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https://www.readbyqxmd.com/read/29659663/real-world-evidence-for-regulatory-decisions-concomitant-administration-of-zoster-vaccine-live-and-pneumococcal-polysaccharide-vaccine
#1
Katia Bruxvoort, Lina S Sy, Yi Luo, Hung Fu Tseng
The US Food and Drug Administration is charged with expanding the use of real world evidence (RWE) for regulatory decisions. As a test case for RWE to support regulatory decisions, we present the scenario of concomitant vaccination with zoster vaccine live (ZVL) and 23-valent pneumococcal polysaccharide vaccine (PPSV23). The prescribing information states that these vaccines should not be given concurrently, based on a small trial using varicella zoster virus antibody levels as a correlate of ZVL efficacy, even though ZVL protects against herpes zoster via cell-mediated immunity...
April 11, 2018: American Journal of Epidemiology
https://www.readbyqxmd.com/read/29628883/achieving-accurate-automatic-sleep-staging-on-manually-pre-processed-eeg-data-through-synchronization-feature-extraction-and-graph-metrics
#2
Panteleimon Chriskos, Christos A Frantzidis, Polyxeni T Gkivogkli, Panagiotis D Bamidis, Chrysoula Kourtidou-Papadeli
Sleep staging, the process of assigning labels to epochs of sleep, depending on the stage of sleep they belong, is an arduous, time consuming and error prone process as the initial recordings are quite often polluted by noise from different sources. To properly analyze such data and extract clinical knowledge, noise components must be removed or alleviated. In this paper a pre-processing and subsequent sleep staging pipeline for the sleep analysis of electroencephalographic signals is described. Two novel methods of functional connectivity estimation (Synchronization Likelihood/SL and Relative Wavelet Entropy/RWE) are comparatively investigated for automatic sleep staging through manually pre-processed electroencephalographic recordings...
2018: Frontiers in Human Neuroscience
https://www.readbyqxmd.com/read/29566840/real-world-evidence-useful-in-the-real-world-of-us-payer-decision-making-how-when-and-what-studies
#3
Daniel C Malone, Mary Brown, Jason T Hurwitz, Loretta Peters, Jennifer S Graff
OBJECTIVES: To examine how real-world evidence (RWE) is currently perceived and used in managed care environments, especially to inform pharmacy and therapeutic (P&T) committee decisions, to assess which study factors (e.g., data, design, and funding source) contribute to RWE utility in decisions, and to identify barriers to consideration of RWE studies in P&T decision making. METHODS: We conducted focus groups/telephone-based interviews and surveys to understand perceptions of RWE and assess awareness, quality, and relevance of two high-profile examples of published RWE studies...
March 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/29436244/improving-multiple-sclerosis-management-and-collecting-safety-information-in-the-real-world-the-msds3d-software-approach
#4
Rocco Haase, Maria Wunderlich, Anja Dillenseger, Raimar Kern, Katja Akgün, Tjalf Ziemssen
For safety evaluation, randomized controlled trials (RCTs) are not fully able to identify rare adverse events. The richest source of safety data lies in the post-marketing phase. Real-world evidence (RWE) and observational studies are becoming increasingly popular because they reflect usefulness of drugs in real life and have the ability to discover uncommon or rare adverse drug reactions. Areas covered: Adding the documentation of psychological symptoms and other medical disciplines, the necessity for a complex documentation becomes apparent...
February 13, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29415784/peer-reviewed-journal-editors-views-on-real-world-evidence
#5
Elisabeth M Oehrlein, Jennifer S Graff, Eleanor M Perfetto, C Daniel Mullins, Robert W Dubois, Chinenye Anyanwu, Eberechukwu Onukwugha
OBJECTIVES: Peer-review publication is a critical step to the translation and dissemination of research results into clinical practice guidelines, health technology assessment (HTA) and payment policies, and clinical care. The objective of this study was to examine current views of journal editors regarding: (i) The value of real-world evidence (RWE) and how it compares with other types of studies; (ii) Education and/or resources journal editors provide to their peer reviewers or perceive as needed for authors, reviewers, and editors related to RWE...
February 8, 2018: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/29407632/what-have-we-learned-from-real-world-noac-studies-in-venous-thromboembolism-treatment
#6
REVIEW
Jan Beyer-Westendorf
Venous thromboembolism (VTE) remains a substantial clinical and health-economic burden worldwide and effective anticoagulant treatment is necessary immediately after VTE is suspected to reduce short- and long-term VTE related morbidity and mortality. For decades, low molecular weight heparin (LMWH), fondaparinux and Vitamin K antagonists (VKAs) have been the standard of anticoagulant therapy for VTE patients but these treatment options had clinically relevant drawbacks and limitations. The introduction of non-VKA oral anticoagulants (NOACs) that specifically inhibit either thrombin or factor Xa have resolved many of these drawbacks because these new compounds exhibit a rapid onset and offset of action, fewer food and drug interactions and a predictable anticoagulant effect...
