CSRC Spearheads Creation of First National Pediatric Cardiac Screening Database

FDA, industry, and patient advocacy groups join effort to advance effective cardiac screening

Durham, NC, October 15, 2020 – The Cardiac Safety Research Consortium (CSRC) announces the establishment of a first-in-kind national database of pediatric cardiac screening information aimed at advancing the ability to discover potentially dangerous pediatric cardiac conditions and preventing sudden cardiac arrest or death in young people (SCDY). This database is being developed through a multidisciplinary partnership formed by the CSRC with support from the U.S. Food and Drug Administration (FDA) with the goal of identifying and overcoming barriers to effective pediatric cardiac screening.

“For the first time, we will have access to high-quality pediatric data on a scale that will allow us to further research a wide array of cardiac issues facing children – from sudden cardiac arrest to cardiac side effects of drugs to the cardiac effects of having had a COVID-19 infection,” explained the project’s principal investigator, Salim F. Idriss, MD, PhD, executive co-director of the Duke Pediatric and Adult Congenital Heart Center and director of pediatric electrophysiology at Duke University Medical Center. “Establishing a scalable, reliable national warehouse of pediatric cardiac screening data, including metrics such as data completeness, ECG interpretability, and assessment of long and short-term follow up, is the key to improved cardiac care in this population.”

“CSRC’s mission is to drive collaboration among public health, academia, government and industry experts to address complex cardiac safety issues,” said Jonathan Seltzer, MD, MBA, FACC, executive director of the CSRC. “This database is a prime example of how collaboration can fast-forward research for a pressing public health problem.”

Ten community screening organizations from across the country have been recruited to date as partners to help establish the national data warehouse. The organizations were recruited through national project partner, Parent Heart Watch, whose prevention-driven initiatives include cultivating local champions who create community programs focused on the prevention of SCDY. Parent Heart Watch anticipates actionable outcomes from this collaboration, in particular, converting research into strategies that affect systemic change in pediatric primary care protocol. “At the heart of our movement is the knowledge that sudden cardiac death can be prevented,” explained Martha Lopez-Anderson, executive director. “This project fully aligns with our mission to ultimately empower medical practitioners and families to recognize warning signs and risk factors before tragedy strikes—it’s truly a life-saving initiative.”

In addition to Parent Heart Watch, current partners include:

  • Community screening organizations including: Championship Hearts Foundation (Texas), Cody Stephens Go Big or Go Home Memorial Foundation (Texas), Saving Hearts Foundation (California), Eric Paredes Save A Life Foundation (California), Screening America (South Dakota), Heart Screen New York (New York), Peyton Walker Foundation (Pennsylvania), Hearts for Athletes (Alabama), Thomas Smith Memorial Foundation (Michigan), Play for Jake Foundation (Indiana)
  • Academic leaders from Children’s Hospital of Philadelphia, Lurie Children’s Hospital, Cleveland Clinic Lerner College of Medicine, and Baylor College of Medicine
  • Industry partners including: AMPS LLC (Analyzing Medical Parameters for Solutions), AstraZeneca, Cardiac Insight Inc., Eli Lily, ERT, and IQVIA

The study is ongoing, and anyone interested in supporting the initiative is encouraged to contact CSRC about how to get involved. “Partnership is essential to this effort, and we welcome others who are interested in lending their support – financial or otherwise – to the study,” Dr. Idriss added.

About Cardiac Safety Research Consortium

The Cardiac Safety Research Consortium (CSRC) provides leadership and guidance for regulators, public and private clinical researchers, and industry through an open, interactive forum to collectively address cardiovascular related issues in clinical trials for both new and existing products. The organization offers unique resources and a collaborative structure that allows for valuable contributions to scientific study design, data analysis and interpretation, and dissemination to the public. CSRC’s non-competitive environment allows for experts to engage in a rigorous, transparent process to define an optimal path forward in the advancement of cardiac safety research, knowledge, and excellence. The impact of CSRC and the thought leadership of its members on key cardiac safety research issues has a proven track record of benefiting the global scientific and regulatory community. For more information about CSRC, visit their website or email info@cardiac-safety.org.

