News Archive

June 10, 2015 - The presenters, Eric Distad, Director of Project Management for the Medical Device & Diagnostics Division at Novella Clinical, and Ori Ben-Yehuda, MD, FACC, Executive Director at the Cardiovascular Research Foundation (CRF) Clinical Trials Center, will discuss how medical device developers can avoid the pitfalls and challenges of conducting cardiovascular clinical trials. The live broadcast takes place on Thursday, June 25, 2015 at 12pm EDT (5pm BST/ GMT +1).

Participants will:

• Understand critical trial design considerations, including comparator strategy, blinding, site and patient selection
• Learn how to create meaningful, measurable endpoints for effective evaluation
• Recognize how and when to utilize core lab services

As cardiac technology continues to advance, medical device developers are working rapidly to bring new implantable cardiovascular devices to market. When preparing for a clinical trial, there are multiple factors to consider in the scientific design and implementation of your study. Careful consideration of trial design, site/patient selection, data collection and endpoint evaluation are vital to success. In this webinar, we will share best practices to help guide cardiovascular device developers down the path to approval.

Principal investigators and sites:

Because of subspecialist overlap in cardiovascular device treatment, sponsors may find themselves in competition for particular physicians to participate as principal investigators. Sponsors cannot assume that certification and expertise in one type of device will translate to a different technology. When selecting a site, consider including locations with less extensive clinical research portfolios to increase the speed of patient recruitment.

Patient selection:

Many sponsors seek to enroll patients with long-standing heart conditions. However, this practice adds levels of complexity that threaten timelines as it impacts patient identification, informed consent and treatment decisions. It is important to model different trial populations to evaluate the potential efficacy and safety of the device.

Complexity in data collection:

Analyses and collection of data in cardiovascular trials requires a carefully defined process during protocol design. Sponsors and their partners need to agree on the markers, measures and methods that will precisely define the trial endpoints to assure those assessments are uniform across each trial site. Consider how other researchers are defining the measurements, along with the use of historic or predicate device data for baseline comparisons.

Lab partnership:

In addition to examining a device against a standard of care, some trial designs also may involve sham treatments or no interventions, as it is not common for device trials to be double- blinded. Therefore, the evaluation of study data by a single, blinded core laboratory or cardiac catheterization laboratory is essential.

To learn more about this one-hour complimentary webinar visit: Interventional Cardiovascular Device Development: Considerations in Clinical Trial Implementation