March 2018: Thrombosis Research
https://www.readbyqxmd.com/read/29337204/the-positive-impacts-of-real-world-data-on-the-challenges-facing-the-evolution-of-biopharma
#7
REVIEW
John Wise, Angeli Möller, David Christie, Dipak Kalra, Elia Brodsky, Evelina Georgieva, Greg Jones, Ian Smith, Lars Greiffenberg, Marie McCarthy, Michael Arend, Olivier Luttringer, Sebastian Kloss, Steve Arlington
Demand for healthcare services is unprecedented. Society is struggling to afford the cost. Pricing of biopharmaceutical products is under scrutiny, especially by payers and Health Technology Assessment agencies. As we discuss here, rapidly advancing technologies, such as Real-World Data (RWD), are being utilized to increase understanding of disease. RWD, when captured and analyzed, produces the Real-World Evidence (RWE) that underpins the economic case for innovative medicines. Furthermore, RWD can inform the understanding of disease, help identify new therapeutic intervention points, and improve the efficiency of research and development (R&D), especially clinical trials...
April 2018: Drug Discovery Today
https://www.readbyqxmd.com/read/29232466/real-world-evidence-in-the-treatment-of-ovarian-cancer
#8
E A Eisenhauer
Introduction: 'Real-world evidence (RWE)' refers to information on the utilization and outcome of new therapies and technologies in clinical practice. RWE may include single institution cohort studies, population-based health services studies, or (inter)national data on survival and mortality. This paper reviews RWE on the impact of treatment in ovarian cancer. Materials and methods: A literature review of publications addressing population level survival outcomes of new surgical and systemic treatment interventions in ovarian cancer was undertaken...
November 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29214638/harnessing-the-power-of-real-world-evidence-rwe-a-checklist-to-ensure-regulatory-grade-data-quality
#9
Rebecca A Miksad, Amy P Abernethy
The role of real-world evidence (RWE) in regulatory, drug development, and healthcare decision-making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real-world clinical decisions. Instead of remaining invisible, data from the >95% of cancer patients treated outside of clinical trials can help fill this void.
February 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29210288/efficacy-and-effectiveness-of-valsartan-amlodipine-and-valsartan-amlodipine-hydrochlorothiazide-in-hypertension-randomized-controlled-versus-observational-studies
#10
Jorge Sison, Rosa María Ríos Vega, Hu Dayi, Giovanni Bader, Patrick Brunel
OBJECTIVE: The aim of this post-hoc analysis was to compare the results from randomized controlled trials (RCTs) and real-world evidence (RWE) studies of valsartan/amlodipine (Val/Aml) and valsartan/amlodipine/hydrochlorothiazide (Val/Aml/HCTZ) in patients with uncontrolled hypertension (>140/90 mmHg). METHODS: Data was pooled from 15 RCTs (N = 5542) and 8 RWE studies (N = 1397) for Val/Aml; and 2 RCTs (N = 804) and 5 RWE studies (N = 9380) for Val/Aml/HCTZ...
March 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29077833/vedolizumab-in-ibd-lessons-from-real-world-experience-a-systematic-review-and-pooled-analysis
#11
Tal Engel, Bella Ungar, Diana E Yung, Shomron Ben-Horin, Rami Eliakim, Uri Kopylov
Background: Vedolizumab [VDZ] is an anti-integrin monoclonal antibody effective in ulcerative colitis [UC] and Crohn's disease [CD]. Several real-world experience [RWE] studies with VDZ have been published to date. The aim of this systematic review was to summarise the available real-life experience with VDZ. Methods: We performed a systematic review of the available RWE studies of VDZ in CD and UC. We performed a pooled analysis of the available efficacy and safety data for induction and maintenance treatment in adult cohorts...
January 24, 2018: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29065720/identifying-insulin-treatment-responders-with-a-composite-measure-beyond-hba1c-7-in-patients-with-type-2-diabetes
#12
Ignacio Conget, M Sue Kirkman, Dachuang Cao, Mayme Wong, Jesus Reviriego, David M Kendall
OBJECTIVES: Many insulin-treated patients with type 2 diabetes (T2D) do not reach hemoglobin A1c (HbA1c) < 7%, but have clinically relevant HbA1c reductions. Using an integrated database (IDB) of 53 insulin lispro clinical trials and a real-world evidence (RWE) database of T2D patients initiating insulin therapy, an expanded HbA1c measure was used to identify responders to insulin therapy. METHODS: Analysis included 4,908 patients (IDB) and 1,134 patients (RWE) with T2D treated with any insulin regimen with a baseline and ≥1 post-baseline HbA1c...
