish eSourcing of EHR data across Abiomed research sites. The team will share how the many-to-many model of CLEHR can scale the network across studies, sponsors, and sites.

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.