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https://www.readbyqxmd.com/read/29436244/improving-multiple-sclerosis-management-and-collecting-safety-information-in-the-real-world-the-msds3d-software-approach
#1
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
#2
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
#3
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...
January 26, 2018: Thrombosis Research
https://www.readbyqxmd.com/read/29337204/the-positive-impacts-of-real-world-data-on-the-challenges-facing-the-evolution-of-biopharma
#4
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 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...
January 11, 2018: Drug Discovery Today
https://www.readbyqxmd.com/read/29232466/real-world-evidence-in-the-treatment-of-ovarian-cancer
#5
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
#6
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.
December 6, 2017: 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
#7
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 were pooled from 15 RCTs (N = 5542), 8 RWE studies (N = 1397) for Val/Aml; and 2 RCTs (N = 804), 5 RWE studies (N = 9380) for Val/Aml/HCTZ...
December 6, 2017: 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
#8
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 were published to date. The aim of this systematic review was to summarize 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...
October 25, 2017: 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
#9
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 4908 patients (IDB) and 1134 patients (RWE) with T2D treated with any insulin regimen with a baseline and ≥1 postbaseline HbA1c...
October 24, 2017: 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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
https://www.readbyqxmd.com/read/28597407/resistance-wheel-exercise-from-mid-life-has-minimal-effect-on-sciatic-nerves-from-old-mice-in-which-sarcopenia-was-prevented
#18
Vidya S Krishnan, Zoe White, Jessica R Terrill, Stuart I Hodgetts, Melinda Fitzgerald, Tea Shavlakadze, Alan R Harvey, Miranda D Grounds
The ability of resistance exercise, initiated from mid-life, to prevent age-related changes in old sciatic nerves, was investigated in male and female C57BL/6J mice. Aging is associated with cellular changes in old sciatic nerves and also loss of skeletal muscle mass and function (sarcopenia). Mature adult mice aged 15 months (M) were subjected to increasing voluntary resistance wheel exercise (RWE) over a period of 8 M until 23 M of age. This prevented sarcopenia in the old 23 M aged male and female mice...
October 2017: Biogerontology
https://www.readbyqxmd.com/read/28530524/is-real-world-evidence-used-in-p-t-monographs-and-therapeutic-class-reviews
#19
Jason T Hurwitz, Mary Brown, Jennifer S Graff, Loretta Peters, Daniel C Malone
BACKGROUND: Payers are faced with making coverage and reimbursement decisions based on the best available evidence. Often these decisions apply to patient populations, provider networks, and care settings not typically studied in clinical trials. Treatment effectiveness evidence is increasingly available from electronic health records, registries, and administrative claims. However, little is known about when and what types of real-world evidence (RWE) studies inform pharmacy and therapeutic (P&T) committee decisions...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28359391/study-types-and-reliability-of-real-world-evidence-compared-with-experimental-evidence-used-in-polish-reimbursement-decision-making-processes
#20
N Wilk, N Wierzbicka, I Skrzekowska-Baran, P Moćko, J Tomassy, K Kloc
OBJECTIVES: The aim of this study was to identify the relationship and impact between Real World Evidence (RWE) and experimental evidence (EE) in Polish decision-making processes for the drugs from selected Anatomical Therapeutic Chemical (ATC) groups. STUDY DESIGN: Descriptive study. METHODS: A detailed analysis was performed for 58 processes from five ATC code groups in which RWE for effectiveness, or effectiveness and safety were cited in Agency for Health Technology Assessment and Tariff System's (AOTMiT) documents published between January 2012 and September 2015: Verification Analysis of AOTMiT, Statement of the Transparency Council of AOTMiT, and Recommendation of the President of AOTMiT...
April 2017: Public Health
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