Scientific Programs Committee Chair Attends CEC Summit

CSRC Executive Committee member and Scientific Programs Committee Chair Jonathan Seltzer, MD, MBA, MA, attended the inaugural 2018 CEC Summit on September 26-27, 2018. This event, cohosted by the Duke Clinical Research Institute and Stanford Center for Clinical Research, brought together thought leaders from academia, industry, and government to establish consistent standards globally for clinical events classification (CEC) and adjudication in clinical trials.

“This meeting was special as it examined both the scientific justification for endpoint adjudication as well as operational best practices. It is likely that future meetings with this group will deliver innovative solutions to issues whereby adjudication strategies can be more broadly applied, but in an intelligent, cost-effective manner,” said Seltzer, who also serves as the president and CEO of ACI Clinical.

Event panelists and speakers represented various organizations including the U.S. Food and Drug Administration (FDA), Harvard University, Cleveland Clinic, George Clinical, the Cardiovascular Research Foundation, Cardialysis, and more.

Hear what others had to say about the event in this recap.

Over the Edge for Cardiac Safety

October 4, 2018

Salim Idriss, MD, PhD, principal investigator for CSRC’s Sudden Cardiac Death in the Young initiative, is going Over the Edge for cardiac safety. What does this mean? Dr. Idriss is participating in the 2018 Over the Edge fundraiser on behalf of sudden cardiac death in the young initiatives. On Saturday, October 13, Dr. Idriss and Clare Matti, assistant director of Regulatory Services at the Duke Clinical Research Institute, will rappel 17 stories down the side of the historic 21c Museum Hotel in downtown Durham.

This event, sponsored by Duke Children’s Hospital, helps support patient care, medical research, and physician training at Duke Children’s.

Through your 100% tax-deductible donation, you can help support efforts to end sudden cardiac death in the young. Hear what Dr. Idriss has to say about the event.

DONATE HERE.

CSRC forms partnership with ACCP

August 1, 2018

In July 2018, the American College of Clinical Pharmacology (ACCP) and Cardiac Safety Research Consortim announced the signing of a collaborative Memorandum of Understanding (MOA). CSRC and ACCP will work together to develop, plan and conduct various educational events and programs. The partnership will also develop and produce research and policy statements/position papers relevant to the fields of clinical pharmacology and the cardiac and vascular safety of medical products.

Two collaborative activities defined in the agreement are already underway. First, a group of coauthors from both organizations is preparing a joint position paper on the use of the heart rate-corrected J-Tpeak interval as seen on the human electrocardiogram for purposes of evaluating a new drug’s potential to induce Torsade de Pointes, a rare polymorphic ventricular arrhythmia that typically occurs in self-limiting bursts and can lead to symptoms of dizziness, palpitations, syncope, and seizures. Torsade de Pointes can occasionally progress to ventricular fibrillation and sudden cardiac death.

Second, a CSRC/ACCP sponsored symposium will be held September 25th at the 2018 ACCP Annual Meeting in Bethesda, MD. At the symposium, titled “The Challenging World of Cardiac Evaluation & Utilization of Concentration-QT Analyses of Phase I Data to Waive the Thorough QT/QTc Study Requirement,” Chairs and Faculty Speakers will present industry, academia and regulatory agency viewpoints. ACCP will provide CME & CPE credits for the course.

CSRC and ACCP look forward to the continued opportunities that will arise from this new collaboration. If you are interested in becoming involved in these activities, please contact us at info@cardiac-safety.org.

CSRC Committee Chair to Moderate at CEC Summit

July 18, 2018

On September 26-27, 2018 the Duke Clinical Research Institute and the Stanford Center for Clinical Research will cohost a CEC Summit, an exciting new educational event at the Chicago Hilton O’Hare. Thought leaders from academia, industry, and government will be in attendance including CSRC Executive Committee member and Scientific Programs Committee Chair Jonathan Seltzer, MD, MBA, MA, who will serve as a moderator.

Join Dr. Seltzer and other experts from around the country for provocative and challenging discussions on various topics including CEC audit readiness, emerging trends in safety and efficacy, new technologies, and data quality and standards.

Visit the event website for more information.

CiPA Update

June 18, 2018

Dear CiPA Community,

On behalf of the CiPA Steering Team, I would like to share some exciting updates.

