Abstract:
:Clinical trial designs often fail to deliver data that jointly satisfy evolving demands of both regulatory and reimbursement authorities. We propose a new multi-tiered trial design to integrate efficacy and effectiveness, and address the evolving needs of authorities. The mixed randomized trial allocates patients first to trial arm - randomized controlled, pragmatic (randomized) or observational - and then to treatment group - experimental, placebo, active comparator, best available therapy or standard of care. Trial arms may be staggered over time to reflect the current state of randomized and non-randomized data of the experimental drug, and thereby still prioritize safety. At the same time, the mixed randomized trial allows for the collection of real-world data in a randomized setting, and thereby reduces selection bias.
journal_name
J Comp Eff Resjournal_title
Journal of comparative effectiveness researchauthors
Alsop J,Scott M,Archey Wdoi
10.2217/cer-2016-0034subject
Has Abstractpub_date
2016-11-01 00:00:00pages
569-579issue
6eissn
2042-6305issn
2042-6313journal_volume
5pub_type
杂志文章abstract:AIMS:To analyze administrative claims data from Medicaid, Medicare and commercial insurance sources to estimate stroke risk, bleeding risk, and the use of antithrombotic treatment in patients with atrial fibrillation (AF). METHODS:Included patients were aged ≥18 years with a new or existing diagnosis of AF. Outcomes w...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer.15.48
更新日期:2016-01-01 00:00:00
abstract::Aim: Indirect treatment comparisons are used when no direct comparison is available. Comparison networks should satisfy the transitivity assumption, that is, equal likelihood of treatment assignment for a given patient based on comparability of studies. Materials & methods: Seven criteria were evaluated across 18 rand...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2019-0064
更新日期:2019-11-01 00:00:00
abstract::There is increasing attention in the US healthcare system on the delivery of high-quality care, an issue central to oncology. In the report 'Crossing the Quality Chasm', the Institute of Medicine identified six aims for improving healthcare quality: safe, effective, patient-centered, timely, efficient and equitable. T...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2015-0021
更新日期:2016-05-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2018-0100
更新日期:2019-01-01 00:00:00
abstract:AIM:Laboratory test (lab) results may be useful to detect incident diabetes in electronic health record and claims-based studies. RESEARCH DESIGN & METHODS:Using the Mini-Sentinel distributed database, we assessed the value of lab results added to diagnosis codes and dispensing claims to identify incident diabetes. R...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2016-0033
更新日期:2017-01-01 00:00:00
abstract:AIM:To measure the private and social benefits of donor insemination (DI). METHODS:An empirical model investigates the general public and DI clients' willingness to pay (WTP) for DI, and the willingness of potential donors to become altruistic or paid sperm donors. RESULTS:The general public and DI clients value DI a...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章,多中心研究
doi:10.2217/cer-2016-0066
更新日期:2017-03-01 00:00:00
abstract:AIM:To understand researcher capability for and interest in patient-centered comparative effectiveness research (PC-CER), particularly related to engaging with patients/caregivers. MATERIALS & METHODS:Web-based survey of 508 health researchers recruited via professional health research organizations. RESULTS:Most res...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2016-0063
更新日期:2017-05-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2020-0005
更新日期:2020-08-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer.12.41
更新日期:2012-09-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 评论,杂志文章
doi:10.2217/cer.13.57
更新日期:2013-09-01 00:00:00
abstract::Comparative effectiveness research (CER) calls for substantial changes in the way clinical research is conducted, interpreted and practically applied in the USA, in order to produce useful clinical evidence. Departing from classic efficacy and effectiveness research, the evolving CER paradigm requires structural and s...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章,评审
doi:10.2217/CER.12.23
更新日期:2012-05-01 00:00:00
abstract:AIM:To evaluate overall survival (OS) in unresectable American Joint Committee on Cancer (AJCC) stage I/II hepatocellular carcinoma (HCC) treated with drug-eluting-bead transarterial chemoembolization (DEB-TACE) versus best supportive care. MATERIALS & METHODS:OS in consecutive patients with AJCC stage I/II unresectab...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer.15.54
更新日期:2016-03-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章,meta分析
doi:10.2217/cer-2018-0120
更新日期:2019-04-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2016-0025
更新日期:2016-08-01 00:00:00
abstract:AIM:Studies on multiple sclerosis in Saudi Arabia remain scant, particularly studies on the psychological aspects. This study measures severities of depression, anxiety and stress, and compares them to the used disease-modifying treatment. MATERIALS & METHODS:Cross-sectional study using a phone questionnaire targeting...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章,多中心研究
doi:10.2217/cer-2016-0087
更新日期:2017-07-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2018-0132
更新日期:2019-05-01 00:00:00
abstract::Aim: To evaluate the patterns of cancer patients-assessed quality of outpatient care in the USA. Materials & methods: Medical Expenditure Panel Survey datasets for the years 2011, 2013, 2015 and 2017 were accessed and adult participants with a history of cancer diagnosis were reviewed. Participants' assessments of dif...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2020-0124
更新日期:2020-09-01 00:00:00
abstract::Aim: Medicaid versus private primary insurance status may predict in-hospital mortality and morbidity after total knee arthroplasty (TKA). Materials & methods: Regression models were used to test our hypothesis in patients in the State Inpatient Database (SID) from five states who underwent primary TKA from January 20...
journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2019-0027
更新日期:2019-10-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer.14.72
更新日期:2014-11-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2018-0141
更新日期:2019-05-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer.12.7
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer.15.42
更新日期:2015-11-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
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更新日期:2015-09-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章,多中心研究
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更新日期:2018-07-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章,meta分析
doi:10.2217/cer-2019-0016
更新日期:2019-07-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer-2019-0071
更新日期:2019-12-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer.14.54
更新日期:2015-01-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章,评审
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章
doi:10.2217/cer.14.2
更新日期:2014-03-01 00:00:00
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journal_title:Journal of comparative effectiveness research
pub_type: 杂志文章,评审
doi:10.2217/cer.12.63
更新日期:2012-11-01 00:00:00