Clinical Endpoints Adjudication News
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Clinical Endpoints Adjudication News
Endpoint Adjudication articles, news and resources
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Exl Endpoint Adjudication Event 2016 - Philadelphia. The slides by Terry Katz (Merck Animal Health) - Improve Data Flow with Proven Data Capture Techniques and Transfer Protocols

Exl Endpoint Adjudication Event 2016 - Philadelphia. The slides by Terry Katz (Merck Animal Health) - Improve Data Flow with Proven Data Capture Techniques and Transfer Protocols | Clinical Endpoints Adjudication News | Scoop.it
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British Journal of Cancer - Abstract of article: Impact of cause of death adjudication on the results of the European prostate cancer screening trial

The BJC is owned by Cancer Research UK, a charity dedicated to understanding the causes, prevention and treatment of cancer and to making sure that the best new treatments reach patients in the clinic as quickly as possible. The journal reflects these aims. It was founded more than fifty years ago and, from the start, its far-sighted mission was to encourage communication of the very best cancer research from laboratories and clinics in all countries. The breadth of its coverage, its editorial independence and it consistent high standards, have made BJC one of the world's premier general cancer journals. Its increasing popularity is reflected by a steadily rising impact factor.
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RESPECT final analysis: PFO closure reduces risk for recurrent stroke

WASHINGTON — Final results of the RESPECT trial showed that percutaneous patent foramen ovale closure reduced the risk for recurrent stroke compared with guideline-directed medical therapy alone over a mean follow-up of 6 years. The new data, presented at TCT 2016, come on the heels of FDA approval of the device studied (Amplatzer PFO Occluder, St. Jude Medical). In late October, the FDA
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...RESPECT was a randomized, event-driven, open-label trial with blinded endpoint adjudication.

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For acute MI patients, readmissions for unstable angina or unplanned revascularization worsen outcomes

Within one year of having an acute MI, patients who were rehospitalized for unplanned coronary revascularization or unstable angina had statistically and clinically significant decreases in disease-specific and global health status measures, according to a registry analysis.
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The study had a few limitations, according to the researchers, including that they only included rehospitalizations that were available for adjudication.

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When a stent is not a stent is not a stent: Fallacies in govt’s drive to bring down its cost 

When a stent is not a stent is not a stent: Fallacies in govt’s drive to bring down its cost  | Clinical Endpoints Adjudication News | Scoop.it
Earlier this year in July, government regulators brought ‘stents’ under the National List of Essential Medicines, a much-needed initiative to make this device more accessible and affordable to the Indian population. Coronary artery diseas
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In the US, FDA approval requires long-term animal safety data plus one-year safety and effectiveness data in a large number of patients with follow-up continued to five years. These data are collected through large multi-centre randomised, clinical trials with rigorous statistical rationale, independent safety monitoring, adverse event adjudication, and core laboratory image interpretation. In India, approval of a stent requires only non-randomised safety data from a mere 100 patients for six months.

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Endpoint Adjudication Charter Template - What Should Be Included? An Overview

Endpoint Adjudication Charter Template - What Should Be Included? An Overview | Clinical Endpoints Adjudication News | Scoop.it
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the working group is moving forward...

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Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT)

Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT) | Clinical Endpoints Adjudication News | Scoop.it
Adjud
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Meeting at the Endpoint Adjudication Forum - October 19-20, 2016 Philadelphia

Meeting at the Endpoint Adjudication Forum - October 19-20, 2016 Philadelphia | Clinical Endpoints Adjudication News | Scoop.it
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Development of a clinical prediction score for congestive heart failure diagnosis in the emergency care setting: The Brest score | Read by QxMD

Development of a clinical prediction score for congestive heart failure diagnosis in the emergency care setting: The Brest score | Read by QxMD | Clinical Endpoints Adjudication News | Scoop.it
Great article: Development of a clinical prediction score for congestive heart failure diagnosis in th... https://t.co/ddQyAseNXQ
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During the derivation phase, variables associated with acute congestive heart failure were included in a multivariate regression model. Logistic regression coefficients were used to assign scoring points to each variable. During the validation phase, every diagnosis was confirmed by an independent adjudication committee.

