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.

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.

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.

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.

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.