We are pleased to share materials from the recent May CiPA Update meeting, “The Future of the Assessment of Drug-Induced Arrhythmias and CiPA.” Presentations and a meeting synopsis are now available on the CiPA and CSRC websites: http://cipaproject.org/meetings-webinars/ and https://cardiac-safety.org/. Feel free to share these links with your colleagues!

In addition to the meeting materials, the recommended cardiac ion channel protocols are now available on the CiPA website: http://cipaproject.org/data-resources/. Protocols included are for hERG, CaV1.2 and NaV1.5. As more data is generated, the protocols may evolve and updates will be posted to the website. Should you have any questions, feel free to contact me.

Finally, the Myocyte Pilot Study MEA results were recently published in Toxicological Sciences and are available online ahead of print: http://cipaproject.org/publications/.

Look forward to regular, quarterly communications or check the CiPA website for more updates soon!

Jennifer Pierson, MPH
Senior Scientific Program Manager
Health and Environmental Sciences Institute (HESI) jpierson@hesiglobal.org

Announcement of Interest in the Domain of Drug Cardiovascular Safety

On May 31, 2018 the US Food and Drug Administration (FDA) released a draft Guidance for Industry entitled “Assessment of Pressor Effects of Drugs.” The purpose of the guidance is to advise sponsors with regard to their premarketing assessment of a drug’s off-target effect on blood pressure. Given that elevated blood pressure is known to increase the risk of stroke, heart attack, and death, a drug’s effect on blood pressure can be an important consideration in benefit-risk assessment. The guidance therefore recommends systematic characterization of a drug candidate’s effect on blood pressure during drug development.

This draft guidance is of particular interest to many members of CSRC since we held a think tank on this topic in 2012 and published a meeting report in the American Heart Journal the following year (Am Heart J. 2013;165:477-488). For 60 days after the draft guidance’s release, comments and suggestions regarding the document can be submitted to the FDA. All interested parties are encouraged to read the document and consider submitting comments and suggestions. The draft guidance is available here.

We are currently in the planning stages for a follow-up think tank that will be held after the 60-day open comment period has finished. More details will follow in due course.

 


 

CSRC, HESI, and FDA to Host CiPA Meeting

The CSRC, Health and Environmental Sciences Institute (HESI), and the FDA will host a two-day meeting titled, “New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrythmia Assay (CiPA),” on May 21-22, 2018 in Washington, D.C.

Discussion topics will include:

  • New approaches to evaluating the propensity of drugs to cause arrhythmias
  • Potential revisions to ICH E14 and ICH S7B Regulatory Guidances
  • Evolving data, ramifications, and potential regulatory implications from the Comprehensive In Vitro Proarrhyhmia Assay (CiPA)
  • The use of statistical methodologies in lieu of a positive control for QT studies
  • Updates from the FDA QT Interdisciplinary Review Team

View the draft agenda and register today!

CSRC Committees Gain New Members

Join us in welcoming Boaz Mendzelevski, MD; Anupam Agarwal, MD, MPH; and Mary Beth Sabol, MD, BSN to CSRC committees. Drs. Mendzelevski and Agarwal joined the Scientific Oversight Committee and Dr. Sabol is now serving as the co-chair of the Membership Committee. Learn more about these members and their expertise by reading their biographies below.

Boaz Mendzelevski, MD: 

Dr. Medzelevski is a consultant cardiologist at Cardiac Safety Consultants Ltd.

He received his degree in medicine from the Ben-Gurion University Medical School and his board certification in internal medicine from the Soroka Medical Center, both located in Beer-Sheva, Israel. He then obtained his board certification in cardiology from the Shaare-Zedek Medical Centre in Jerusalem, Israel. He completed further training in interventional cardiology and electrophysiology at the Royal Brompton Hospital and the National Heart and Lung Institute in London, UK.

Dr. Mendzelevski co-founded the first European pharmaceutical research ECG core laboratory, Cardiac Alert Ltd, in London, UK. It was later acquired by Quintiles, now known as IQVIA. He helped relocate and reinstate the lab in Mumbai, India, where it still operates today. Dr. Mendzelevski later joined Covance and launched its European Cardiac Safety Services group and, after the Covance ECG lab was divested, he joined Medifacts International, later becoming a part of the BioClinica organization, as Vice President of Cardiology.

