The Experts below are selected from a list of 11244 Experts worldwide ranked by ideXlab platform
Donald E Cutlip - One of the best experts on this subject based on the ideXlab platform.
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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
American Heart Journal, 2017Co-Authors: Jonathan H Seltzer, Ted Heise, Peter E Carson, Daniel A Canos, Jo Carol Hiatt, Pascal Vranckx, Thomas Christen, Donald E CutlipAbstract: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), end point 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.
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value based hypothesis testing for cardiac Device Clinical Trials a pathway for accelerated reimbursement decisions
Circulation-cardiovascular Interventions, 2016Co-Authors: Donald E Cutlip, Daniel B KramerAbstract:Medical Device sponsors seeking to introduce innovative Devices in the United States must clear 2 regulatory hurdles. First, they must provide evidence demonstrating reasonable assurance of safety and effectiveness for adjudication and marketing approval by the Food and Drug Administration (FDA). Second, they must apply for reimbursement coverage through the Centers for Medicare and Medicaid Services (CMS). This second step is based on a different metric that requires demonstration that treatment using the Device is reasonable and necessary. Typically, decisions for reimbursement coverage lag well behind the FDA approval for marketing and may result in substantial delays to the availability of some novel therapies. In interventional cardiology, recent examples include a 6-month wait for a coverage with evidence decision after an already-belated FDA approval for the first transcatheter aortic valve and the only recently final reimbursement decision for the Watchman (Boston Scientific, Marlborough, MA) left atrial occlusion Device, almost 11 months after FDA-marketing approval. These delays arise in part from the incomplete overlap between safety/effectiveness and reasonable/necessary standards. Pivotal Clinical Trials are typically designed to support the safety and effectiveness assessment but may lack data necessary to characterize reasonable and necessary. Although reasonable and necessary does not have a strict regulatory definition, it connotes added healthcare value, defined as improved quality of outcome relative to cost.1,2 Harmonizing these goals in Clinical trial designs will accelerate the Clinical introduction of important new technology. This study will examine the limitations of current cardiac Device Clinical Trials and explore methods for incorporating value-based hypotheses into the design of these studies. Given the frequent requirement for active treatment controls and the difficulty in proving superiority of incremental changes in new Devices, noninferiority trial designs have become the mainstay of cardiac Device Clinical Trials. In addition to demonstrating that a new Device …
Thuylinh Nguyen - One of the best experts on this subject based on the ideXlab platform.
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analysis and reporting of sex differences in phase iii medical Device Clinical Trials how are we doing
Journal of Womens Health, 2013Co-Authors: Martha R Nolan, Thuylinh NguyenAbstract:Abstract Over the past decade, the scientific community has begun to recognize the importance of biological sex differences in disease pathology, diagnosis, prevention, and treatment; however, the practice of sex-specific analysis and reporting is not integrated as standard practice by either our federal health agencies or by major medical journals. Despite the reforms of 20 years ago and the general inclusion of women in drug Clinical Trials, we have yet to see data routinely analyzed and reported by sex. Major journals are not requiring it, and large, publicly available datasets, such as ClinicalTrials.gov, are not systematically collecting and pointing to it. However, federal health databases and medical journals have the potential to impact progress in sex-specific analysis and reporting. We conducted a search on ClinicalTrials.gov for phase III Device Clinical Trials and assessed their practice of sex differences evaluation. Reporting of Clinical trial results by sex will maximize scientific value of...
Martha R Nolan - One of the best experts on this subject based on the ideXlab platform.
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analysis and reporting of sex differences in phase iii medical Device Clinical Trials how are we doing
Journal of Womens Health, 2013Co-Authors: Martha R Nolan, Thuylinh NguyenAbstract:Abstract Over the past decade, the scientific community has begun to recognize the importance of biological sex differences in disease pathology, diagnosis, prevention, and treatment; however, the practice of sex-specific analysis and reporting is not integrated as standard practice by either our federal health agencies or by major medical journals. Despite the reforms of 20 years ago and the general inclusion of women in drug Clinical Trials, we have yet to see data routinely analyzed and reported by sex. Major journals are not requiring it, and large, publicly available datasets, such as ClinicalTrials.gov, are not systematically collecting and pointing to it. However, federal health databases and medical journals have the potential to impact progress in sex-specific analysis and reporting. We conducted a search on ClinicalTrials.gov for phase III Device Clinical Trials and assessed their practice of sex differences evaluation. Reporting of Clinical trial results by sex will maximize scientific value of...
