Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium

Journal American Heart Journal
Authors Jonathan H Seltzer, MD, MA, MBA; Ted Heise, Phd, RAC; Peter Carson, MD; Daniel Canos, PhD, MPH; Jo Carol Hiatt, MD, MBA; Pascal Vranckx, MD, PhD; Thomas Christen, MD, PhD; Donald E Cutlip, MD
Year Published 2017
Link to article

Summary

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “The Role of Endpoint Adjudication in Medical Device Clinical Trials”. The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA’s White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), endpoint adjudication specialist groups, clinical research organizations, and active, academically based adjudicators.

The manuscript presents recommendations from the think tank regarding

(1) rationale for when adjudication is appropriate,

(2) best practices establishment and operation of a medical device adjudication committee and

(3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence.

Use of Endpoint Adjudication to Improve Quality and Validity – A CSRC White Paper in AHJ

Clinical Safety Research Consortium (CSRC) paper in the American Heart Journal (AHJ)

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing  evaluation: Rationale and best practices. A report from the cardiac safety research consortium

Authors

Jonathan H Seltzer, MD, MA, MBA
Ted Heise, Phd, RAC
Peter Carson, MD
Jo Carol Hiatt, MD, MBA
Pascal Vranckx, MD, PhD
Thomas Christen, MD, PhD
Donald E Cutlip, MD

Summary

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “The Role of Endpoint Adjudication in Medical Device Clinical Trials”. The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA’s White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), endpoint adjudication specialist groups, clinical research organizations, and active, academically based adjudicators.

The manuscript presents recommendations from the think tank regarding

(1) rationale for when adjudication is appropriate,

(2) best practices establishment and operation of a medical device adjudication committee and

(3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence.

(Am Heart J 2017;190:76-85.)

Medical Device Research at a Regional Health System

Journal Asian Hospital and Healthcare Management
Authors Joseph P Drozda and Timothy R Smith
Year Published 2014
Link to Publication – (PDF)

Abstract

In 2009, Mercy made the decision to embark on a research programme involving implanted medical devices by employing Unique Device Identifiers (UDIs). Mercy is a four-state regional health system headquartered in St. Louis, Missouri that serves communities in Arkansas, Kansas, Missouri, and Oklahoma through 40 hospitals ranging from small, critical access facilities to large tertiary medical centres. In addition, Mercy employs over 2,000 physicians specialised in multiple disciplines and generates in excess of US$4 billion annually.

Mercy’s Information Journey

In 2006, Mercy began implementing EpicCare (Epic, Verona, WI) Electronic Health Record (EHR) in all of the system’s hospitals and employed physician practices – a process that took over six years to complete which resulted in a ‘fully connected’ health system generating a significant amount of clinical data across the healthcare spectrum. Despite this success, Mercy continues to face challenges in turning these data into actionable information due in part to free-standing clinical and administrative databases such as those contained in the cardiac catheterisation laboratory (Cath Lab) software and the Enterprise Resource Planning (ERP) solution. These ‘data islands’ make it difficult to establish a comprehensive view of administrative, clinical processes and of patient outcomes necessary for Mercy leaders to manage in the changing healthcare environment created by US Affordable Care Act (ACA).

New Business Environment and Need for Actionable Information

As healthcare reforms proceed, Mercy must learn to deal with US Centers for Medicare and Medicaid Services (CMS) programmes such as value-based purchasing, and public reporting of hospital and physician performance, along with different delivery models, such as patient centered medical homes and Accountable Care Organisations (ACOs). Mercy’s Springfield ( Missouri), network is participating in CMS’s ACO programme building on experience gained from the network’s successes as part of the earlier CMS Physician Group Practice demonstration. Finally, CMS is also working on new reimbursement strategies meant ultimately to replace fee for service. These include shared savings; bundled payments; and, potentially, monthly payments per assigned beneficiary (capitation). All of these changes will require an in-depth understanding of both the clinical and administrative aspects of the business and how the two interrelate.