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Amarin’s REDUCE-IT Cardiovascular Outcomes Study of Vascepa to Continue as Planned at Recommendation of Independent Data Monitoring Committee

Amarin’s REDUCE-IT Cardiovascular Outcomes Study of Vascepa to Continue as Planned at Recommendation of Independent Data Monitoring Committee | Clinical Endpoints Adjudication News | Scoop.it
In accordance with the study protocol, the first interim efficacy analysis was performed after adjudication of approximately 60% of the target 1,612 aggregate primary cardiovascular events occurred within the study.
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Merck & Co. drops osteoporosis drug - Pharmaphorum

Merck & Co. drops osteoporosis drug - Pharmaphorum | Clinical Endpoints Adjudication News | Scoop.it
Merck & Co has dropped its odanacatib osteoporosis drug and will not seek a filing, after phase 3 results showed an increased risk of stroke.
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Echocardiographic Predictors of Sudden Cardiac Death
The Atherosclerosis Risk in Communities Study and Cardiovascular Health Study

Mitral annular calcification 2nd best echo finding (behind reduced LVEF) for predicting #SCD https://t.co/xi7BjsDo8x

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The main outcome was physician-adjudicated SCD Sudden cardiac death.

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Left Ventricular Geometry and Risk of Sudden Cardiac Arrest in Patients With Severely Reduced Ejection Fraction

Left Ventricular Geometry and Risk of Sudden Cardiac Arrest in Patients With Severely Reduced Ejection Fraction | Clinical Endpoints Adjudication News | Scoop.it
Journal of the American Heart Association (JAHA) is an authoritative, peer-reviewed Open Access journal focusing on cardiovascular and cerebrovascular disease
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[...] A 3‐physician review of available medical records/autopsy reports was performed for adjudication of SCA [...]

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Portola Announces Three Phase III APEX Substudy Results Showing Further Benefits Of Treating Acute Medically Ill Patients With Extended Duration

Portola Announces Three Phase III APEX Substudy Results Showing Further Benefits Of Treating Acute Medically Ill Patients With Extended Duration | Clinical Endpoints Adjudication News | Scoop.it
Stroke events were adjudicated by an independent blinded-event adjudication committee and assessed through last patient contact
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...Stroke events were adjudicated by an independent blinded-event adjudication committee and assessed through last patient contact

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Can routine healthcare data be used to efficiently and reliably follow-up participants in renal trials: analyses using linked data from 2 large renal trials — Nuffield Department of Population Health

Can routine healthcare data be used to efficiently and reliably follow-up participants in renal trials: analyses using linked data from 2 large renal trials — Nuffield Department of Population Health | Clinical Endpoints Adjudication News | Scoop.it
Study with us: #PhD - using #EHR for efficient #clinicaltrials in #CKD @Oxford_NDPH @OxfordMedSci @UniofOxford https://t.co/6TYFGrWgjl
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2017 DPhil research projects
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Results From U.S. Pivotal Trial Show That Sentinel Cerebral Protection System Protects Patients During TAVR | Journal of Invasive Cardiology

Results From U.S. Pivotal Trial Show That Sentinel Cerebral Protection System Protects Patients During TAVR | Journal of Invasive Cardiology | Clinical Endpoints Adjudication News | Scoop.it
Each of these detailed imaging and clinical assessments were reviewed, adjudicated and reported by independent academic core labs and Clinical Events Committees (CEC).
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...Each of these detailed imaging and clinical assessments were reviewed, adjudicated and reported by independent academic core labs and Clinical Events Committees (CEC).

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Dietary Marine ω-3 Fatty Acids and Incident Sight-Threatening Retinopathy in Middle-Aged and Older Individuals With Type 2 Diabetes: Prospective In... - PubMed - NCBI

Dietary Marine ω-3 Fatty Acids and Incident Sight-Threatening Retinopathy in Middle-Aged and Older Individuals With Type 2 Diabetes: Prospective In... - PubMed - NCBI | Clinical Endpoints Adjudication News | Scoop.it
JAMA Ophthalmol. 2016 Oct 1;134(10):1142-1149. doi: 10.1001/jamaophthalmol.2016.2906.
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The main outcome was incident DR requiring laser photocoagulation, vitrectomy, and/or antiangiogenic therapy confirmed by an external adjudication committee.