February 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28964430/good-practices-for-real-world-data-studies-of-treatment-and-or-comparative-effectiveness-recommendations-from-the-joint-ispor-ispe-special-task-force-on-real-world-evidence-in-health-care-decision-making
#13
Marc L Berger, Harold Sox, Richard J Willke, Diana L Brixner, Hans-Georg Eichler, Wim Goettsch, David Madigan, Amr Makady, Sebastian Schneeweiss, Rosanna Tarricone, Shirley V Wang, John Watkins, C Daniel Mullins
PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies...
September 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28955404/responsible-pricing-in-value-based-assessment-of-cancer-drugs-real-world-data-are-an-inevitable-addition-to-select-meaningful-new-cancer-treatments
#14
EDITORIAL
Wim van Harten, Maarten J IJzerman
Recently, NICE was given the task of governing the Cancer Drug Fund (CDF) in the UK as the latter was criticized for allowing too many insufficiently tested drugs to be covered [1, 2]. The CDF was initiated in 2012, but immediately received criticism from several health economists because of the rather strict coverage criteria that are commonly used by NICE for most other health services in the NHS. This led to questions about the use of different reimbursement criteria (why have a different fund otherwise?) for expensive cancer drugs...
2017: Ecancermedicalscience
https://www.readbyqxmd.com/read/28913966/good-practices-for-real-world-data-studies-of-treatment-and-or-comparative-effectiveness-recommendations-from-the-joint-ispor-ispe-special-task-force-on-real-world-evidence-in-health-care-decision-making
#15
Marc L Berger, Harold Sox, Richard J Willke, Diana L Brixner, Hans-Georg Eichler, Wim Goettsch, David Madigan, Amr Makady, Sebastian Schneeweiss, Rosanna Tarricone, Shirley V Wang, John Watkins, C Daniel Mullins
PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies...
September 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28882693/different-effects-of-running-wheel-exercise-and-skilled-reaching-training-on-corticofugal-tract-plasticity-in-hypertensive-rats-with-cortical-infarctions
#16
ChanJuan Zhang, Yan Zou, Kui Li, Chao Li, YingPing Jiang, Ju Sun, Ruifang Sun, HongMei Wen
The approaches that facilitate white matter plasticity may prompt functional recovery after a stroke. The effects of different exercise methods on motor recovery in stroke rats have been investigated. However, it is not clear whether their effects on axonal plasticity different. The aim of this study was to compare the effects of the forced running wheel exercise (RWE) and skilled reaching training (SRT) on axonal plasticity and motor recovery. Cortical infarctions were generated in stroke-prone renovascular hypertensive rats...
January 15, 2018: Behavioural Brain Research
https://www.readbyqxmd.com/read/28857631/practical-implications-of-using-real-world-evidence-rwe-in-comparative-effectiveness-research-learnings-from-imi-getreal
#17
Amr Makady, Heather Stegenga, Antonio Ciaglia, Thomas Pa Debray, Michael Lees, Michael Happich, Bettina Ryll, Keith Abrams, Rob Thwaites, Sarah Garner, Páll Jonsson, Wim Goettsch
In light of increasing attention towards the use of real-world evidence (RWE) in decision making in recent years, this commentary aims to reflect on the experiences gained in accessing and using RWE for comparative effectiveness research as a part of the Innovative Medicines Initiative GetReal Consortium and discuss their implications for RWE use in decision-making.
August 31, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/28776214/-real-world-evidence-benefits-and-limitations-in-multiple-sclerosis-research
#18
REVIEW
T Ziemssen, D Rothenbacher, J Kuhle, T Berger
BACKGROUND: Real-world evidence (RWE) expands the data obtained in randomized clinical trials (RCTs), which are based on both homogeneous selected patient groups and limited study durations, to long-term experiences in clinical routine. In particular, chronic diseases such as multiple sclerosis (MS) with both heterogeneous pathologies and a growing number of therapeutic options require a careful RWE-based assessment of long-term efficacy and safety parameters. OBJECTIVE: This review presents RWE data sources applied in MS research and discusses potential quality standards...
October 2017: Der Nervenarzt
https://www.readbyqxmd.com/read/28699769/deriving-more-value-from-rwe-to-ensure-timely-access-of-medicines-by-patients
#19
Sarah Wamala Andersson, Mattias Kyhlstedt
No abstract text is available yet for this article.
July 12, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/28661852/real-world-evidence-faces-some-real-world-challenges
#20
Thomas Reinke
RWE is a relatively new kid on the block. How exactly it will fit into the complicated world of cancer drug testing, approval, regulation, and marketing is uncertain. The randomized clinical trial has been the gold standard in oncology research for decades and will remain so for the foreseeable future.
May 2017: Managed Care
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