Fred W Lindemans - One of the best experts on this subject based on the ideXlab platform.
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adverse events with transvenous implantable cardioverter defibrillators a prospective multicenter study
Circulation, 1998Co-Authors: Marten Rosenqvist, Thorsten Beyer, M Block, Karel Den Dulk, Jaak Minten, Fred W LindemansAbstract:Background—A newly developed classification system relates adverse events to the surgical procedure or the function of the implantable defibrillator. Methods and Results—Adverse events were monitored during prospective Clinical evaluation of the Medtronic model 7219 Jewel ICD and were classified according to the definitions of the ISO 14155 standard for Device Clinical Trials into 3 groups: severe and mild Device-related and severe non–Device-related adverse events. In addition, events were related to the surgical procedure, treatment with the Device, or cardiac function. Seven hundred seventy-eight patients were followed up for an average of 4.0 months after ICD implantation. In total, 356 adverse events were observed in 259 patients. At 1, 3, and 12 months after ICD implantation, 99%, 98%, and 97% of the patients, respectively, survived; 95%, 93%, and 92%, respectively, were free of surgical reintervention; and 79%, 68%, and 51%, respectively, were free of any adverse event. Twenty patients died: 6 deat...
H Kulkarni - One of the best experts on this subject based on the ideXlab platform.
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occlusion of congenital ventricular septal defects by the buttoned Device buttoned Device Clinical Trials international register
Heart, 1997Co-Authors: E B Sideris, Kevin Walsh, J L Haddad, C R Chen, Seng Gen Ren, H KulkarniAbstract:OBJECTIVES: To study the feasibility of congenital ventricular septal defect occlusion by the buttoned Device and to establish guidelines for its safe and effective application. DESIGN: A descriptive study of all patients with a congenital ventricular septal defect undergoing transcatheter occlusion with the buttoned Device, from March 1994 to May 1995. These patients were otherwise candidates for elective surgery at their institutions because they had persistence of a significant shunt (Qp:Qs = 1.5-2.1:1, median = 1.7), with left ventricular enlargement and/or symptoms, although their systolic pulmonary artery pressure was invariably normal (20-28 mm Hg, median = 25). The angiographic diameter of the defect ranged from 2.5 to 14 mm (median 6 mm). SETTING: A multi-institutional study. PATIENTS: Out of 25 cases attempted, 18 children and adults aged 4-35 years had Devices implanted. Fifteen of these patients had membranous ventricular septal defects and three had muscular defects. All patients with a membranous ventricular septal defect had an associated aneurysm of the membranous septum. INTERVENTIONS: The buttoned Device was introduced either directly or, in the last 12 cases, over a wire bridging the femoral artery and the femoral or jugular vein; the Devices were delivered through 7-9 French (F) long sheaths. A membranous defect was regarded as suitable for Device closure if the distance from the centre of the defect to the insertion of the right coronary aortic valve leaflet was more than 50% of the size of the required Device. The Device was guided by echocardiography and fluoroscopy. All muscular defects were corrected through the right jugular vein and all membranous ones through the femoral vein. RESULTS: All 18 patients underwent initial successful implantation of the Device. In thirteen patients the shunts were completely occluded and in the remaining five there were trivial residual shunts. In two patients with membranous ventricular septal defects a change from the original position was noticed at two weeks; mild aortic regurgitation developed in one and the murmur recurred in the other; the Devices had to be removed surgically. One patient developed transient third degree atrioventricular block during implantation; no tricuspid regurgitation was observed. CONCLUSION: Clinical occlusion of congenital ventricular septal defects was achieved in 16 out of the 18 attempted cases (13 full occlusions). Membranous ventricular septal defect occlusion can be effective and safe if patients and Device sizes are carefully selected.