Upcoming Webinar Featuring FDA Panelists – October 16 at 2:30 pm EDT
COVID-19 AND CLINICAL TRIALS
Remote Safety Monitoring for Clinical Trials – Pandemic and Beyond
The COVID-19 pandemic has accelerated the movement of healthcare from the hospital and outpatient facilities to the home, significantly impacting clinical trials. It is likely that the movement toward remote cardiac monitoring and remote clinical trial visits will continue well into the future. As such, it’s essential that clinical trial investigators can confidently monitor patient safety and sponsors have confidence that regulators will accept data that is gathered in a remote format.
This webinar will explore some best practices for remote cardiac monitoring with perspectives from industry experts and three FDA representatives.
This Cardiac Safety Research Consortium webinar will be moderated by CSRC Executive Director, Jonathan Seltzer, MD, FACC and is sponsored by BioTel Research. The agenda features regulatory and industry experts:
- Use of Remote Captured Data to Assess Cardiac Safety – Fred Senatore, MD, PhD, FACC, Medical Officer/Clinical Team Leader, Division of Cardiology & Nephrology, CDER, FDA
- Cardiac Monitoring Medical Device Landscape— LT Stephen Browning, BS, Assistant Division Director – Blood Pressure and Flow Devices, Division of Cardiac Electrophysiology, Diagnostics and Monitoring, CDRH, FDA
- Practical Aspects of Remote Cardiac Safety Monitoring—Polina Voloshko, MD Chief Medical Officer, BioTel Research
- Case Study: Remote Physiologic Parameters during the COVID-19 Pandemic—Ken Stein, MD, Senior Vice President, Chief Medical Officer for Rhythm Management and Global Health Policy, Boston Scientific
- Regulatory Landscape for Clinical Outcome Assessment— Elektra Papadopoulos, MD, MPH, Acting Director, Division of Clinical Outcome Assessment, Office of New Drugs, CDER, FDA
- Considerations for Remote Capture of Clinical Outcome Assessments – Ken Faulkner, PhD, Vice President, eCOA Scientific Services, eRT
This webinar is free to join, but you must register in advance to participate. Please contact firstname.lastname@example.org with any questions.
CSRC’s previous webinar: Implications of the COVID Pandemic on Cardiovascular Issues in Clinical Trials: Focus on Biomarkers may be accessed here.
Annual Meeting Postponed
The CSRC Annual Meeting originally scheduled for June 8, 2020 has been postponed. We are currently developing plans for a virtual meeting and will contact the CSRC community as soon as plans have been finalized.
New Publications Available
Two new CSRC papers were recently published in American Heart Journal. Click the links below to access the materials.
- Assessing cardiac safety in oncology drug development
- Restricted mean survival time for the analysis of cardiovascular outcome trials assessing non-inferiority: Case studies from antihyperglycemic drug development
New CSRC Executive Director Named
Congratulations to Jonathan Seltzer, MD, MBA, MA for being named CSRC's Executive Director! Dr. Seltzer serves on CSRC's Executive Committee and Scientific Programs Committee.
The Cardiac Safety Research Consortium is dedicated to advancing scientific knowledge on cardiac safety for new and existing medical products by building a collaborative environment based upon the principles of the FDA’s Critical Path Initiative as well as other public health priorities.
Initiatives and Projects
For more than a decade, we have made great strides in advancing knowledge of cardiac safety in clinical research through conferences, publications, and research projects. We are currently planning for the following think tanks in 2018:
New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrythmia Assay (CiPA) (Spring)
Understanding Cardiogenic Shock and Defining the Concept of “Pre-shock” (Fall)
- Concept of "pre-shock" and develop consensus statements for clinical/research use
- Mechanical circulatory support in treating "pre-shock"
Novel Approaches for the Evaluation of Mobile Technologies in CV Medicine — Scientific rigor, Innovative Methods, Regulatory Acceptance (Fall)
- Integrating devices into supporting cardiovascular safety and efficacy endpoints
- Promised efficiencies of mobile technology in clinical trials
- Device features, patient features, endpoint validation, and regulatory considerations
- Arrhythmia Normal Limits Combined Holter/12 Lead ECG Analysis
- CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study
Submit Your Ideas
SUBMIT YOUR IDEAS FOR THINK TANKS AND PUBLICATIONS
In order to promote the spirit of collaboration the CSRC highly values, we ask that you submit your ideas for future research projects, think tanks, and white papers. By hearing directly from our members, we can ensure that the topics researched, discussed and published are important to you.
CSRC members benefit from engaging in pre-competitive collaboration with cardiac safety professionals on vital research topics and projects. Working together, we have the opportunity to accomplish public health objectives that no single stakeholder could achieve on its own. The CSRC takes to heart the African proverb shared at one of our pediatric safety think tanks:
“If you want to go fast, go alone. If you want to go far, go together.”
In that spirit, we celebrate our second decade of excellence in
cardiac safety research, and going there together.