Management of Atrial Fibrillation: Translating Clinical Trial Data into Clinical Practice

2011 ◽  
Vol 124 (1) ◽  
pp. 4-14 ◽  
Author(s):  
Kim A. Eagle ◽  
David S. Cannom ◽  
David A. Garcia
2016 ◽  
Vol 111 ◽  
pp. S324-S325
Author(s):  
Sunanda V. Kane ◽  
Anita Afzali ◽  
Doug Wolf ◽  
Ira Shafran ◽  
Matthew A. Ciorba ◽  
...  

Neurology ◽  
2002 ◽  
Vol 58 (Issue 12, Supplement 7) ◽  
pp. S6-S12 ◽  
Author(s):  
T. A. Glauser

2018 ◽  
Vol 29 (10) ◽  
pp. 1011-1013
Author(s):  
Don E Smith ◽  
Merrion Tom ◽  
Bruce H Bowden

The transition of clinical trial data to changes in routine clinical practice is often a slow process. We describe a rapid transition of patients from one form of antiviral therapy to a modified and potentially safer version that can occur quickly when there are no financial or organisational restrictions on the prescribers.


2019 ◽  
Vol 35 (S1) ◽  
pp. 53-53
Author(s):  
Adam Hall ◽  
Lok Wan Liu ◽  
Richard Macaulay ◽  
Sean Walsh

IntroductionThe Early Access to Medicines Scheme (EAMS) aims to provide access to medicines prior to market authorization for patients with severe, life-threatening diseases who do not have adequate treatment options. An EAMS designation enables the potential collection of United Kingdom-specific real world evidence (RWE) prior to health technology assessment (HTA) by the National Institute for Health and Care Excellence (NICE). This research evaluates whether RWE is being gathered through the EAMS and utilized to support HTA submissions.MethodsAll EAMS designations as of 7 November 2018 were identified from the Medicines and Healthcare products Regulatory Agency website. For products with final NICE guidance, all publicly-available NICE documentation was reviewed.ResultsSixteen product and indication pairings with an EAMS designation were identified, with 12 having received final NICE guidance (11 were recommended, 3 were recommended for temporary reimbursement via the Cancer Drugs Fund, and 2 were not recommended). Of the 11 recommended products, seven had references to the number of patients or sites with product access through the EAMS, but only one (dupilumab for atopic dermatitis) had detailed data collected during the EAMS period. The manufacturer of dupilumab reported baseline demographics and disease characteristics from a cohort of 35 patients treated under the EAMS to inform the generalizability of trial populations for clinical practice. Follow-up results from this cohort demonstrated that real-world data on dupilumab effectiveness was comparable with the clinical trial data, despite a higher proportion of patients in the real-world cohort receiving immunosuppressant therapy, which makes improvements in efficacy harder to achieve. The committee also noted that the RWE presented supported the understanding of dupilumab's long-term clinical effectiveness and informed assumptions for the economic model.ConclusionsTo date, the majority of products receiving an EAMS designation have not presented RWE at NICE reappraisal. The case of dupilumab illustrated how RWE collected through the EAMS can be used to reduce uncertainty around how clinical trial data can be translated into clinical practice. In the future, RWE may increasingly be used to help inform NICE decisions.


Author(s):  
Rogerio Lilenbaum ◽  
Natasha B. Leighl ◽  
Marcus Neubauer

One of the main challenges oncologists face in the care of patients with lung cancer is the decision to incorporate new clinical trial data into routine clinical practice. Beyond the question of statistical significance, which is a more objective metric, are the results meaningful and applicable to a broader population? Furthermore, in an era of value care, do the results justify a potential increase in costs? This article discusses the main points that clinicians consider in their decision-making process and illustrates the arguments with real-life examples.


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