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.)