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.

Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration

Journal Journal of the American Medical Informatics Association
Authors Drozda, Joseph P.; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E.
Year Published 2017
Link to article

Abstract

OBJECTIVE: The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration’s informatics architecture.

METHODS: Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors.

RESULTS: The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model.

CONCLUSION: The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model.

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank

Journal Healthcare
Authors Terrie L. Reed, Joseph P. Drozda Jr., Kevin M. Baskinc, James Tcheng, Karen Conway, Natalia Wilson, Danica Marinac-Dabic, Theodore Heise, Mitchell W. Krucoff
Year Published 2016
Link to publication

Abstract

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.

Registry-Based Prospective, Active Surveillance of Medical-Device Safety

Journal New England Journal of Medicine (NEJM)
Authors Frederic S. Resnic, M.D., Arjun Majithia, M.D., Danica Marinac-Dabic, M.D., Ph.D., Susan Robbins, B.S., Henry Ssemaganda, M.D., Kathleen Hewitt, M.S.N., Angelo Ponirakis, Ph.D., Nilsa Loyo-Berrios, Ph.D., Issam Moussa, M.D., Joseph Drozda, M.D., Sharon-Lise Normand, Ph.D., and Michael E. Matheny, M.D., M.P.H.
Year Published 2017
Link to publication

Abstract

Background

The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI).

Methods

We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion.

Results

We analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015.

Conclusions

A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.)

 

Long-term Postprocedural Outcomes of Palliative Emergency Stenting vs Stoma in Malignant Large-Bowel Obstruction

Journal JAMA Surgery
Authors Abelson JS, Yeo HL, Mao J, Milsom JW, Sedrakyan A.
Year Published 2017
Link to publication

Abstract

This study investigated readmission, reoperation, and other outcomes following palliative stent or stoma operation for bowel obstruction due to colorectal cancer in New York State, both in-hospital and long-term (90 days and 1 year). It was found that patients living closer to high-volume centers were more likely to undergo a stenting procedure. Patients who underwent stenting had lower rates of in-hospital death and of procedural complications than those who underwent stoma creation. Patients who received stents also had a shorter average length of stay and were less likely to be discharged to a nursing or rehabilitation facility. However, patients undergoing stenting were more likely to receive another procedure in the following year, mostly a re-stenting procedure. Stenting is safe in patients who are to receive only palliative treatment for bowel obstruction when offered at high volume hospitals. Patients should be cautioned that they might receive another stenting in the following year.