Currently, Dr. Mendzelevski is focusing on his work as a cardiology consultant to the pharmaceutical and biotechnology industry and provides expert input regarding cardiovascular safety issues in drug development. He is also very active at the Drug Information Association (DIA) and chaired numerous DIA cardiac safety conferences and workshops in the United States, Europe, and Asia (Japan and China). He is a regular speaker and chair at other industry and scientific meetings and has authored numerous peer reviewed publications.

Anupam Agarwal, MD, MPH: 

Dr. Agarwal is a cardiologist with over two decades of experience in treating patients and clinical research in academia in the United States. In the early 90s Dr. Agarwal worked at the Myocardial Infarction Triage and Intervention (MITI) registry with Douglas Weaver at the University of Washington, Seattle. In 2004-2005, he was associate director of Angiography Core Lab at TIMI Study Group at Brigham and Women’s Hospital. Over the span of his career, he was involved with research in genetics of hypertension, drug eluted coronary stents, and drug trials in many therapeutic areas including cardiovascular, respiratory, anti-inflammatory, GI, oncology, and Alzheimer’s disease. Dr. Agarwal has worked in the pharmaceutical industry for more than 11 years (GlaxoSmithKline, Pfizer, Gilead). He is currently the head of the Global Clinical Safety & Pharmacovigilance at Zogenix Inc., a pharmaceutical company developing therapies for rare diseases and central nervous system disorders.

Dr. Agarwal holds a medical degree from the GSVM Medical College, Kanpur, India and a Master of Public Health degree from the Harvard School of Public Health.

Mary Beth Sabol, MD, FACC, BSN: 

Dr. Sabol is a cardiologist with experience in both academic medicine and industry. In the early 2000s, she was a Clinical Assistant Professor of Medicine at the hospital of the University of Pennsylvania and was Assistant Director of the Cardiovascular Nuclear Stress Lab. She subsequently joined Wyeth, then Pfizer, and worked in several different functional areas, including Medical Affairs as the Cardiovascular Therapeutic Area Head, Clinical Research & Development, and then Clinical and Post-Marketing Safety. Her experience includes working in multiple therapeutic areas, including cardiovascular, metabolic, endocrine, infectious diseases and transplantation. Since joining GSK in early 2011, Dr. Sabol has worked in Global Clinical Safety and Pharmacovigilance. She led the development and implementation of eCRFs for cardiovascular events and death to standardize data collection across clinical trials internally within GSK and then subsequently led a similar working group on behalf of CSRC. She is the GSK Clinical Safety representative to PhRMA. Within GSK, she co-chairs the Cardiology Safety Panel and is a member of the QT Safety Panel, the Non-Clinical Cardiovascular Safety Panel, the Central Safety Department Operations Board, and the Safety Advisory Forum.

Dr. Sabol received her BS degree in nursing from the University of Delaware and MD degree from Jefferson Medical College. She completed her residency in internal medicine from the University of Massachusetts Medical Center and fellowships in cardiovascular medicine from Thomas Jefferson University Hospital and in Nuclear Medicine from the Hospital of the University of Pennsylvania.

CSRC Heart Failure Think Tank Planning Committee Opportunities Available

The CSRC is currently recruiting planning committee members to help organize and prepare for the upcoming think tank, “Evaluation of Heart Failure as an Off-target Event in Development of Diabetes and other Non-cardiac Drugs.”

“The evaluation of heart failure, both at baseline and incident cases, in the context of drug development remains challenging. The CSRC will be holding a think tank to explore the current landscape of heart failure ascertainment (baseline, incident, severity, events, and therapy) within the context of drug development in order to inform strategies for evaluation of heart failure during clinical trials both in future trials and in the post marketing arena,” said Dr. Jonathan Seltzer, president of ACI Clinical.

“As advances in therapies for various cardiovascular and non-cardiovascular diseases are being pursued at unprecedented levels, and population age and risk factor burdens increase, the number of patients in clinical trials who are at risk for or who manifest heart failure also continues to rise. New therapeutic approaches, including those targeting non-cardiac diseases such as cancer and diabetes, often affect vasculature, myocytes, renal function, or neurohormonal systems, which may influence the development or progression of heart failure in this population.”

If you are interested in joining the planning committee for this event, please contact us at cardiacsafety@duke.dm.edu.