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Relationships Between Caffeine Intake and Risk for Probable Dementia or Global Cognitive Impairment: The Women’s Health Initiative Memory Study

Relationships Between Caffeine Intake and Risk for Probable Dementia or Global Cognitive Impairment: The Women’s Health Initiative Memory Study | Clinical Endpoints Adjudication News | Scoop.it
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...The central adjudication committee consists of three board-certified specialists (two neurologists and one geriatric psychiatrist) with extensive experience in dementia, who reviewed medical records to inform the diagnosis....

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Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: proto...

Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: proto... | Clinical Endpoints Adjudication News | Scoop.it
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Medtronic touts low CD-TLR rates, strong durability in 3-year In.Pact Admiral DCB study | VIVA 2016 Roundup

Medtronic touts low CD-TLR rates, strong durability in 3-year In.Pact Admiral DCB study | VIVA 2016 Roundup | Clinical Endpoints Adjudication News | Scoop.it
Medtronic (NYSE:MDT) this week released data from 2 clinical studies evaluating its In.Pact Admiral drug-coated balloon for treating claudication and restenosis, touting sustained durability at 3-years. Results were presented at the Vascular Interventional Advances 2016 conference in Las Vegas this week. 3-year outcomes from the In.Pact SFA trial showed Medtronic’s balloon had long-term clinical benefit superior to plain balloon angioplasty, […]
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“When evaluating quality of data, it’s important to consider the clinical rigor built into the study design,” Medtronic aortic & peripheral vascular biz medical director Dr. Mark Turco said. “This is why Medtronic has made significant investments in independent adjudication for the In.Pact clinical program to deliver unquestionable results

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Endpoint Adjudication Forum - October 19-20, 2016 - Philadelphia: meet Ethical there

Endpoint Adjudication Forum - October 19-20, 2016 - Philadelphia. Ethical Director Mimmo Garibbo will be attending the conference to meet our customers, colleagues and partners

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Anyone interested to meet Ethical eAdjudication there can write us to book a time slot with our Director Mimmo Garibbo.

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Low Heart Rate Variability in a 2-Minute Electrocardiogram Recording Is Associated with an Increased Risk of Sudden Cardiac Death in the General Population: The Atherosclerosis Risk in Communities ...

Low heart rate variability (HRV) has been linked to increased total mortality in the general population; however, the relationship between low HRV and sudden cardiac death (SCD) is less well-characterized. The goal of this study was to evaluate the relationship between low HRV and SCD in a community-based cohort. Our cohort consisted of 12,543 participants from the Atherosclerosis Risk in Communities (ARIC) study. HRV measures were derived from 2-minute electrocardiogram recordings obtained during the baseline exam (1987–89). Time domain measurements included the standard deviation of all normal RR intervals (SDNN) and the root mean squared successive difference (r-MSSD). Frequency domain measurements included low frequency power (LF) and high frequency (HF) power. During a median follow-up of 13 years, 215 SCDs were identified from physician adjudication of all coronary heart disease deaths through 2001. In multivariable adjusted Cox proportional hazards models, each standard deviation decrement in SDNN, LF, and HF were associated with 24%, 27% and 16% increase in SCD risk, respectively. Low HRV is independently associated with increased risk of SCD in the general population.
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Algorithms for the Capture and Adjudication of Prevalent and Incident Diabetes in UK Biobank. - PubMed - NCBI

Algorithms for the Capture and Adjudication of Prevalent and Incident Diabetes in UK Biobank. - PubMed - NCBI | Clinical Endpoints Adjudication News | Scoop.it
PLoS One. 2016 Sep 15;11(9):e0162388. doi: 10.1371/journal.pone.0162388.
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Endpoint Adjudication Charter Template - What Should Be Included? An Overview - Draft Paper by the Endpoint Adjudication Linkedin Working Group

Endpoint Adjudication Charter Template - What Should Be Included? An Overview - Draft Paper by the Endpoint Adjudication Linkedin Working Group | Clinical Endpoints Adjudication News | Scoop.it
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Anyone interested can contribute by subscribing our Linkedin Group

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Switzerland is European leader in workforce in the Life Sciences industry - Blog | i-net

Switzerland is European leader in workforce in the Life Sciences industry - Blog | i-net | Clinical Endpoints Adjudication News | Scoop.it
What makes a country in Europe attractive to foreign Life Sciences companies? KPMG Switzerland (in collaboration with Venture Valuation) has released its 2015 Report on «Site Selection for Life Sciences Companies in Europe». According to KPMG, the report offers facts and figures for international Life Sciences companies looking to expand, restructure or consolidate their activities …
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